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Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efavaleukin alfa
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, UC, Efavaleukin Alfa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specific activities or procedures. In Japan, if a participant is younger than 20 years at the time of signing the informed consent, the informed consent must be obtained from both the participant and their legal representative.
  • Men and women aged ≥ 18 to < 80 years at screening visit (≥ 19 to < 80 in South Korea).
  • Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate.
  • Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read rectosigmoidoscopy endoscopic subscore ≥ 2 and no subscore < 1 prior to day 1.

  • Has documentation of:

    • A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of > 8 years duration, or participants with left-sided colitis of > 12 years duration, or participants with primary sclerosing cholangitis.
    • For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study, at the discretion of the investigator.

  • Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase [JAK]-inhibitor), as follows:

    1. Conventional therapy failed participants:

      • Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone [or equivalent] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids).
      • History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment).
      • Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing.
      • History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor [TNF] antibody, anti-integrin antibody, or interleukin [IL]-12/23 antagonists) that is indicated for the treatment of UC.

    2. Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria:

      • Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use.
      • Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy or JAK inhibitor).
      • Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals or JAK inhibitors (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication).

  • If receiving any of the following therapies, participants must have stable dosage for the specified duration:

    • 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy.
    • Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy.
    • Budesonide: extended release tablets 9 mg/day [budensonide MMX], stable dose for ≥ 2 weeks prior to screening endoscopy.
    • Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy.

Key Exclusion Criteria:

  • Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
  • Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
  • Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study.
  • Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath).

  • Participant has received any of the following prescribed medication or therapy within the specified time period:

    • Anti TNF antibodies (eg, infliximab, adalimumab, golimumab) < 8 weeks prior to screening rectosigmoidoscopy.
    • Anti integrin antibodies (eg, vedolizumab) < 8 weeks prior to screening rectosigmoidoscopy.
    • IL 12/23 antagonist (eg, ustekinumab) < 8 weeks prior to screening rectosigmoidoscopy.
    • JAK inhibitors (eg, tofacitinib) < 4 weeks prior to screening rectosigmoidoscopy.
    • Any other commercially approved biologic agent or targeted small molecule < 8 weeks prior to screening rectosigmoidoscopy or < 5 half lives prior to screening rectosigmoidoscopy, whichever is longer
    • Immunomodulatory medications, including oral cyclosporine, intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide < 4 weeks prior to screening rectosigmoidoscopy.
    • Any investigational biologic therapy within 8 weeks prior to screening rectosigmoidoscopy or < 5 half-lives prior to screening rectosigmoidoscopy, whichever is longer.
    • Has used apheresis (eg, Adacolumnâ apheresis) < 2 weeks prior to screening rectosigmoidoscopy.

Sites / Locations

  • Digestive Health Specialists of the SoutheastRecruiting
  • Birmingham Digestive Health Research, LLCRecruiting
  • Arizona Health ResearchRecruiting
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Southern California Research CenterRecruiting
  • United Medical DoctorsRecruiting
  • Biopharma Informatic IncRecruiting
  • Santa Maria Gastroenterology Medical GroupRecruiting
  • Gastroenterology Center of Connecticut, PCRecruiting
  • West Central GastroenterologyRecruiting
  • Homestead Associates In Research IncRecruiting
  • Indian Health Service Health ResearchRecruiting
  • University of Miami Hospital and ClinicRecruiting
  • Ocala Gastrointestinal Research, LLCRecruiting
  • Atlanta Gastroenterology AssociatesRecruiting
  • Columbus Regional Research Institute, LLC
  • Grand Teton Research GroupRecruiting
  • Rush University Medical CenterRecruiting
  • Digestive Research Alliance of MichianaRecruiting
  • University of Kansas Medical CenterRecruiting
  • Mid-Atlantic GI Research, LLCRecruiting
  • Harvard Medical School - Brigham and Womens HospitalRecruiting
  • University of Massachusetts Memorial Medical CenterRecruiting
  • University of Michigan Health System
  • Clinical Research Institute of MichiganRecruiting
  • West Michigan Clinical Research CenterRecruiting
  • Southern Therapy and Advanced Research LLC - Jackson
  • Gastrointestinal Associates Research, LLCRecruiting
  • bvl Clinical ResearchRecruiting
  • Interspond - Las Vegas Medical ResearchRecruiting
  • Aga Clinical Research Associates LLCRecruiting
  • Affiliates in Gastroenterology Digestive Disease ResearchRecruiting
  • Atlantic Digestive Health InstituteRecruiting
  • Premier Health Research LLCRecruiting
  • New York University Langone Medical CenterRecruiting
  • Consultants for Clinical ResearchRecruiting
  • Digestive Specialists Inc Research, LLCRecruiting
  • Options Health Research, LLC
  • Guthrie Robert Packer HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Wake Research-ClinSearch, LLCRecruiting
  • Digestive Health Research, LLCRecruiting
  • Anrc ResearchRecruiting
  • Digestive Health AssociatesRecruiting
  • Digestive Research of Central Texas, LLCRecruiting
  • Digestive Health Research of North Texas LLCRecruiting
  • Emeritas Research GroupRecruiting
  • Blue Ridge Medical ResearchRecruiting
  • North Richmond Health ResearchRecruiting
  • GI Select Health Research LLCRecruiting
  • Hunter Holmes McGuire Veterans Medical CenterRecruiting
  • Wisconsin Center for Advanced ResearchRecruiting
  • Centro de Investigaciones Medicas Mar del PlataRecruiting
  • Clinica IndependenciaRecruiting
  • Cer Instituto MedicoRecruiting
  • CardioAlem InvestigacionesRecruiting
  • Hospital Privado Centro Medico de Cordoba SARecruiting
  • Fundacion Estudios ClinicosRecruiting
  • Medizinische Universitaet InnsbruckRecruiting
  • Landeskrankenhaus SalzburgRecruiting
  • Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
  • Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
  • Second Multiprofile Hospital for Active Treatment - Sofia EADRecruiting
  • Diagnostic-Consultative Center Convex EOODRecruiting
  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOODRecruiting
  • South Edmonton Gastroenterology
  • London Health Sciences Centre, University HospitalRecruiting
  • TIDHI Innovation IncorporatedRecruiting
  • Hepato-Gastroenterologie HK sroRecruiting
  • Nemocnice Pardubickeho kraje as, Pardubicka nemocniceRecruiting
  • Nemocnice Milosrdnych sester sv Karla Boromejskeho v PrazeRecruiting
  • Axon Clinical sroRecruiting
  • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
  • Aalborg Universitetshospital
  • Herlev HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • Bispebjerg HospitalRecruiting
  • Helsinki University Central HospitalRecruiting
  • Centre Hospitalier Universitaire Amiens PicardieRecruiting
  • Centre Hospitalier Universitaire de Montpellier - Hopital Saint EloiRecruiting
  • Centre Hospitalier Universitaire Archet 2Recruiting
  • Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital NordRecruiting
  • Gastro-Studien GbR Studienzentrum
  • Universitaetsklinikum EssenRecruiting
  • Universitaetsklinikum FrankfurtRecruiting
  • Universitaetsklinikum Schleswig-HolsteinRecruiting
  • Universitaetsklinikum Tuebingen
  • Universitaetsklinikum UlmRecruiting
  • University General Hospital of AlexandroupolisRecruiting
