A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn's Disease
• Interventions: Drug: MT-501

• Registration Number: NCT07113522
• Lead Sponsor: Mirador Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2025-06-26
• Study First Submitted: 2025-07-15
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2026-07-31
• Study Completion: 2027-05-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Specific Appendix- Crohn's Disease	MT-501	Participants will receive MT-501
Intervention Specific Appendix- Ulcerative Colitis	MT-501	Participants will receive MT-501

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
Assess the Proportion of Participants with Clinical Remission (CD)	13 weeks	CD: 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 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 Endoscopy Score (UC)	12 weeks	Endoscopy score as assessed by MES.
Characterize the Change in Histology Score (CD)	13 weeks	Histology as assessed by GHAS and RHI.
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

Trial Locations

Locations (1)

Mirador Therapeutics Selected Site; 🇺🇸 Milwaukee, Wisconsin, United States