Health Condition 1: K509- Crohns disease, unspecified
Conditions
Interventions
Intervention1: VTX958: Doses 225mg, 300mg BID Orally
- Study drug should be taken by participants with approximately 240 mL (one cup) of water twice a day in the morning and evening (12 hours apart).
Sponsors
PSI CRO Pharma India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in mean Crohns disease Activity Index (CDAI) score from baseline to week 12 2. The proportion of participants achieving endoscopic response at Week 12Timepoint: During screening to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean simple endoscopic score in Crohns disease SES-CD at Week 12 - Change from baseline in mean simple endoscopic score in Crohns disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, & presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.Timepoint: During screening to week 12;Proportion of participants achieving both endoscopic response (outcome- measure # 2) & clinical remission (outcome measure # 4) at Week 12 - Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.Timepoint: During screening to week 12;Proportion of participants achieving clinical remission at Week 12 - Clinical remission is defined as a CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.Timepoint: During screening to week 12;Proportion of participants achieving clinical response at Week 12 - Proportion of participants achieving clinical response at Week 12. A clinical response is defined as = 100 points reduction from baseline in CDAI score or CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, & general well-being, are p | — |
Countries
Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, France, Georgia, Germany, Hungary, India, Israel, Italy, Lithuania, Poland, Serbia, Slovakia, Spain, United States of America
Contacts
Public ContactDr Radhika Bobba
PSI CRO pharma India Pvt Ltd
Outcome results
None listed