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The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cobitolimod 250 mg
Cobitolimod 500 mg
Placebo
Sponsored by
InDex Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Colitis, Ulcerative, Gastrointestinal Disease, Inflammatory Bowel Diseases, Glucocorticosteroids, Anti-Inflammatory Agents, Therapeutic uses, Cobitolimod, Toll like receptor 9 agonist, TLR9 agonist, Kappaproct, IDX0150, DIMS0150

Eligibility Criteria

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

Inclusion Criteria Induction:

  • Male or female ≥ 18 years of age.
  • Established diagnosis of UC.
  • Moderate to severe active left-sided UC assessed by central reading.
  • Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
  • Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
  • Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.

Exclusion Criteria Induction:

  • Suspicion of differential diagnosis.
  • Acute fulminant UC and/or signs of systemic toxicity.
  • UC limited to the rectum or extending beyond the splenic flexure.
  • Have failed treatment with more than three advanced therapies of two different therapeutic classes.
  • Have had surgery for treatment of UC.
  • History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
  • History or presence of any clinically significant disorder.
  • Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
  • Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
  • Long-term treatment (>14 days) with antibiotics or NSAIDs .
  • Serious known active infection including history of latent or active tuberculosis.
  • Gastrointestinal infections including positive Clostridium difficile stool assay.
  • Females who are lactating or have a positive serum pregnancy test.
  • Women of childbearing potential not using highly effective contraceptive methods.
  • Concurrent participation in another clinical study.
  • Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

  • Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

  • Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

Sites / Locations

  • Amicis Research CenterRecruiting
  • Allameh Medical CorporationRecruiting
  • Prospective Research Innovations Inc.Recruiting
  • Valiance Clinical Research
  • RecioMed Clinical Research Network, Inc.Recruiting
  • MB & V Medical ResearchRecruiting
  • A+ Research, Inc.Recruiting
  • SouthCoast Research Center, IncRecruiting
  • I.V.A.M. Clinical & Investigational Center LLCRecruiting
  • D&H National Research Centers, Inc.
  • Medical Professionals Clinical Research CenterRecruiting
  • Gastroenterology Group Of NaplesRecruiting
  • Alliance Clinical Research - GastroenterologyRecruiting
  • Cotton O'Neil Clinical Research CenterRecruiting
  • Clinical Research Institute of MichiganRecruiting
  • Lenox Hill HospitalRecruiting
  • Carolina Digestive Health Associates, PARecruiting
  • Carolina ResearchRecruiting
  • Peters Medical ResearchRecruiting
  • Dayton GastroenterologyRecruiting
  • Digestive Health Associates of Texas, PARecruiting
  • Clinical Research Solution: Digestive Health AssociatesRecruiting
  • Baylor College of Medicine - Gastroeneterology
  • Gastroenterology Associates of Northern VirginiaRecruiting
  • Wisconsin Center For Advanced ResearchRecruiting
  • Monash HealthRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • The Alfred HospitalRecruiting
  • Royal Melbourne HospitalRecruiting
  • Mater Health ServicesRecruiting
  • Princess Alexandra HospitalRecruiting
  • MedUn InnsbruckRecruiting
  • LKH KlagenfurtRecruiting
  • Universitätsklinikum SalzburgRecruiting
  • Akh WienRecruiting
  • UZ AntwerpenRecruiting
  • Imelda ZiekenhuisRecruiting
  • Erasme University Hospital
  • Universitair Ziekenhuis GentRecruiting
  • AZ Groeninge - Campus KennedylaanRecruiting
  • AZ DeltaRecruiting
  • University Clinical Centre of the Republic of Srpska - GastroenterologyRecruiting
  • The University Hospital FocaRecruiting
  • Clinical Center University of Sarajevo - GastroenterologyRecruiting
  • General Hospital "Prim.dr.Abdulah Nakas"
  • Polyclinic Dr. Al-TawilRecruiting
  • Opca Bolnica TesanjRecruiting
  • Plava Medical GroupRecruiting
  • Cantonal Hospital ZenicaRecruiting
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Hospital de Clinicas de Porto Alegre - Centro de Pesquisa ClinicaRecruiting
  • Ufrj - Hospital Universitario Clementino Fraga FilhoRecruiting
  • Praxis Pesquisa MedicaRecruiting
  • Kaiser ClinicaRecruiting
  • CEMEC - Centro Multidisciplinar de Estudos ClinicosRecruiting
  • MUMC - Hamilton Health Sciences
  • Installation Hospital Maisonneuve-Rosemont
  • Royal University Hospital
  • Opca bolnica BjelovarRecruiting
  • Clinical Hospital OsijekRecruiting
  • Opca bolnica PulaRecruiting
  • Zadar General HospitalRecruiting
  • Poliklinika SolmedRecruiting
  • University Hospital Centre ZagrebRecruiting
  • Aalborg University Hospital
  • Aarhus University Hospital
  • Herlev Hospital
  • Hillerod Hospital
  • Lillebælt Hospital Vejle
  • CHRU de Lille - Hôpital Claude HuriezRecruiting
  • CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologieRecruiting
  • CHU de Nancy BraboisRecruiting
  • CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, HépatologieRecruiting
  • Hopital Saint AntoineRecruiting
  • Hopital Bichat - GastroenterologyRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Universitaire de PoitiersRecruiting
  • CHU de Saint Etienne, Hôpital Nord - Service de GastroentérologieRecruiting
  • CHU Amiens - Hopital Sud - Service Hepato-GastroenterologRecruiting
  • Centre Hospitalier Universitaire de Toulouse - Hopital RangueilRecruiting
  • JSC " Evex Hospitals"Recruiting
  • LTD Israel-Georgian Medical Research Clinic HelsicoreRecruiting
  • Universitätsklinikum Augsburg
  • Charité - Universitätsmedizin Berlin KöRRecruiting
  • University Hospital Cologne AöRRecruiting
  • MVZ Sanaklinikum Duisburg
  • Universitätsklinikum ErlangenRecruiting
  • Agaplesion Markus KrankenhausRecruiting
  • Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
  • Universitätsklinikum FreiburgRecruiting
  • Uniklinik Halle (Saale)Recruiting
  • Gastroenterology Outpatient Clinic Prof. Dr. med. EhehaltRecruiting
  • University Hospital Schleswig-HolsteinRecruiting
  • Universitätsmedizin MannheimRecruiting
  • Medius Klinik NürtingenRecruiting
  • Universitätsklinikum RostockRecruiting
  • Universitätsklinikum UlmRecruiting
  • Internistische Praxis WeyheRecruiting
  • Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.Recruiting
  • Pannónia Magánorvosi Centrum KftRecruiting
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai KlinikaRecruiting
