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A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) (INSTRUCT-UC)

Primary Purpose

Colitis, Ulcerative

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3471851
Placebo
Sponsored by
Nektar Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring T regulatory cells (Tregs), Interleukin 2, Interleukin-2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) ≥2, with endoscopy performed within 14 days before baseline.
  • Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of involved colon).
  • Have up-to-date colorectal cancer surveillance performed according to local standard.
  • Participants are either one of the following:
  • Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
  • Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
  • Have had an established diagnosis of UC of ≥3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
  • Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.

Exclusion Criteria:

  • Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
  • Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening.
  • Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
  • Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor).
  • Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
  • Have any history or evidence of cancer of the gastrointestinal tract
  • Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.

Sites / Locations

  • Dedicated Clinical Research
  • I.H.S. Health, LLC
  • Gastroenterology Associates of Pensacola, PA
  • Atlantic Digestive Health Institute
  • Biopharma Informatic, LLC
  • Southern Star Research Institute, LLC
  • Care Access Research - Ogden
  • DOM- Centro de Reumatologia
  • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC
  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
  • Centro Médico Privado de Reumatología
  • Concord Repatriation General Hospital
  • Paratus Clinical Research Brisbane
  • Mater Adult Hospital Brisbane
  • St. Vincent's Hospital
  • Université Libre de Bruxelles - Hôpital Erasme
  • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
  • AZ Maria Middelares
  • Chronos Pesquisa Clínica
  • Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS
  • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
  • Pesquisare
  • Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual
  • Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
  • CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
  • Hepatogastro
  • Gastroenterology and internal medicine research institute
  • Gastroenterology Research, Nova Scotia Health Authority
  • CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne
  • McGill University
  • The First Affiliated Hospital of Anhui Medical University
  • First affiliated Hospital of Sun Yat-Sen University
  • The Sixth Affiliated Hospital, Sun Yat-Sen University
  • Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • The First Affiliated Hospital of Nanchang University
  • Taian City Central Hospital
  • Shanghai Jiaotong University School of Medicine Ruijin Hospital
  • Sir Run Run Shaw Hospital
  • A-Shine
  • MUDr. Gregar, s.r.o.
  • PreventaMed, s.r.o.
  • I. Interni klinika FN Plzen
  • Nemocnice Slaný
  • CHU De Grenoble Hopital Albert Michallon
  • Centre Hospitalier de Mont de Marsan
  • Acad. F. Todua Medical Center - Research Institute of Clinical Medicine
  • Medical Center: Medinvestment
  • Clinexpert SMO
  • Óbudai Egészségügyi Centrum
  • Bugát Pál Kórház
  • CLINFAN Szolgáltató Kft
  • Shree Giriraj Multispeciality Hospital
  • Gujarat Hospital - Gastro and Vascular Centre
  • Kingsway Hospital
  • Midas Multispeciality Hospital Pvt.Ltd.
  • SR Kalla Memorial Gastro & General Hospital
  • Apollo Speciality Hospital - Teynampet
  • Postgraduate Institute of Medical Education & Research
  • Gandhi Hospital
  • Soroka Medical Center
  • Galilee Medical Center - Internal A
  • Kaplan Medical Center
  • Fukuoka University Chikushi Hospital
  • Tokushukai Sapporo Tokushukai Hospital
  • Sapporo Medical University Hospital
  • Infusion Clinic
  • Sai Gastroenterologist Proctology
  • Matsuda Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Showa University Koto Toyosu Hospital
  • Kyorin University Hospital
  • Fukuoka University Hospital
  • Sameshima Hospital
  • Toyama Prefectural Central Hospital
  • Yamagata University Hospital
  • Ajou University Hospital
  • Samsung Medical Center
  • Seoul St. Mary's Hospital
  • Inje University Haeundae Paik Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Pauls Stradins Clinical Univeristy Hospital
  • NZOZ Vivamed
  • Szpital Miejski Sw. Jana Pawla II
  • WIP Warsaw IBD Point Profesor Kierkus
  • ETG Zamość
  • SC Pelican SRL
  • SC Med Life SA
  • SC Centrul Medical Sana SRL
  • Spital Clinic Colentina
  • Spitalul Clinic Judetean de Urgenta Cluj
  • S.C. Materna Care S.R.L.
  • Olla-Med
  • Novosibirski Gastrocenter
  • Rostov State Medical University
  • Open Joint Stock Company Clinical and Diagnostic Center Euromedservice
  • The University Clinic of OSMU
  • SPb SBIH "City Mariinskaya Hospital"
  • GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health
  • FNsP FDRoosevelta Banska Bystrica
  • ENDOMED s.r.o.
  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
  • Lviv Railway Clinical Hospital
  • Lviv Regional Endocrinology Dispensary
  • Medical Center of LLC Medical Center Clinic of Family Medicine
  • International Institute of Clinical Trials LLC
  • Communal Enterprise "Odesa Regional Clinical Hospital"
  • A. Novak Transcarpathian Regional Clinical Hospital
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • Vinnytsia War Veterans Regional Clinical Hospital
  • Diacenter LLC
  • Royal Derby Hospital
  • Whipps Cross University Hospital
  • Guys/St. Thomas Hospital
  • St. George's Hospital
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose LY3471851

