Horizon
Brief summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide. In the Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab for 12 weeks. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab until Week 52. Participants who do not respond to treatment will receive open-label SC lutikizumab until Week 52. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
18 Years and older.
Inclusion Criteria:
- Participant has had a diagnosis of Ulcerative Colitis (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.
Exclusion Criteria:
- Current diagnosis of Crohn's Disease (CD) or inflammatory bowel
disease-unclassified.
- Extent of inflammatory disease limited to the rectum as assessed by screening
endoscopy.
- Prior exposure to adalimumab (including biosimilars). Note: Subject may be enrolled
if he/she has been exposed to other advanced therapies, including anti-TNFs other
than adalimumab.
