A Phase 2, Multicenter, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants With Active Crohns Disease or Active Ulcerative Colitis
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Mirador Therapeutics, Inc
- Enrollment
- 210
- Locations
- 6
- Primary Endpoint
- a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values
Overview
Brief Summary
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria Crohns Disease a.
- •Diagnosis of Crohn s Disease as confirmed by endoscopy and histopathology b.
- •Moderately to severely active CD as defined by Clinical Disease Activity Index and Simple Endoscopic Score c.
- •Meets drug stabilization requirements Inclusion Criteria Ulcerative Colitis a.
- •Diagnosis of Ulcerative Colitis as confirmed by endoscopy and histopathology b.
- •Moderately to severely active UC as defined by a 3 component MMCS c Meets drug stabilization requirements.
Exclusion Criteria
- •Exclusion Criteria Crohns Disease a.
- •Diagnosis of indeterminate colitis b.
- •Suspected or diagnosed intra-abdominal or perianal abscess at Screening c.
- •Previous small bowel resection with combined resected length of greater than 100 cm or previous colonic resection of greater than 2 segments d.
- •CD isolated to the stomach duodenum jejunum or perianal region without colonic and or ileal involvement Exclusion Criteria Ulcerative Colitis a.
- •Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation b.
- •Current stoma or impending need for colostomy or ileostomy c.
- •Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase d.
- •Previous total proctocolectomy or subtotal colectomy.
Outcomes
Primary Outcomes
a. Assess the proportion of participants reporting treatment emergent adverse events, serious adverse events, adverse events leading to discontinuation, and markedly abnormal laboratory values
Time Frame: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
b. Assess the Proportion of Participants with Endoscopic Response as assessed by SES CD score.
Time Frame: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
c. Assess the Proportion of Participants Endoscopic Improvement as assessed by MES.
Time Frame: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
d. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.
Time Frame: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
e. Assess the Proportion of Participants with Clinical Remission by endoscopy, rectal bleeding and stool frequency
Time Frame: a. Time Frame Up to 13 weeks | b. Time Frame 13 weeks. | c. Time Frame 12 weeks | d. Time Frame 13 weeks | e. Time Frame 12 weeks
Secondary Outcomes
- a. Assess the Proportion of Participants with Clinical Remission as assessed by CDAI score.(b. Assess the Proportion of Participants with Clinical Remission by endoscopy rectal bleeding and stool frequency.)
- j. Characterize the Change in Endoscopy as assessed by SES CD.(k. Characterize the Change in Endoscopy Score as assessed by MES.)
Investigators
Dr Radhika Bobba
PSI CRO PHARMA India Private Limited