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RecruitingPhase 2

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests long-acting antibodies, alone and in combinations, in adults with moderate to severe ulcerative colitis (UC), a disease that causes swelling and sores in the large intestine. It checks how well the treatments work and how safe they are, starting with medicine given into a vein, then shots under the skin.

This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had UC for at least 3 months before the first study day, confirmed by a scope exam and testing of tissue samples.
  • A screening scope exam shows UC extends at least 15 cm from the anus. About 15% of participants may have swelling only in the rectum.
  • Have moderate to severe active UC: a modified Mayo disease score of 5–9, a rectal bleeding score of at least 1, and a scope exam score of at least 2.

Who can't join

  • Have Crohn’s disease or inflammatory bowel disease whose type is unclear.
  • Have or may have very severe colon swelling, a dangerously enlarged colon, a hole in the bowel, or another condition likely to need surgery during the first treatment stage.
  • Have tried treatments from 4 or more types of advanced therapy without success, including approved or experimental treatments.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis) * Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2 Exclusion Criteria: * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined * Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction * Failed 4 or more approved or investigational advanced therapy classes

Study sites (26)

CA

CO

FL

IL

KS

KY

LA

MA

MD

MN

NC

NY

RI

TN

TX

WA