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar
  • SzTE Szt-Gy A Orvostud Kar Bel KlinRecruiting
  • The Barzilai Medical CenterRecruiting
  • The Edith Wolfson Medical CenterRecruiting
  • Hadassah Medical Organization, Hadassah Medical Center, Ein-Recruiting
  • Shaare Zedek Medical CenterRecruiting
  • Galilee Medical Center (Western Galilee Hospital)
  • Kaplan Medical Center
  • ASST Papa Giovanni XXIII - Cardiologia - Bergamo
  • AO Brotzu
  • Universita degli Studi di Firenze - Azienda Ospedaliero - Un
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliera San Gerardo
  • AOU di Padova
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
  • Policlinico Universitario Agostino GemelliRecruiting
  • Policlinico Universitario Campus BiomedicoRecruiting
  • A.O. Ordine Mauriziano Di Torino
  • AOU S. Maria della MisericordiaRecruiting
  • Universita degli Studi dell'Insubria - Ospedale di Circolo e
  • Inje University Haeundae Paik HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Hanyang University Guri HospitalRecruiting
  • Kyung Hee University Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Kyung Hee University Hospital - Internal MedicineRecruiting
  • Kyung Hee University HospitalRecruiting
  • The Catholic University of Korea, St. Vincent's HospitalRecruiting
  • Yonsei University, Wonju Severance Christian HospitalRecruiting
  • Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
  • Klaipeda Seamen's HospitalRecruiting
  • Republic Klaipeda HospitalRecruiting
  • Panevezio ligonineRecruiting
  • Vilniaus Universiteto ligonines Santariskiu KlinikosRecruiting
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Recruiting
  • Medical Care and Research S. A. de C. VRecruiting
  • Clinicos Asociados Bocm, S.C.Recruiting
  • Centro Regiomontano de Estudios Clinicos Roma SCRecruiting
  • Clinical Research Institute S.C.Recruiting
  • Radboud University Medical CenterRecruiting
  • Akershus UniversitetssykehusRecruiting
  • Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8Recruiting
  • Vestfold Hjertesenter As
  • Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
  • MPS - MED sp. z o.o.Recruiting
  • MZ Badania Slowik Zymla Spolka jawnaRecruiting
  • Centrum Medyczne PROMEDRecruiting
  • Krakowskie Centrum Medyczne Sp. z o.o.Recruiting
  • Centrum Medyczne PlejadyRecruiting
  • Szpital Zakonu Bonifratrow Sw. Jana Bozego w LodziRecruiting
  • Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.Recruiting
  • Twoja Przychodnia - Opolskie Centrum MedyczneRecruiting
  • Medicome Sp. z o.o.Recruiting
  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuRecruiting
  • ETG SkierniewiceRecruiting
  • KO-MED Centra Kliniczne Staszow
  • Twoja Przychodnia - SCMRecruiting
  • GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety LekarskieRecruiting
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Bodyclinic sp. z o.o. sp.k.Recruiting
  • Centralny Szpital Kliniczny MSWiA w WarszawieRecruiting
  • PlanetMed
  • ETG ZamoscRecruiting
  • Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)Recruiting
  • Hospital de BragaRecruiting
  • Hospital Beatriz Angelo (HBA)Recruiting
  • Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São SebastiãoRecruiting
  • Spitalul Clinic Colentina
  • Sana MonitoringRecruiting
  • Spitalul Clinic Judetean de Urgenta Cluj-NapocaRecruiting
  • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
  • Cabinet Particular Policlinic Algomed
  • Spitalul Clinic Judetean Mures
  • Clinic Center of SerbiaRecruiting
  • Clinical Hospital Center "Dr. Dragisa Misovic"Recruiting
  • Euromedik HospitalRecruiting
  • Zvezdara University Medical Center
  • Clinical Center Kragujevac - Center for GastroenterohepatologyRecruiting
  • General Hospital Dr Djordje JoanovicRecruiting
  • General hospital Zrenjanin
  • FNsP F.D.R. Banska BystricaRecruiting
  • CLINIQ s.r.o.Recruiting
  • ENDOMED s.r.o.Recruiting
  • GASTROMEDIC, s.r.o.Recruiting
  • Accout Center s.r.o.Recruiting
  • Karolinska Universitetssjukhuset - Gastroenterology
  • Uppsala University Hospital, AkademiskaRecruiting
  • Örebro Univ. HospitalRecruiting
  • Hacettepe University Medical Faculty - HematologyRecruiting
  • Istanbul University Medical FacultyRecruiting
  • Mersin Universtiy Medical Faculty
  • Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
  • Accellacare Warwickshire Quality Research Site
  • County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
  • Glasgow Royal Infirmary
  • North West London Hospitals NHS Trust
  • Central Middlesex Hospital
  • Kings College Hospital
  • Accellacare North London
  • Accellacare Limited/Accellacare of South London
  • Royal Berkshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cobitolimod 250 mg

Cobitolimod 500 mg

Placebo

Arm Description

Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week

Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week

Dose of Placebo 2 treatments during induction study and subsequently every third week

Outcomes

Primary Outcome Measures

Induction - Proportion of participants with clinical remission.
Clinical remission defined by the 3-component Mayo score.
Maintenance - Proportion of participants with clinical remission.
Clinical remission defined by the 3-component Mayo score.

Secondary Outcome Measures

Induction - Proportion of participants with endoscopic improvement.
Endoscopic improvement defined by the Mayo Endoscopic score.
Induction - Proportion of participants with symptomatic remission.
Symptomatic remission defined by the 2-component Mayo score.
Induction - Proportion of participants with clinical response.
Clinical remission defined by the 3-component Mayo score.
Induction - Proportion of participants with normalisation of stool frequency.
Stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with absence of rectal bleeding.
Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Induction - Mean stool frequency.
Mean stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with histologic improvement.
Defined by the Robarts Histologic Index.
Induction - Proportion of participants with histologic remission.
Histologic remission defined by the Robarts Histologic Index.
Induction - Proportion of participants with mucosal healing.
Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Induction - Mean ln-transformed faecal calprotectin.
Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.
Induction - Mean 3-component and 4-component Mayo scores.
Defined by 3-component and 4-component Mayo scores.
Induction - Mean IBDQ total score.
Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).
Induction - Proportion of participants with an improvement in IBDQ total score.
Defined by the IBDQ.
Maintenance - Proportion of participants with endoscopic improvement.
Endoscopic improvement defined by the Mayo Endoscopic score.
Maintenance - Proportion of participants with clinical remission and steroid-free.
Defined by the 3-component Mayo score and use of glucocorticosteroids.
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission
Defined by the 3-component Mayo score.
Maintenance - Proportion of participants with symptomatic remission.
Symptomatic remission defined by the 2-component Mayo score.
Maintenance - Proportion of participants with histologic improvement.
Histologic improvement defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with histologic remission.
Histologic remission defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with mucosal healing.
Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Maintenance - Proportion of participants with clinical response.
Clinical response defined by the 3-component Mayo score.
Maintenance - Proportion of participants with absence of rectal bleeding.
Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Maintenance - Proportion of participants with normalisation of stool frequency.
Stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean stool frequency.
Mean stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean ln-transformed faecal calprotectin.
Mean ln-transformed faecal calprotectin.
Maintenance - Mean 3-component and 4-component Mayo scores.
Defined by 3-component and 4-component Mayo scores.
Maintenance - Mean IBDQ total score.
Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).
Maintenance - Proportion of participants with an improvement in IBDQ total score.
Defined by the IBDQ.

Full Information

First Posted
July 22, 2021
Last Updated
December 15, 2022
Sponsor
InDex Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04985968
Brief Title
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Acronym
CONCLUDE
Official Title
A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InDex Pharmaceuticals

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 purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
Detailed Description
This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks. In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Colitis, Ulcerative, Gastrointestinal Disease, Inflammatory Bowel Diseases, Glucocorticosteroids, Anti-Inflammatory Agents, Therapeutic uses, Cobitolimod, Toll like receptor 9 agonist, TLR9 agonist, Kappaproct, IDX0150, DIMS0150

