A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (UC)

JRCT ID: jRCT2031210352

Registered date:28/09/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 28/02/2022
• Target sample size: 35
• Countries of recruitment: USA,Japan,Australia,Japan,Taiwan,Japan,S. Korea,Japan,Belarus,Japan,Russia,Japan,Ukraine,Japan,Moldova,Japan,Georgia,Japan,Germany,Japan,Hungary,Japan,Czech Republic,Japan,Slovakia,,Japan,Serbia,Japan,Italy,Japan,Estonia,Japan,Bulgaria,Japan,Poland,Japan
• Study type: Interventional
• Intervention(s): Double-blinded Treatment Period : Oral administration of 2 capsules of 0.2 mg or 0.4 mg amiselimod or placebo once a day for 2 weeks, and oral administration of one cupsule once a day for 10 weeks. Open Label Extension Period: Oral administration of 0.4 mg amiselimod once a day for up to 36 weeks.

Outcome(s)

• Primary Outcome: The modified Mayo Score will be used for the primary efficacy evaluation.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Male or female subjects aged between 18 to 75 years (inclusive) at the time of the subject's signing of the informed consent.
2. Normal vital signs.
- afebrile,
- heart rate 55-100 bpm,
- systolic blood pressure >90 and <150 mmHg,
- diastolic blood pressure >50 and <90 mmHg,
- respiration rate >10 and <20/min. 3. Diagnosis of active mild to moderate UC (modified Mayo Score of 3 to 8) confirmed at least 12 weeks prior to randomization by clinical and endoscopic evidence (corroborated by a histopathology report).
- Mild UC is defined as a modified Mayo Score of 3 or 4.
- Moderate UC is defined as a modified Mayo Score of 5 to 8.
4. An endoscopic subscore from screening colonoscopy of >=2 as determined by a central reviewer.
5. Evidence of active UC extending >=15 cm from the anal verge confirmed by a screening colonoscopy.
6. If subjects are receiving oral or rectal 5-aminosalicylates (5-ASAs) or oral corticosteroids (<=20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization.
7. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit and a urine pregnancy test at each subsequent study visit and agree to use an acceptable method of contraception throughout their participation in the study and for 12 weeks after the last dose of IMP. See Section 7.6 for details on methods of contraception.
8. Willingness and ability to complete training in the use of the subject diary and to complete the subject diary in a timely manner throughout the study.

Exclude criteria

Exclusion Criteria Related to Ulcerative Colitis
1. Diagnosis of Crohn's disease, indeterminate colitis, colitis (pseudomembranous, microscopic, or ischemic) or coeliac disease.
2. Current or recent (within 12 weeks prior to randomization) evidence of fulminant colitis, abdominal abscess, toxic megacolon, bowel obstruction, or bowel perforation.
3. Diagnosis of proctitis, defined as a rectal inflammation within 15 cm from the anal verge.
4. History or evidence of any colonic resection or subtotal colectomy within 1 year prior to randomization.
5. History or evidence of ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
6. History or evidence of unresected adenomatous colonic polyps or colonic mucosal dysplasia.
7. Current need for, or anticipated need for surgical intervention for UC during the study.

Related Information

• Primary Sponsor: Kagiyama Shoji
• Secondary ID(s): NCT04857112