  • General Hospital EvangelismosRecruiting
  • Laiko General Hospital of AthensRecruiting
  • University Hospital AttikonRecruiting
  • Venizeleio General HospitalRecruiting
  • University Hospital of HeraklionRecruiting
  • University General Hospital of IoanninaRecruiting
  • General University Hospital of Patras Panagia i VoithiaRecruiting
  • Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal TagkorhazRecruiting
  • MIND Klinika KftRecruiting
  • Clinexpert KftRecruiting
  • Obudai Egeszsegugyi Centrum KftRecruiting
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi KarRecruiting
  • Clinfan KftRecruiting
  • Komarom-Esztergom Varmegyei Szent Borbala KorhazRecruiting
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaRecruiting
  • Azienda Ospedaliera Universitaria Renato DulbeccoRecruiting
  • Azienda Ospedaliero Universitaria CareggiRecruiting
  • Ospedale Policlinico San Martino IRCCSRecruiting
  • Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Ospedale Sacro Cuore Don CalabriaRecruiting
  • Ospedale Sandro PertiniRecruiting
  • Tsujinaka Hospital KashiwanohaRecruiting
  • Toho University Sakura Medical CenterRecruiting
  • Kitakyushu Municipal Medical CenterRecruiting
  • Gifu University HospitalRecruiting
  • Matsunami General HospitalRecruiting
  • Hakodate Central General HospitalRecruiting
  • Sapporo Tokushukai HospitalRecruiting
  • Aoyama Clinic GI Endoscopy and IBD CenterRecruiting
  • Gokeikai Ofuna Chuo HospitalRecruiting
  • Takagi ClinicRecruiting
  • Miyazaki Prefectural Miyazaki HospitalRecruiting
  • Nagasaki University HospitalRecruiting
  • Nara Medical University HospitalRecruiting
  • National Hospital Organization Okayama Medical CenterRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Tokyo Medical and Dental University HospitalRecruiting
  • Kitasato University Kitasato Institute HospitalRecruiting
  • Ome Municipal General HospitalRecruiting
  • Medical Corporation ENEXT Ikebukuro West Gate HospitalRecruiting
  • Yamanashi Prefectural Central HospitalRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Yeungnam University HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea Seoul St Marys HospitalRecruiting
  • Wonju Severance Christian HospitalRecruiting
  • Pauls Stradins Clinical University HospitalRecruiting
  • Digestive Diseases Centre GASTRORecruiting
  • Clinicos Asociados BOCM SCRecruiting
  • Clinica de Investigacion en Reumatologia y Obesidad SCRecruiting
  • Investigacion Biomedica para el Desarrollo de Farmacos SA de CVRecruiting
  • CRI Centro Regiomontano de Investigacion SCRecruiting
  • Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBPRecruiting
  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SCRecruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Elisabeth-TweeSteden ZiekenhuisRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • NZOZ Twoje Zdrowie EL SpzooRecruiting
  • Centrum Medyczne Med-Gastr Sp zooRecruiting
  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz SpzooRecruiting
  • Centrum Medyczne Pratia PoznanRecruiting
  • BodyClinic spolka z ograniczona odpowiedzialnosciaRecruiting
  • Centrum Medyczne Melita MedicalRecruiting
  • EuroMediCare Przychodnia Specjalistyczna we WroclawiuRecruiting
  • Institutul Clinic FundeniRecruiting
  • Spitalul Universitar de Urgenta Militar Central Dr. Carol DavilaRecruiting
  • Clinica MedicumRecruiting
  • Spitalul de Oncologie Monza SRLRecruiting
  • Spitalul Clinic ColentinaRecruiting
  • Spitalul Clinic PelicanRecruiting
  • Fakultna Nemocnica s poliklinikou FD Roosevelta Banska BystricaRecruiting
  • Endomed, sroRecruiting
  • Gastro I, sroRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario de La PrincesaRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario La PazRecruiting
  • Inselspital BernRecruiting
  • Intesto BERecruiting
  • Kantonsspital St GallenRecruiting
  • Universitaetsspital ZuerichRecruiting
  • China Medical University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Antalya Egitim ve Arastirma HastanesiRecruiting
  • Uludag Universitesi Tip FakultesiRecruiting
  • Gaziantep Universitesi Tip FakultesiRecruiting
  • Istanbul Universitesi Istanbul Tip FakultesiRecruiting
  • Ege Universitesi Tip FakultesiRecruiting
  • Dokuz Eylul Universitesi Tip FakultesiRecruiting
  • Kocaeli Universitesi Tip FakultesiRecruiting
  • Mersin Universitesi Tip FakultesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm A: Efavaleukin alfa

