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A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

ConditionsInflammatory Bowel Disease (IBD)Ulcerative Colitis (UC)Crohn's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMirador Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Diagnosis of Ulcerative Colitis (UC), as confirmed by endoscopy and histopathology

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • MT-501

    Drug

    MT-501

  • MT-201

    Drug

    MT-201

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: Intervention Specific Appendix- Crohn's DiseaseExperimental treatment 1 intervention
Group B: Intervention Specific Appendix- Ulcerative ColitisExperimental treatment 1 intervention
Group C: Intervention Specific Appendix- Crohn's Disease with Standard of CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Assess the Proportion of Participants with Endoscopic Response (CD)

Endoscopic response as assessed by SES-CD score.

Time frame
13 weeks
3

Assess the Proportion of Participants Endoscopic Improvement (UC)

Endoscopic improvement as assessed by MES.

Time frame
12 weeks
4

Assess the Proportion of Participants with Clinical Remission (CD)

Clinical remission as assessed by CDAI score.

Time frame
13 weeks

Secondary outcomes

1

Assess the Proportion of Participants with Clinical Remission (CD)

CD: Clinical remission as assessed by CDAI score.

Time frame
13 weeks
2

Assess the Proportion of Participants with Clinical Remission (UC)

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

Time frame
12 weeks
3

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

Symptomatic remission as assessed by patient reported outcomes.

Time frame
Up to 13 weeks
4

Assess the Proportion of Participants with Clinical Response (CD)

CD: Clinical response as assessed by CDAI score.

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mirador Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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