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)
Mirador Therapeutics, Inc.
Summary
This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
Description
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria-Crohn's Disease: * Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology * Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD) * Meets drug stabilization requirements Inclusion Criteria-Ulcerative Colitis: * Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology * Moderately to severely active UC as defined by a 3-component MMCS * Meets drug stabilization requirements Exclusion Criteria-Crohn's Disease: * Diagnosis of indeterminate colitis * Suspe…
Interventions
- DrugMT-501
MT-501
- DrugMT-201
MT-201
Locations (66)
- Mirador Therapeutics Selected SiteBirmingham, Alabama
- Mirador Therapeutics Selected SiteScottsdale, Arizona
- Mirador Therapeutics Selected SiteSun City, Arizona
- Mirador Therapeutics Selected SiteLittle Rock, Arkansas
- Mirador Therapeutics Selected SiteLittle Rock, Arkansas
- Mirador Therapeutics Selected SiteColorado Springs, Colorado