Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn's Disease
Conditions
Keywords
Inflammatory Bowel Diseases, ASCEND-IBD, Ulcerative Colitis, UC, CD, Crohn's Disease
Brief 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.
Detailed 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.
Sponsors
Mirador Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Prospective Observer-Blinded Endpoint
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 * Suspected or diagnosed intra-abdominal or perianal abscess at Screening * Previous small bowel resection with combined resected length of \> 100 cm or previous colonic resection of \> 2 segments * CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Proportion of Participants with Endoscopic Response (CD) | 13 weeks | Endoscopic response as assessed by SES-CD score. |
| Assess the Proportion of Participants Endoscopic Improvement (UC) | 12 weeks | Endoscopic improvement as assessed by MES. |
| Assess the Proportion of Participants with Clinical Remission (CD) | 13 weeks | Clinical remission as assessed by CDAI score. |
| Assess the Proportion of Participants with Clinical Remission (UC) | 12 weeks | Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency. |
| Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values | Up to 13 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Proportion of Participants with Clinical Remission (UC) | 12 weeks | Clinical remission as assessed by endoscopy, rectal bleeding, and stool frequency. |
| Assess the Proportion of Participants with Symptomatic Remission (CD and UC) | Up to 13 weeks | Symptomatic remission as assessed by patient reported outcomes. |
| Assess the Proportion of Participants with Clinical Response (CD) | 13 weeks | CD: Clinical response as assessed by CDAI score. |
| Assess the Proportion of Participants with Clinical Response (UC) | 12 weeks | UC: Clinical response as assessed by MMCS. |
| Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only) | 13 weeks | Endoscopy as assessed by SES-CD and clinical response as assessed by CDAI score. |
| Assess the Proportion of Participants with Histologic Response (UC Only) | 12 weeks | Histologic response as assessed by the RHI. |
| Assess the Proportion of Participants with Histologic Remission (UC only) | 12 weeks | Histologic remission as assessed by the RHI. |
| Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only) | 12 weeks | Histologic-endoscopic mucosal improvement as assessed by the Geboes score and MES. |
| Characterize the Change in Endoscopy Score (CD) | 13 weeks | CD: Endoscopy score as assessed by SES-CD. |
| Characterize the Change in Histology Score (CD) | 13 weeks | Histology as assessed by GHAS and RHI. |
| Characterize the Change in Endoscopy Score (UC) | 12 weeks | Endoscopy score as assessed by MES. |
| Characterize the Change in Histology Score (UC) | 12 weeks | Histology as assessed by Geobes, RHI and NHI |
| Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug | Up to 13 weeks | — |
| Assess immunogenicity | 13 weeks | — |
| Assess the Proportion of Participants with Clinical Remission (CD) | 13 weeks | CD: Clinical remission as assessed by CDAI score. |
Countries
Canada, Georgia, Moldova, Ukraine, United States
Contacts
CONTACTASCEND-IBD Trial Center
Outcome results
None listed