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A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
EU CTIS ID: 2023-505678-14-00
What this study is testing
To evaluate the safety and efficacy of lutikizumab compared to adalimumab in adult participants with moderately to severely active ulcerative colitis (UC).
- Therapeutic exploratory (Phase II)
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
- Participant has had a diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.
- Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.
You likely can't join if
- Current diagnosis of CD or inflammatory bowel disease-unclassified.
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Israel
- New Zealand
- Puerto Rico
- Serbia
- Switzerland
- South Africa
- Brazil
- Korea, Republic of
- Egypt
- Canada
- Taiwan
- Japan
- Turkey
- Argentina
- United States
- United Kingdom
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Israel; New Zealand; Puerto Rico; Serbia; Switzerland and 12 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.