Phase 3 Program to Evaluate Tulisokibart for Moderate to Severe Crohn's Disease

JRCT ID: jRCT2031240196

Registered date:28/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 03/08/2024
• Target sample size: 1200
• Countries of recruitment: United States of America,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Peru,Japan,Brazil,Japan,Austria,Japan,Belgium,Japan,Croatia,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Latvia,Japan,Lithuania,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Saudi Arabia,Japan,Serbia,Japan,Refer to 7-5,Japan
• Study type: Interventional

Intervention(s)

Study 1 Group 1: High dose induction (intravenous [IV] infusion), High dose maintenance (subctaneous [SC])
Study 1 Group 2: High dose induction (IV infusion), Low dose maintenance (SC)
Study 1 Group 3: Low dose induction (IV infusion), Low dose maintenance (SC)
Study 1 Group 4: Placebo induction (IV infusion), Placebo maintenance (SC)
Study 1 Extension: High dose or Low dose extension (SC)
Study 2 Group 1: High dose induction (IV infusion)
Study 2 Group 2: Low dose induction (IV infusion)
Study 2 Group 3: Placebo induction (IV infusion)
Study 2 Extension: High dose or Low dose extension (SC)

Outcome(s)

Primary Outcome

- Study1: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score at Week 52
- Study1: Percentage of Participants Achieving Endoscopic Response at Week 52
- Study1, 2: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
- Study1, 2: Percentage of Participants Achieving Endoscopic Response at Week 12
- Study1, 2: Percentage of Participants Who Experienced an Adverse Event (AE)
- Study1, 2: Percentage of Participants who Discontinue Study Intervention due to an AE

Secondary Outcome

- Study1, 2: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
- Study1, 2: Percentage of Participants with Decrease of >=100 Points in CDAI Score from Baseline to Week 12
- Study1, 2: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12
-Study1, 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
- Study1, 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
- Study1, 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
- Study1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study1: Percentage of Participants with Decrease of >=100 Points in CDAI Score from Baseline to Week 52
- Study1: Percentage of Participants Achieving Endoscopic Remission at Week 52
-Study1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Both Week 12 and Week 52
- Study1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
- Study1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
- Study1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52
- Study1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52
- Study1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
- Study1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52
- Study2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
- Study2: Percentage of Participants with Decrease of >=100 Points in CDAI Score from Baseline to Week 6
- Study2: The percentage of Participants with Ulcer-Free Endoscopy at Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

- Has had a diagnosis of CD at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.

Exclude criteria

- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has current stoma or need for colostomy or ileostomy.
- Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-anti-TL1A antibody.

Related Information

• Primary Sponsor: Maeda Yoshikazu
• Secondary ID(s): NCT06430801