NCT07113522 A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease
| NCT ID | NCT07113522 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mirador Therapeutics, Inc. |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-06-26 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07113522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07113522 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07113522 currently recruiting?
Yes, NCT07113522 is actively recruiting participants. Contact the research team at clinicaltrials@miradortx.com for enrollment information.
Where is the NCT07113522 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Sun City, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT07113522 clinical trial?
NCT07113522 is sponsored by Mirador Therapeutics, Inc.. The trial plans to enroll 140 participants.