NCT07113522 · Mirador Therapeutics, Inc.
A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
(ASCEND-IBD)
What this study is about
This is a Phase 2, conducted at multiple hospitals, 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 effectiveness of multiple experimental drugs.
View original scientific description
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.
Interventions
DRUG
MT-501
MT-501
DRUG
MT-201
MT-201
Primary outcome measures
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)
Time frame: 13 weeks
Endoscopic response as assessed by SES-CD score.
Assess the Proportion of Participants Endoscopic Improvement (UC)
Time frame: 12 weeks
Endoscopic improvement as assessed by MES.
Assess the Proportion of Participants with Clinical Remission (CD)
Time frame: 13 weeks
Clinical remission as assessed by CDAI score.
Assess the Proportion of Participants with Clinical Remission (UC)
Time frame: 12 weeks
Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Scottsdale, Arizona
- Sun City, Arizona
- Little Rock, Arkansas
- Colorado Springs, Colorado
- Littleton, Colorado
- Miami, Florida
- Orlando, Florida
- Palmetto Bay, Florida
- Pensacola, Florida
- Atlanta, Georgia
- Snellville, Georgia
And 31 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations