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A Study to Assess the Effectiveness and Safety of Induction Therapy with RO7790121 in Participants with Moderately to Severely Active Crohn's Disease
EU CTIS ID: 2024-513054-30-00
What this study is testing
To evaluate the efficacy of afimkibart compared with placebo in inducing response
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 to ≤ 80 years at the time of signing Informed Consent Form
- General Inclusion Criteria Bodyweight ≥ 40 kg
- Crohn's Disease-Specific Inclusion Criteria Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence
- Crohn's Disease-Specific Inclusion Criteria Moderately to severely active CD, meeting all of the following: - SES-CD of ≥ 6 (or ≥ 4 for isolated ileal disease) - CDAI ≥ 220 and ≤ 450
- Crohn's Disease-Specific Inclusion Criteria Involvement of ileum and/or colon, with at least four colonic segments traversable by an endoscope or a pediatric endoscope, or three segments (colon and/or ileum) for patients who have undergone a bowel resection among the following segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Crohn's Disease-Specific Inclusion Criteria Screening for colorectal cancer (CRC) during or prior to screening for all participants (performed according to local standards) With risk factors for bowel cancer a surveillance ileocolonoscopy must be performed within 12 months prior to screening. For all other patients, must be up-to date with CRC surveillance (according to CRC risks and local standards) Screening ileocolonoscopy can be used for CRC surveillance (following local guidelines) and results must be available prior to randomization Any adenomatous polyps must be completely removed according to routine practice prior to their first dose of study drug.
You likely can't join if
- Inflammatory Bowel Disease Exclusion Criteria Participant with a history of ≥ 3 bowel resections > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
- Inflammatory Bowel Disease Exclusion Criteria Diagnosis of short gut or short bowel syndrome
- Medical History Exclusion Criteria Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- Significant uncontrolled medical comorbidity (such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders [excluding CD]), psychiatric, or other condition that in the opinion of the investigator, would confound the study results, compromise patient safety, interfere with the potential participant's provision of informed consent, or compliance with trial procedures
- Infection or Infection Risk Exclusion Criteria Any clinically significant infection < 4 weeks prior to randomization that has not resolved, and/or that required hospitalization, and/or IV antibiotics o Any clinically significant infection that was opportunistic in nature is not permitted within 3 months prior to randomization
- Infection or Infection Risk Exclusion Criteria Confirmation of HIV infection (e.g., positive HIV test) at screening
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Costa Rica
- United Arab Emirates
- China
- Thailand
- Dominican Republic
- Egypt
- Korea, Republic of
- United Kingdom
- Panama
- India
- Chile
- Canada
- Saudi Arabia
- Brazil
- Taiwan
- Argentina
- United States
- Israel
- Guatemala
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Costa Rica; United Arab Emirates; China; Thailand; Dominican Republic and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.