[M23-703] 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

JRCT ID: jRCT2031240064

Registered date:07/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 07/05/2024
• Target sample size: 200
• Countries of recruitment: Australia,Japan,Puerto Rico,Japan,Poland,Japan,Canada,Japan,Hungary,Japan,Spain,Japan,Italy,Japan,France,Japan,United States of America,Japan,Germany,Japan,Belgium,Japan,Greece,Japan,United Kingdom,Japan,Switzerland,Japan,Latvia,Japan,Egypt,Japan,Lithuania,Japan,Estonia,Japan,Ireland,Japan,Norway,Japan,Slovenia,Japan,Brazil,Japan,Netherlands,Japan,Croatia,Japan,Taiwan,Japan,Serbia,Japan,Turkey,Japan,Chile,Japan,South Africa,Japan,Argentina,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

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.
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.

Outcome(s)

Primary Outcome

Outcome Measure: Percentage of Participants who Achieve Endoscopic Improvement
Measure Description: Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).
Time Frame: Week 12

Outcome Measure: Number of Participants with Adverse Events (AEs)
Measure Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame: Up to approximately Week 64

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06067568