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Taking people in ChinaPhase 2

Testing Several Drugs for Ulcerative Colitis or Crohn's Disease in Adults

Tests new drugs in adults with moderate to severe ulcerative colitis or Crohn's disease.

Plain-language title generated from the registry record
Registry title: A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

Key facts

Where
Changsha, Changzhou, Guangzhou, Hangzhou, Huizhou, Suzhou, Wenzhou, Xiamen, and Zhenjiang, ChinaSee the 9 sites
Phase
Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis or Crohn's disease who did not respond well to earlier treatment. The study lasts at least 62 weeks.

Age
18 to 80 years
Sex
Women and men
Disease stage
Moderately to severely active ulcerative colitis (modified Mayo score 5-9, Endoscopic Subscore at least 2, rectal bleeding at least 1) or Crohn's disease (CDAI score 220 to 450, with a set endoscopic score), diagnosed for at least 3 months.
Earlier treatment
Must have had an inadequate response, loss of response, or intolerance to at least one of: corticosteroids, immunomodulators, or an advanced therapy. Must not have failed more than 5 approved advanced treatments with different ways of working, or an anti-IL-23p19 antibody treatment.

Main reasons for not taking part

  • Diagnosis of IBD-unclassified or primary sclerosing cholangitis
  • Ulcerative colitis and Crohn's disease at the same time
  • Bowel resection or intestinal or abdominal surgery as set out in the protocol
  • Complications such as stricture, stenosis or short bowel syndrome
  • Significant uncontrolled illness that could affect safety or the study data

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT07483073, who can take part

Where in China

  • The Second Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
  • Changzhou Second People's HospitalChangzhou, ChinaTaking people
  • The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
  • Huizhou Central People's HospitalHuizhou, ChinaTaking people
  • The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
  • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical universityWenzhou, ChinaTaking people
  • Zhongshan Hospital Affiliated to Xiamen UniversityXiamen, ChinaTaking people
  • Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Eli Lilly and Company
Trial code
NCT07483073EU 2025-524112-11-00
Record updated
4 November 2026
Original description
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.Read full original descriptionShow less

A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Inclusion: Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD; For UC:; Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1; For CD:; Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease; Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD; Have screening laboratory test results within the protocol specified parameters.

Exclusion: Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol; Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment; Must not have received or will need any prohibited medications for UC or CD as specified in the protocol; Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis; For UC - must not have a current diagnosis of CD; For CD - must not have a current diagnosis of UC; Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome; Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data; Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action.

ClinicalTrials.gov NCT07483073 · EU CTIS 2025-524112-11-00