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cobitolimod 250 mg
Arm Type
Experimental
Arm Description
Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week
Arm Title
Cobitolimod 500 mg
Arm Type
Experimental
Arm Description
Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose of Placebo 2 treatments during induction study and subsequently every third week
Intervention Type
Drug
Intervention Name(s)
Cobitolimod 250 mg
Other Intervention Name(s)
Kappaproct
Intervention Description
Rectal administration
Intervention Type
Drug
Intervention Name(s)
Cobitolimod 500 mg
Other Intervention Name(s)
Kappaproct
Intervention Description
Rectal administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Rectal administration
Primary Outcome Measure Information:
Title
Induction - Proportion of participants with clinical remission.
Description
Clinical remission defined by the 3-component Mayo score.
Time Frame
Week 6
Title
Maintenance - Proportion of participants with clinical remission.
Description
Clinical remission defined by the 3-component Mayo score.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Induction - Proportion of participants with endoscopic improvement.
Description
Endoscopic improvement defined by the Mayo Endoscopic score.
Time Frame
Week 6
Title
Induction - Proportion of participants with symptomatic remission.
Description
Symptomatic remission defined by the 2-component Mayo score.
Time Frame
Week 6
Title
Induction - Proportion of participants with clinical response.
Description
Clinical remission defined by the 3-component Mayo score.
Time Frame
Week 6
Title
Induction - Proportion of participants with normalisation of stool frequency.
Description
Stool frequency defined by the Mayo score for Stool Frequency.
Time Frame
Week 6
Title
Induction - Proportion of participants with absence of rectal bleeding.
Description
Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Time Frame
Week 6
Title
Induction - Mean stool frequency.
Description
Mean stool frequency defined by the Mayo score for Stool Frequency.
Time Frame
Week 6
Title
Induction - Proportion of participants with histologic improvement.
Description
Defined by the Robarts Histologic Index.
Time Frame
Week 6
Title
Induction - Proportion of participants with histologic remission.
Description
Histologic remission defined by the Robarts Histologic Index.
Time Frame
Week 6
Title
Induction - Proportion of participants with mucosal healing.
Description
Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Time Frame
Week 6
Title
Induction - Mean ln-transformed faecal calprotectin.
Description
Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.
Time Frame
Week 6
Title
Induction - Mean 3-component and 4-component Mayo scores.
Description
Defined by 3-component and 4-component Mayo scores.
Time Frame
Week 6
Title
Induction - Mean IBDQ total score.
Description
Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).
Time Frame
Week 6
Title
Induction - Proportion of participants with an improvement in IBDQ total score.
Description
Defined by the IBDQ.
Time Frame
Week 6
Title
Maintenance - Proportion of participants with endoscopic improvement.
Description
Endoscopic improvement defined by the Mayo Endoscopic score.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with clinical remission and steroid-free.
Description
Defined by the 3-component Mayo score and use of glucocorticosteroids.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission
Description
Defined by the 3-component Mayo score.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with symptomatic remission.
Description
Symptomatic remission defined by the 2-component Mayo score.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with histologic improvement.
Description
Histologic improvement defined by the Robarts Histologic Index.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with histologic remission.
Description
Histologic remission defined by the Robarts Histologic Index.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with mucosal healing.
Description
Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with clinical response.
Description
Clinical response defined by the 3-component Mayo score.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with absence of rectal bleeding.
Description
Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Time Frame
Week 52
Title
Maintenance - Proportion of participants with normalisation of stool frequency.
Description
Stool frequency defined by the Mayo score for Stool Frequency.
Time Frame
Week 52
Title
Maintenance - Mean stool frequency.
Description
Mean stool frequency defined by the Mayo score for Stool Frequency.
Time Frame
Week 52
Title
Maintenance - Mean ln-transformed faecal calprotectin.
Description
Mean ln-transformed faecal calprotectin.
Time Frame
Week 52
Title
Maintenance - Mean 3-component and 4-component Mayo scores.
Description
Defined by 3-component and 4-component Mayo scores.
Time Frame
Week 52
Title
Maintenance - Mean IBDQ total score.
Description
Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).
Time Frame
Week 52
Title
Maintenance - Proportion of participants with an improvement in IBDQ total score.
Description
Defined by the IBDQ.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Induction: Male or female ≥ 18 years of age. Established diagnosis of UC. Moderate to severe active left-sided UC assessed by central reading. Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC. Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP. Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent. Exclusion Criteria Induction: Suspicion of differential diagnosis. Acute fulminant UC and/or signs of systemic toxicity. UC limited to the rectum or extending beyond the splenic flexure. Have failed treatment with more than three advanced therapies of two different therapeutic classes. Have had surgery for treatment of UC. History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured). History or presence of any clinically significant disorder. Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators. Treatment with rectal GCS, 5-ASA/SP or tacrolimus. Long-term treatment (>14 days) with antibiotics or NSAIDs . Serious known active infection including history of latent or active tuberculosis. Gastrointestinal infections including positive Clostridium difficile stool assay. Females who are lactating or have a positive serum pregnancy test. Women of childbearing potential not using highly effective contraceptive methods. Concurrent participation in another clinical study. Previous exposure to cobitolimod. Inclusion Criteria Maintenance: Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study. Exclusion Criteria Maintenance: Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
InDex Pharmaceuticals
Phone
+46 8 122 038 50
Email
info@indexpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Arlander, CDO
Phone
+46 8 122 038 70
Email
eva.arlander@indexpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Atreya, Professor
Organizational Affiliation
Friedrich-Alexander University Erlangen-Nuremberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amicis Research Center
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
Individual Site Status
Recruiting
Facility Name
Allameh Medical Corporation
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Name
Prospective Research Innovations Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
Valiance Clinical Research
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
RecioMed Clinical Research Network, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Individual Site Status
Recruiting
Facility Name
MB & V Medical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Recruiting
Facility Name
A+ Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
SouthCoast Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
I.V.A.M. Clinical & Investigational Center LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H National Research Centers, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical Professionals Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Group Of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance Clinical Research - Gastroenterology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
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
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Digestive Health Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Individual Site Status
Recruiting
Facility Name
Dayton Gastroenterology
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Individual Site Status
Recruiting
Facility Name
Digestive Health Associates of Texas, PA
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75019
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Solution: Digestive Health Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine - Gastroeneterology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Gastroenterology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
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
Monash Health
City
Clayton
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Alfred Hospital
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mater Health Services
City
South Brisbane
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Individual Site Status
Recruiting
Facility Name
MedUn Innsbruck
City
Innsbruck
Country
Austria
Individual Site Status
Recruiting
Facility Name
LKH Klagenfurt
City
Klagenfurt
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Salzburg
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Name
Akh Wien
City
Wien
Country
Austria
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Antwerpen
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Erasme University Hospital
City
Brussels
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge - Campus Kennedylaan
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Clinical Centre of the Republic of Srpska - Gastroenterology
City
Banja Luka
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
The University Hospital Foca
City
Foca
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Clinical Center University of Sarajevo - Gastroenterology
City
Sarajevo
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
General Hospital "Prim.dr.Abdulah Nakas"
City
Sarajevo
Country
Bosnia and Herzegovina
Individual Site Status
Not yet recruiting
Facility Name
Polyclinic Dr. Al-Tawil
City
Sarajevo
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Opca Bolnica Tesanj
City
Tesanj
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Plava Medical Group
City
Tuzla
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Cantonal Hospital Zenica
City
Zenica
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
City
Goiania
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Ufrj - Hospital Universitario Clementino Fraga Filho
City
Rio De Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Praxis Pesquisa Medica
City
Santo Andre
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Kaiser Clinica
City
Sao Jose do Rio Preto
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clinicos
City
São Bernardo do Campo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
MUMC - Hamilton Health Sciences
City
Hamilton
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Installation Hospital Maisonneuve-Rosemont
City
Montréal
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Royal University Hospital
City
Saskatoon
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Opca bolnica Bjelovar
City
Bjelovar
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Osijek
City
Osijek
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Opca bolnica Pula
City
Pula
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Zadar General Hospital
City
Zadar
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Poliklinika Solmed
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital Centre Zagreb
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Hillerod Hospital
City
Hillerød
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Lillebælt Hospital Vejle
City
Vejle
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
CHRU de Lille - Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nancy Brabois
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Antoine
City
Paris Cedex 12
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat - Gastroenterology
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog
City
Salouel
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Name
JSC " Evex Hospitals"
City
Batumi
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD Israel-Georgian Medical Research Clinic Helsicore
City
Tiflis
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charité - Universitätsmedizin Berlin KöR
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Cologne AöR
City
Cologne
Country
Germany
Individual Site Status
Recruiting
Facility Name
MVZ Sanaklinikum Duisburg
City
Duisburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt am main
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
City
Frankfurt am Main
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Name
Uniklinik Halle (Saale)
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Name
Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medius Klinik Nürtingen
City
Nürtingen
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Rostock
City
Rostock
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Name
Internistische Praxis Weyhe
City
Weyhe
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pannónia Magánorvosi Centrum Kft
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
City
Budapest
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
SzTE Szt-Gy A Orvostud Kar Bel Klin
City
Szeged
Country
Hungary
Individual Site Status
Recruiting
Facility Name
The Barzilai Medical Center
City
Ashkelon
Country
Israel
Individual Site Status
Recruiting
Facility Name
The Edith Wolfson Medical Center
City
H̱olon
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Organization, Hadassah Medical Center, Ein-