Arm B: Efavaleukin alfa

Arm C: Efavaleukin alfa

Arm D: Placebo

Arm Description

Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)

Efavaleukin alfa Dose 2 administered by SC injection Q2W

Efavaleukin alfa Dose 3 administered by SC injection Q2W

Placebo Q2W

Outcomes

Primary Outcome Measures

Number of Participants with Clinical Remission at Week 12

Secondary Outcome Measures

Number of Participants with Clinical Response at Week 12
Number of Participants with Endoscopic Remission at Week 12
Number of Participants with Symptomatic Remission at Week 12
Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
Number of Participants with a Clinically Significant Change from Baseline in Histological Score at Week 12 as Measured by Geboes Score
Number of Participants who Experience One or More Treatment-emergent Adverse Events

Full Information

First Posted
July 26, 2021
Last Updated
October 4, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04987307
Brief Title
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Official Title
A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
June 22, 2024 (Anticipated)
Study Completion Date
April 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, UC, Efavaleukin Alfa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Efavaleukin alfa
Arm Type
Experimental
Arm Description
Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)
Arm Title
Arm B: Efavaleukin alfa
Arm Type
Experimental
Arm Description
Efavaleukin alfa Dose 2 administered by SC injection Q2W
Arm Title
Arm C: Efavaleukin alfa
Arm Type
Experimental
Arm Description
Efavaleukin alfa Dose 3 administered by SC injection Q2W
Arm Title
Arm D: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Q2W
Intervention Type
Drug
Intervention Name(s)
Efavaleukin alfa
Other Intervention Name(s)
AMG 592
Intervention Description
Efavaleukin alfa will be administered by subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by SC injection.
Primary Outcome Measure Information:
Title
Number of Participants with Clinical Remission at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of Participants with Clinical Response at Week 12
Time Frame
Week 12
Title
Number of Participants with Endoscopic Remission at Week 12
Time Frame
Week 12
Title
Number of Participants with Symptomatic Remission at Week 12
Time Frame
Week 12
Title
Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
Time Frame
Week 12
Title
Number of Participants with a Clinically Significant Change from Baseline in Histological Score at Week 12 as Measured by Geboes Score
Time Frame
Baseline to Week 12
Title
Number of Participants who Experience One or More Treatment-emergent Adverse Events
Time Frame
Up to 56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participant has provided informed consent prior to initiation of any study specific activities or procedures. Men and women aged ≥ 18 to < 80 years at screening visit (≥ 19 to < 80 in South Korea). Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate. Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2. Has documentation of: A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of > 8 years duration, or participants with left-sided colitis of > 12 years duration, or participants with primary sclerosing cholangitis. At the discretion of the investigator, a colonoscopy (instead of a rectosigmoidoscopy) may be performed as the screening endoscopy for this study. For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study. Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase [JAK]-inhibitor or or S1P modulators), as follows: Conventional therapy failed participants: Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone [or equivalent] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids). History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment). Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing. History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor [TNF] antibody, anti-integrin antibody, or interleukin [IL]-12/23 antagonists) that is indicated for the treatment of UC. Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria: Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use. Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy, JAK inhibitor, or S1P modulators). Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals, JAK inhibitors or S1P modulators (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication). If receiving any of the following therapies, participants must have stable dosage for the specified duration: 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy. Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy. Budesonide: extended release tablets 9 mg/day [budensonide MMX], stable dose for ≥ 2 weeks prior to screening endoscopy. Beclomethasone dipropionate: gastro-resistant prolonged-release tablet 5 mg/day, stable dose for >= 2 weeks prior to screening endoscopy. Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy. Key Exclusion Criteria: Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease. Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon. Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study. Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath). Participant has received any of the following prescribed medication or therapy within the specified time period: Anti TNF antibodies (eg, infliximab, adalimumab, golimumab) < 8 weeks prior to screening rectosigmoidoscopy. Anti integrin antibodies (eg, vedolizumab) < 8 weeks prior to screening rectosigmoidoscopy. IL 12/23 antagonist (eg, ustekinumab) < 8 weeks prior to screening rectosigmoidoscopy. JAK inhibitors (eg, tofacitinib) < 4 weeks prior to screening rectosigmoidoscopy. Any other commercially approved biologic agent or targeted small molecule < 8 weeks prior to screening rectosigmoidoscopy or < 5 half lives prior to screening rectosigmoidoscopy, whichever is longer Immunomodulatory medications, including oral cyclosporine, intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide < 4 weeks prior to screening rectosigmoidoscopy. Any investigational biologic therapy within 8 weeks prior to screening rectosigmoidoscopy or < 5 half-lives prior to screening rectosigmoidoscopy, whichever is longer. Has used apheresis (eg, Adacolumnâ apheresis) < 2 weeks prior to screening rectosigmoidoscopy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Name
Birmingham Digestive Health Research, LLC
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Health Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Individual Site Status
Recruiting
Facility Name
United Medical Doctors
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Biopharma Informatic Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Maria Gastroenterology Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93458
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Center of Connecticut, PC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Recruiting
Facility Name
West Central Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead Associates In Research Inc
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Indian Health Service Health Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami Hospital and Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocala Gastrointestinal Research, LLC
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Regional Research Institute, LLC
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Individual Site Status
Terminated
Facility Name
Grand Teton Research Group
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Research Alliance of Michiana
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid-Atlantic GI Research, LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Individual Site Status
Recruiting
Facility Name
Harvard Medical School - Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Research Institute of Michigan
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Name
West Michigan Clinical Research Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Therapy and Advanced Research LLC - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Terminated
Facility Name
Gastrointestinal Associates Research, LLC
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Name
bvl Clinical Research
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Individual Site Status
Recruiting
Facility Name
Interspond - Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Name
Aga Clinical Research Associates LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Individual Site Status
