RightFit
RecruitingPhase 2 / Phase 3

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

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 and older
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 study tests how well icotrokinra works and how safe it is for people with moderate to severe active Crohn’s disease. Crohn’s disease is a long-term illness that causes swelling and irritation in the digestive tract.

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

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

Eligibility

Who can join

  • You were diagnosed with Crohn’s disease at least 12 weeks before screening, confirmed by a camera exam of the bowel and a tissue sample report.
  • Your Crohn’s symptoms are moderate to severe, with a disease activity score of 220–450. You also average at least 4 bowel movements a day or have an average daily belly pain score of at least 2.
  • A camera exam shows active Crohn’s disease with sores in the small bowel, large bowel, or both. The bowel exam score must be at least 6, or at least 4 if only the last part of the small bowel is affected.
  • If you can become pregnant, you must have negative blood and urine pregnancy tests before treatment and agree to more pregnancy tests.
  • Standard treatments did not work well enough or caused side effects you could not tolerate, and you have not tried advanced treatments; or advanced treatments did not work well enough or caused side effects you could not tolerate.

Who can't join

  • You have Crohn’s complications that may need surgery during the study or make treatment results hard to measure. Examples include bowel narrowing that causes symptoms or short gut syndrome, when too little bowel remains.
  • You have a stoma or ostomy—an opening made by surgery to let bowel waste leave the body.
  • You have active fistulas—unusual tunnels from the bowel—that need surgery. Fistulas that do not need surgery may be allowed.
  • You had part of your large bowel removed within 24 weeks before the study starts, or other major surgery within 12 weeks before it starts.
  • Your screening bowel exam finds adenomatous polyps—growths that can turn into cancer—outside areas of known bowel inflammation, and they are not removed before you are assigned to a study group.

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

Official eligibility criteria

Inclusion Criteria: * Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2 * Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests * Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \[ADT\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder \[IR\]) as defined in the protocol Exclusion criteria: * Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention * Presence of a stoma or ostomy * Participants with presence of active fistulas may be included if there is no surgery needed * Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline * Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Study sites (61)

AZ

CA

CO

CT

FL

GA

IN

KS

KY

LA

MD

MN

NC

NY

OK

OR

PA

RI

SC

TX

VA

WA