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
- Conditions
- Ulcerative Colitis
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 96
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.
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
- Arm && Interventions
Group Intervention Description Induction Group 1 Adalimumab Matching Placebo Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Adalimumab placebo will be utilized to maintain the blind. Maintenance Group 1 Lutikizumab Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Adalimumab placebo will be utilized to maintain the blind. Induction Group 1 Lutikizumab Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Adalimumab placebo will be utilized to maintain the blind. Induction Group 2 Adalimumab Matching Placebo Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind. Induction Group 2 Lutikizumab Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind. Induction Group 3 Lutikizumab Matching Placebo Participants will receive adalimumab per label throughout induction. Lutikizumab placebo will be utilized to maintain the blind. Induction Group 3 Adalimumab Participants will receive adalimumab per label throughout induction. Lutikizumab placebo will be utilized to maintain the blind. Maintenance Group 1 Adalimumab Matching Placebo Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Adalimumab placebo will be utilized to maintain the blind. Maintenance Non-Responders Lutikizumab Participants who do not respond to study drug at the end of induction period will receive open label SC lutikizumab in the maintenance period. Optional Long-Term Extension (LTE) Adalimumab Participants who complete the maintenance period, are willing/able to inject study drug at home, and in whom therapeutic benefit to study drug is confirmed by the investigator may participate in the optional 52-week blinded LTE. Maintenance Group 2 Lutikizumab Matching Placebo Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind. Maintenance Group 2 Adalimumab Matching Placebo Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind. Maintenance Group 2 Lutikizumab Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind. Maintenance Adalimumab Lutikizumab Matching Placebo Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period. Lutikizumab placebo will be utilized to maintain the blind. Maintenance Adalimumab Adalimumab Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period. Lutikizumab placebo will be utilized to maintain the blind. Optional Long-Term Extension (LTE) Lutikizumab Participants who complete the maintenance period, are willing/able to inject study drug at home, and in whom therapeutic benefit to study drug is confirmed by the investigator may participate in the optional 52-week blinded LTE.
- 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
Scroll for more (181 remaining)Gastro SB /ID# 258331🇺🇸Chula Vista, California, United States