Low dose LY3471851

Placebo

Arm Description

Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved Clinical Remission at Week 12
Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.

Secondary Outcome Measures

Percentage of Participants Who Achieved Clinical Response at Week 12
Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Percentage of Participants Who Achieved Endoscopic Remission at Week 12
Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Percentage of Participants Who Achieved Symptomatic Remission at Week 12
Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Percentage of Participants Who Achieved Symptomatic Response at Week 12
Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Percentage of Participants Who Achieved Histologic Remission at Week 12
Histologic Remission is defined as Geboes score <2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
HEMH is defined as Geboes score <2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4 to 6] or [7 to 9]) and region (North America/Europe/Other) as fixed factors.
Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12
C-trough is the concentration of drug in the blood immediately before the next dose was administered.

Full Information

First Posted
December 8, 2020
Last Updated
August 8, 2023
Sponsor
Nektar Therapeutics
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04677179
Brief Title
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Acronym
INSTRUCT-UC
Official Title
An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to enrollment futility.
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
August 9, 2022 (Actual)
Study Completion Date
August 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nektar Therapeutics
Collaborators
Eli Lilly and Company

4. Oversight

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

5. Study Description

Brief Summary
The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.
Detailed Description
In stage 1, two doses (high and low) of LY3471851 will be compared to placebo. In stage 2, up to two additional doses (to be confirmed) of LY3471851 will be compared to placebo. LY3471851 (NKTR-358) is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
T regulatory cells (Tregs), Interleukin 2, Interleukin-2

