A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease.
- Conditions
- Crohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-003303-19-PL
- Lead Sponsor
- Reistone Biopharma Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
• Male or Female age = 18 and =75 years of age at randomization.
• Subjects with a documented at least three-month history of diagnosed ileal, colonic, or ileocolonic Crohn’s Disease at the time of randomization.
• Currently having Crohn’s Disease with Crohn’s Disease Activity Index (CDAI) score = 220 to =450.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 137
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
• Diagnosis of indeterminate colitis, or clinical findings suggestive of Ulcerative Colitis.
• Subject with CD with stoma, gastric or ileoanal pouch, proto-colectomy or total colectomy, symptomatic stenosis or stricture, history of bowel perforation, suspected abscess; actively draining fistula.
• Treatment naïve subjects diagnosed with Crohn’s disease (without previous exposure to any of the following therapies for CD treatment: 5-
ASA, corticosteroids, immune-suppressants, or biological treatment).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of SHR0302 compared to placebo in inducing clinical remission at Week 12.;Secondary Objective: • To evaluate the safety and tolerability of oral SHR0302<br>• To evaluate the efficacy of oral SHR0302 in inducing clinical remission at different time points<br>• To evaluate the efficacy of oral SHR0302 in inducing endoscopy response<br>• To evaluate the change from baseline in the following biomarkers; CRP, fecal calprotectin.<br>• To characterise the pharmacokinetics of oral SHR0302 and explore the correlation of exposure-response;Primary end point(s): The percentage of subjects achieving clinical remission at week 12, defined as Crohn’s Disease Activity Index (CDAI) score < 150.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method