A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

Phase 2RecruitingNCT07113522

Mirador Therapeutics, Inc.140 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Inflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn's Disease

Interventions

MT-501DRUG

MT-501

MT-201DRUG

MT-201

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 Exclusion Criteria-Ulcerative Colitis: * Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation * Current stoma or impending need for colostomy or ileostomy * Received IV corticosteroids within 14 days prior to Screening or during the Screening Phase * Previous total proctocolectomy or subtotal colectomy

Locations (66)

Outcomes

Primary Outcomes

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

Time frame: Up to 13 weeks

Assess the Proportion of Participants with Endoscopic Response (CD)

Endoscopic response as assessed by SES-CD score.

Time frame: 13 weeks

Assess the Proportion of Participants Endoscopic Improvement (UC)

Endoscopic improvement as assessed by MES.

Time frame: 12 weeks

Assess the Proportion of Participants with Clinical Remission (CD)

Clinical remission as assessed by CDAI score.

Time frame: 13 weeks

Assess the Proportion of Participants with Clinical Remission (UC)

Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.

Time frame: 12 weeks

Secondary Outcomes

Assess the Proportion of Participants with Clinical Remission (CD)

CD: Clinical remission as assessed by CDAI score.

Time frame: 13 weeks

Assess the Proportion of Participants with Clinical Remission (UC)

Clinical remission as assessed by endoscopy, rectal bleeding, and stool frequency.

Time frame: 12 weeks

Assess the Proportion of Participants with Symptomatic Remission (CD and UC)

Central Contacts

ASCEND-IBD Trial Center

CONTACT

844-206-4980 clinicaltrials@miradortx.com

Data from ClinicalTrials.gov

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