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Name
Galilee Medical Center (Western Galilee Hospital)
City
Nahariya
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
ASST Papa Giovanni XXIII - Cardiologia - Bergamo
City
Bergamo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AO Brotzu
City
Cagliari
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Universita degli Studi di Firenze - Azienda Ospedaliero - Un
City
Firenze
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AOU di Padova
City
Padova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Campus Biomedico
City
Rom
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Ordine Mauriziano Di Torino
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
AOU S. Maria della Misericordia
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Name
Universita degli Studi dell'Insubria - Ospedale di Circolo e
City
Varese
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Guri Hospital
City
Guri-Si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital - Internal Medicine
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyung Hee University Hospital
City
Soeul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-Si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yonsei University, Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipeda Seamen's Hospital
City
Klaipeda
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Republic Klaipeda Hospital
City
Klaipeda
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Panevezio ligonine
City
Panevezys
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilniaus Universiteto ligonines Santariskiu Klinikos
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Medical Care and Research S. A. de C. V
City
Merida
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinicos Asociados Bocm, S.C.
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro Regiomontano de Estudios Clinicos Roma SC
City
Monterrey
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute S.C.
City
Tlalnepantla
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Akershus Universitetssykehus
City
Lørenskog
Country
Norway
Individual Site Status
Recruiting
Facility Name
Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8
City
Tromsø
Country
Norway
Individual Site Status
Recruiting
Facility Name
Vestfold Hjertesenter As
City
Tønsberg
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
City
Ålesund
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
MPS - MED sp. z o.o.
City
Grudziadz
Country
Poland
Individual Site Status
Recruiting
Facility Name
MZ Badania Slowik Zymla Spolka jawna
City
Knurow
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne PROMED
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Krakow
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Plejady
City
Kraków
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
City
Lodz
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
City
Malbork
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Opolskie Centrum Medyczne
City
Opole
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medicome Sp. z o.o.
City
Oswiecim
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznan
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETG Skierniewice
City
Skierniewice
Country
Poland
Individual Site Status
Recruiting
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszow
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Twoja Przychodnia - SCM
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Name
GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie
City
Torun
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warsaw
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Bodyclinic sp. z o.o. sp.k.
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Name
PlanetMed
City
Wroclaw
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
ETG Zamosc
City
Zamosc
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)
City
Amadora
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Beatriz Angelo (HBA)
City
Loures
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião
City
Santa Maria da Feira
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Colentina
City
Bucharest
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Sana Monitoring
City
Bucuresti
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
City
Iasi
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Cabinet Particular Policlinic Algomed
City
Timişoara
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Spitalul Clinic Judetean Mures
City
Târgu Mureș
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Clinic Center of Serbia
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Center "Dr. Dragisa Misovic"
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Euromedik Hospital
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Zvezdara University Medical Center
City
Belgrad
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Clinical Center Kragujevac - Center for Gastroenterohepatology
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Name
General Hospital Dr Djordje Joanovic
City
Zrenjanin
Country
Serbia
Individual Site Status
Recruiting
Facility Name
General hospital Zrenjanin
City
Zrenjanin
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
FNsP F.D.R. Banska Bystrica
City
Banska Bystrica
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
CLINIQ s.r.o.
City
Bratislava
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
ENDOMED s.r.o.
City
Košice
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
GASTROMEDIC, s.r.o.
City
Nove Zamky
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Accout Center s.r.o.
City
Sahy
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset - Gastroenterology
City
Stockholm
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Uppsala University Hospital, Akademiska
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Örebro Univ. Hospital
City
Örebro
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty - Hematology
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Medical Faculty
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin Universtiy Medical Faculty
City
Mersin
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
City
Bury
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Accellacare Warwickshire Quality Research Site
City
Coventry
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
City
Darlington
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Glasgow Royal Infirmary
City
Glasgow
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
North West London Hospitals NHS Trust
City
Harrow
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Central Middlesex Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Kings College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Accellacare North London
City
Northwood
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Accellacare Limited/Accellacare of South London
City
Orpington
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

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