VTX958 for the Treatment of Moderately to Severely Active Crohns Disease
- Conditions
- Health Condition 1: K509- Crohns disease, unspecified
- Registration Number
- CTRI/2023/11/059563
- Lead Sponsor
- PSI CRO Pharma India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1. Men or women, 18 to 75 years of age, inclusive, at the time of consent
2. Capable of giving signed informed consent
3. Documented diagnosis of CD = 3 months prior to Day 1. The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
4. Moderately to severely active CD
1. Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
2. Presence of a stoma or ileoanal pouch
3. Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
4. Known diagnosis of short gut or bowel syndrome
5. Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in mean Crohns disease Activity Index (CDAI) score from baseline to week 12 <br/ ><br>2. The proportion of participants achieving endoscopic response at Week 12Timepoint: During screening to week 12
- Secondary Outcome Measures
Name Time Method