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
High dose LY3471851
Arm Type
Experimental
Arm Description
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Arm Title
Low dose LY3471851
Arm Type
Experimental
Arm Description
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Intervention Type
Drug
Intervention Name(s)
LY3471851
Other Intervention Name(s)
NKTR-358
Intervention Description
administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinical Remission at Week 12
Description
Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinical Response at Week 12
Description
Clinical response is defined as a decrease in the MMS of ≥2 points and ≥30% decrease from baseline, and a decrease of ≥1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Endoscopic Remission at Week 12
Description
Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Endoscopic Response at Week 12
Description
Endoscopic response is defined as a decrease of ≥1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Symptomatic Remission at Week 12
Description
Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of ≥1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Symptomatic Response at Week 12
Description
Symptomatic response is defined as a ≥30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Histologic Remission at Week 12
Description
Histologic Remission is defined as Geboes score <2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
Description
HEMH is defined as Geboes score <2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
Time Frame
Week 12
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
Description
IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4 to 6] or [7 to 9]) and region (North America/Europe/Other) as fixed factors.
Time Frame
Baseline, Week 12
Title
Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12
Description
C-trough is the concentration of drug in the blood immediately before the next dose was administered.
Time Frame
Predose at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) ≥2, with endoscopy performed within 14 days before baseline. Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of involved colon). Have up-to-date colorectal cancer surveillance performed according to local standard. Participants are either one of the following: Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR, Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment. Have had an established diagnosis of UC of ≥3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents. Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug. Exclusion Criteria: Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease. Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening. Have had or will need abdominal surgery for UC (for example, subtotal colectomy). Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor). Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon. Have any history or evidence of cancer of the gastrointestinal tract Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Nektar Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Dedicated Clinical Research
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
I.H.S. Health, LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Gastroenterology Associates of Pensacola, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Atlantic Digestive Health Institute
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Southern Star Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Care Access Research - Ogden
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
DOM- Centro de Reumatologia
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1111
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
City
Ciudad Autonoma De Buenos Air
State/Province
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
Facility Name
Centro Médico Privado de Reumatología
City
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Paratus Clinical Research Brisbane
City
Albion
State/Province
Queensland
ZIP/Postal Code
4010
Country
Australia
Facility Name
Mater Adult Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4700
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Université Libre de Bruxelles - Hôpital Erasme
City
Brussels
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
City
Tournai
State/Province
Wallonne, Région
ZIP/Postal Code
7500
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Chronos Pesquisa Clínica
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
72145-450
Country
Brazil
Facility Name
Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430-001
Country
Brazil
Facility Name
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Pesquisare
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
City
São Bernardo do Campo
State/Province
São Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
Hepatogastro
City
Sao Paulo
ZIP/Postal Code
04543-001
Country
Brazil
Facility Name
Gastroenterology and internal medicine research institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
Gastroenterology Research, Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Facility Name
CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2H1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
HefeiCity
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
First affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Sixth Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
City
Wu Han
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Taian City Central Hospital
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Shanghai Jiaotong University School of Medicine Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
A-Shine
City
Pilsen
State/Province
Plzeň-město
ZIP/Postal Code
312 00
Country
Czechia
Facility Name
MUDr. Gregar, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
I. Interni klinika FN Plzen
City
Plzen-Lochotin
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Nemocnice Slaný
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
CHU De Grenoble Hopital Albert Michallon
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier de Mont de Marsan
City
Mont-de-Marsan Cedex
ZIP/Postal Code
40024
Country
France
Facility Name
Acad. F. Todua Medical Center - Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Medical Center: Medinvestment
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Clinexpert SMO
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Óbudai Egészségügyi Centrum
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Bugát Pál Kórház
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
CLINFAN Szolgáltató Kft
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360004
Country
India
Facility Name
Gujarat Hospital - Gastro and Vascular Centre
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395009
Country
India
Facility Name
Kingsway Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440001
Country
India
Facility Name
Midas Multispeciality Hospital Pvt.Ltd.
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
SR Kalla Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Apollo Speciality Hospital - Teynampet
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600035
Country
India
Facility Name
Postgraduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Gandhi Hospital
City
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Galilee Medical Center - Internal A
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Tokushukai Sapporo Tokushukai Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
004 0041
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Infusion Clinic
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Sai Gastroenterologist Proctology
City
Fujiidera
State/Province
Osaka
ZIP/Postal Code
583-0027
Country
Japan
Facility Name
Matsuda Hospital
City
Hamamatsu-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
4328061
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
162 8655
Country
Japan
Facility Name
Showa University Koto Toyosu Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135 8577
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Sameshima Hospital
City
Kagoshima
ZIP/Postal Code
892-0846
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
ZIP/Postal Code
930-8550
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Ajou University Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
443380
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical Univeristy Hospital
City
Riga
State/Province
Rīga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
NZOZ Vivamed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Szpital Miejski Sw. Jana Pawla II
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Name
ETG Zamość
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
SC Pelican SRL
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
SC Med Life SA
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
SC Centrul Medical Sana SRL
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Spital Clinic Colentina
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
S.C. Materna Care S.R.L.
City
Timisoara
ZIP/Postal Code
300645
Country
Romania
Facility Name
Olla-Med
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
Novosibirski Gastrocenter
City
Novosibirsk
State/Province
Novosibirskaya Oblast'
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
State/Province
Rostovskaya Oblast'
ZIP/Postal Code
344091
Country
Russian Federation
Facility Name
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice
City
Moscow
Country
Russian Federation
Facility Name
The University Clinic of OSMU
City
Omsk
ZIP/Postal Code
644050
Country
Russian Federation
Facility Name
SPb SBIH "City Mariinskaya Hospital"
City
Saint-Petersburg
ZIP/Postal Code
194104
Country
Russian Federation
Facility Name
GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
FNsP FDRoosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
ENDOMED s.r.o.
City
Kosice
ZIP/Postal Code
04013
Country
Slovakia
Facility Name
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
City
Kiev
State/Province
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Lviv Railway Clinical Hospital
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Lviv Regional Endocrinology Dispensary
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Medical Center of LLC Medical Center Clinic of Family Medicine
City
Dnipro
Country
Ukraine
Facility Name
International Institute of Clinical Trials LLC
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Communal Enterprise "Odesa Regional Clinical Hospital"
City
Odesa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
A. Novak Transcarpathian Regional Clinical Hospital
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Vinnytsia War Veterans Regional Clinical Hospital
City
Vinnytsia
Country
Ukraine
Facility Name
Diacenter LLC
City
Zaporizhzhia
ZIP/Postal Code
69076
Country
Ukraine
Facility Name
Royal Derby Hospital
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guys/St. Thomas Hospital
City
London
State/Province
Surrey
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/V3FQqG8aJfjj6JtJ60xFt
Description
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) ( INSTRUCT-UC )

Learn more about this trial

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

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