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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lutikizumab — DRUG
  Subcutaneous (SC) Injection
• Lutikizumab — DRUG
  Intravenous (IV) Infusion
• Adalimumab — DRUG
  SC Injection

Study Details

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 participants with moderate to severe 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 moderate to severe 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 lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 200 sites worldwide. During the 12 week Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab. 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. Participants who do not respond to treatment will receive SC lutikizumab. Participants who complete the Week 52 visit and in whom therapeutic benefit to study drug is confirmed by the investigator may roll over into an optional, 52-week long-term extension (LTE). 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.

Key Dates

Start date

Mar 23, 2024

Status verified

Oct 2025

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

156 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Induction Group 1
  Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
• Experimental: Induction Group 2
  Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
• Experimental: Induction Group 3
  Participants will receive adalimumab per label throughout induction.
• Experimental: Maintenance Group 1
  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.
• Experimental: Maintenance Group 2
  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.
• Experimental: Maintenance Adalimumab
  Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.
• Experimental: Maintenance Non-Responders
  Participants who do not respond to study drug at the end of induction period will receive SC lutikizumab in the maintenance period.
• Experimental: Optional Long-Term Extension (LTE)
  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 LTE.

Primary Outcome Measure

Percentage of Participants who Achieve Endoscopic Improvement [ Time Frame: Week 12 ]

Locations (48)

Find similar trials in Chula Vista, CA

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