Recruiting
Facility Name
Affiliates in Gastroenterology Digestive Disease Research
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlantic Digestive Health Institute
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Health Research LLC
City
Sparta
State/Province
New Jersey
ZIP/Postal Code
07871
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Medical Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Specialists Inc Research, LLC
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Terminated
Facility Name
Guthrie Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Research-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Research, LLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Name
Anrc Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Research of Central Texas, LLC
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Research of North Texas LLC
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Individual Site Status
Recruiting
Facility Name
Emeritas Research Group
City
Lansdowne Town Center
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Ridge Medical Research
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Name
North Richmond Health Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Individual Site Status
Recruiting
Facility Name
GI Select Health Research LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States
Individual Site Status
Recruiting
Facility Name
Hunter Holmes McGuire Veterans Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600DHK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Independencia
City
Munro
State/Province
Buenos Aires
ZIP/Postal Code
1605
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cer Instituto Medico
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CardioAlem Investigaciones
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
B1642DSF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Privado Centro Medico de Cordoba SA
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
X5000IYH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Estudios Clinicos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Second Multiprofile Hospital for Active Treatment - Sofia EAD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnostic-Consultative Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
South Edmonton Gastroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Individual Site Status
Completed
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
TIDHI Innovation Incorporated
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hepato-Gastroenterologie HK sro
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Pardubickeho kraje as, Pardubicka nemocnice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze
City
Praha
ZIP/Postal Code
118 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Axon Clinical sro
City
Praha
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Individual Site Status
Terminated
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Terminated
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Bispebjerg Hospital
City
Kobenhavn NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Amiens Picardie
City
Amiens cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Archet 2
City
Nice cedex 3
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Gastro-Studien GbR Studienzentrum
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Individual Site Status
Terminated
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Individual Site Status
Recruiting
Facility Name
General Hospital Evangelismos
City
Athens
ZIP/Postal Code
10676
Country
Greece
Individual Site Status
Recruiting
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital Attikon
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Venizeleio General Hospital
City
Heraklion
ZIP/Postal Code
71409
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
71500
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Name
General University Hospital of Patras Panagia i Voithia
City
Patras
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Individual Site Status
Recruiting
Facility Name
MIND Klinika Kft
City
Budapest
ZIP/Postal Code
1024
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinexpert Kft
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum Kft
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinfan Kft
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Renato Dulbecco
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino IRCCS
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar VR
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Sandro Pertini
City
Roma
ZIP/Postal Code
00157
Country
Italy
Individual Site Status
Recruiting
Facility Name
Tsujinaka Hospital Kashiwanoha
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toho University Sakura Medical Center
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitakyushu Municipal Medical Center
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
802-8561
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsunami General Hospital
City
Hashima-gun
State/Province
Gifu
ZIP/Postal Code
501-6062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hakodate Central General Hospital
City
Hakodate-shi
State/Province
Hokkaido
ZIP/Postal Code
040-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aoyama Clinic GI Endoscopy and IBD Center
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gokeikai Ofuna Chuo Hospital
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takagi Clinic
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
981-3213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyazaki Prefectural Miyazaki Hospital
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nara Medical University Hospital
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ome Municipal General Hospital
City
Ome-shi
State/Province
Tokyo
ZIP/Postal Code
198-0042
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation ENEXT Ikebukuro West Gate Hospital
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-shi
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Wonju Severance Christian Hospital
City
Wonju-si, Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Digestive Diseases Centre GASTRO
City
Riga
ZIP/Postal Code
1079
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Clinicos Asociados BOCM SC
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03300
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad SC
City
Guadalajra
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
CRI Centro Regiomontano de Investigacion SC
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
NZOZ Twoje Zdrowie EL Spzoo
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Med-Gastr Sp zoo
City
Lodz
ZIP/Postal Code
91-034
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
City
Malbork
ZIP/Postal Code
82-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
BodyClinic spolka z ograniczona odpowiedzialnoscia
City
Warszawa
ZIP/Postal Code
03-712
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Melita Medical
City
Wroclaw-Krzyki
ZIP/Postal Code
50-449
Country
Poland
Individual Site Status
Recruiting
Facility Name
EuroMediCare Przychodnia Specjalistyczna we Wroclawiu
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinica Medicum
City
Bucuresti
ZIP/Postal Code
012015
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul de Oncologie Monza SRL
City
Bucuresti
ZIP/Postal Code
013812
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Pelican
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Individual Site Status
Recruiting
Facility Name
Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Endomed, sro
City
Kosice
ZIP/Postal Code
040 13
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Gastro I, sro
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Intesto BE
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital St Gallen
City
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Zuerich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Antalya Egitim ve Arastirma Hastanesi
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag Universitesi Tip Fakultesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep Universitesi Tip Fakultesi
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41001
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin Universitesi Tip Fakultesi
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

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