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

Phase 2

Active, not recruiting

• Conditions: Ulcerative Colitis

• Registration Number: 2023-505678-14-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

To evaluate the safety and efficacy of lutikizumab compared to adalimumab in adult participants with moderately to severely active ulcerative colitis (UC).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-14
• Study Start: 2024-03-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-15
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Not specified
• Target Recruitment: 156

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve Endoscopic Improvement at week 12		Percentage of Participants who Achieve Endoscopic Improvement at week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12		Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12
Percentage of Participants who Achieve Clinical Response Per mMS at week 12		Percentage of Participants who Achieve Clinical Response Per mMS at week 12
Percentage of Participants who Achieve Endoscopic Remission at week 12		Percentage of Participants who Achieve Endoscopic Remission at week 12

Trial Locations

Locations (191)

Gastro SB /ID# 258331; 🇺🇸 Chula Vista, California, United States

Southern California Res. Ctr. /ID# 258391; 🇺🇸 Coronado, California, United States

Newport Huntington Medical Group /ID# 258371; 🇺🇸 Huntington Beach, California, United States

Om Research LLC /ID# 261383; 🇺🇸 Lancaster, California, United States

UC Irvine Health /ID# 259824; 🇺🇸 Orange, California, United States

University of Colorado Hospital /ID# 258388; 🇺🇸 Aurora, Colorado, United States

Research Associates of South Florida, LLC /ID# 259813; 🇺🇸 Coral Gables, Florida, United States

University of Florida College of Medicine /ID# 260402; 🇺🇸 Gainesville, Florida, United States

Auzmer Research /ID# 260940; 🇺🇸 Lakeland, Florida, United States

Atlantic Medical Research /ID# 258507; 🇺🇸 Margate, Florida, United States

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