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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

Testing Lutikizumab's effects on ulcerative colitis symptoms and safety.

Recruiting
18 years and older
All
Phase 2

This study is for adults with active ulcerative colitis (UC), which causes swelling and bleeding in the colon's lining. The study aims to test how safe and effective a new drug, lutikizumab, is compared to a current treatment, adalimumab. Participants will receive the medicine through an IV (intravenous, which means into a vein) or SC (subcutaneous, which means under the skin). The study has two parts: a 12-week Induction Period and a 52-week Maintenance Period. During the first 12 weeks, participants will get lutikizumab or adalimumab. After 12 weeks, those responding well to lutikizumab will continue with it, and those on adalimumab will stay on it. If the medicine isn't working, participants will switch to a different form of lutikizumab. Around 200 people will join this study, which will take place at about 280 locations worldwide. Participants might face more treatment steps than usual and will go for regular check-ups, blood tests, and fill out surveys.

  • The study lasts up to 52 weeks, with an optional additional 52-week extension.
  • Participants will visit clinics or hospitals regularly for check-ups.
  • There might be a higher treatment burden compared to usual care.
Study details
    Ulcerative Colitis

NCT06257875

AbbVie

5 July 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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