NCT07113522|RecruitingPhase 2DMCFDA Drug

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

ASCEND-IBD

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.ClinicalTrials.gov

Compare

1 other identifier

MT-100-201

Study Type

interventional

Target

140

Locations

5 countries

Sites

Timeline

RegisteredAug 2025

StartedJun 2025

CompletionFeb 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P75+ for phase_2

Timeline

21mo left

Started Jun 2025

Geographic Reach

5 countries

66 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Progress35%

Jun 2025Feb 2028

Study Start

First participant enrolled

June 26, 2025

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed

24 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

July 15, 2025

Last Update Submit

March 10, 2026

Conditions

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

Keywords

Inflammatory Bowel DiseasesASCEND-IBDUlcerative ColitisUCCDCrohn's Disease

Outcome Measures

Primary Outcomes (5)

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)
Endoscopic response as assessed by SES-CD score.
13 weeks
Assess the Proportion of Participants Endoscopic Improvement (UC)
Endoscopic improvement as assessed by MES.
12 weeks
Assess the Proportion of Participants with Clinical Remission (CD)
Clinical remission as assessed by CDAI score.
13 weeks
Assess the Proportion of Participants with Clinical Remission (UC)
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
12 weeks

Secondary Outcomes (15)

Assess the Proportion of Participants with Clinical Remission (CD)
13 weeks
Assess the Proportion of Participants with Clinical Remission (UC)
12 weeks
Assess the Proportion of Participants with Symptomatic Remission (CD and UC)
Up to 13 weeks
Assess the Proportion of Participants with Clinical Response (CD)
13 weeks
Assess the Proportion of Participants with Clinical Response (UC)
12 weeks
+10 more secondary outcomes

Study Arms (3)

Intervention Specific Appendix- Crohn's Disease

EXPERIMENTAL

Participants will receive MT-501 Tablets

Drug: MT-501

Intervention Specific Appendix- Ulcerative Colitis

EXPERIMENTAL

Participants will receive MT-501Tablets

Drug: MT-501

Intervention Specific Appendix- Crohn's Disease with Standard of Care

EXPERIMENTAL

Participants will receive multiple intravenous doses of MT-201 with standard of care

Drug: MT-201

Interventions

MT-501DRUG

MT-501

Intervention Specific Appendix- Crohn's DiseaseIntervention Specific Appendix- Ulcerative Colitis

MT-201DRUG

MT-201

Intervention Specific Appendix- Crohn's Disease with Standard of Care

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
Moderately to severely active UC as defined by a 3-component MMCS
Meets drug stabilization requirements

You may not qualify if:

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
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

Contact the study team to confirm eligibility.