Tests several medicines in adults with active Crohn's disease or ulcerative colitis
Tests several medicines for active Crohn's disease or ulcerative colitis in adults.
Key facts
- Who runs it
- Mirador Therapeutics Inc.
- Where
- Bonheiden, Edegem, and Leuven, BelgiumSee the 3 sitesAlso in 7 other countries, 37 sites
- Trial code
- Registry title
- A Phase 2 Platform Study to Evaluate Therapies for Inflammatory Bowel Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 54 people, planned
- Started
- 27 May 2026
- Expected to end
- 7 May 2027
- Type of study
- Interventional
- Record updated
- 20 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with moderately to severely active Crohn's disease or ulcerative colitis. They must not have responded well to earlier treatment, or could not tolerate it.
- Age
- 18 to 80 years
- Sex
- All sexes can join. Women who can have children need a negative pregnancy test at screening.
- Disease stage
- Documented Crohn's disease (CD) or ulcerative colitis (UC), moderately to severely active. For CD, this is shown by CDAI and by SES-CD from a central reading. Participants must meet drug stabilization requirements.
- Earlier treatment
- Not enough response, or could not tolerate, corticosteroids, immunosuppressants and/or an approved advanced therapy for UC or CD.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Serious bacterial infection in the 3 months before screening, or stool positive for enteric pathogens or C. difficile
- Cancer in the 5 years before screening (other than non-melanoma skin cancers removed locally)
- Planned or expected surgery (other than minor outpatient procedures)
- Concomitant primary sclerosing cholangitis, or at risk for tuberculosis (TB)
The registry criteria, word for word
Show all 34 criteriaShow less
Who can take part
- ≥ 18 to ≤ 80 years old
- UC: Moderately to severely active UC
- UC: Participants must meet drug stabilization requirements
- Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA
- Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD
- Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA
- CD: Documented diagnosis of CD
- CD: Moderately to severely active CD as defined by CDAI
- CD: SES-CD (per central reading) consistent with moderate to severely active CD
- CD: Participants must meet drug stabilization requirements
- UC: Documented diagnosis of UC
Who cannot take part
- Participants with any serious bacterial infection within 3 months prior to Screening
- CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
- UC patients: Previous total proctocolectomy or subtotal colectomy
- Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures
- Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study
- Participants with concomitant primary sclerosing cholangitis
- Stool positive for Clostridioides difficile (C. difficile) infection
- Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness
- Allergy to intervention or any of the excipients
- UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation
- Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator
- Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection)
- Participants at risk for tuberculosis (TB)
- Clinically significantly abnormal laboratory values
- Women who are pregnant or breastfeeding
- Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens
- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study
- CD patients: Diagnosis of indeterminate colitis
- CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch
- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed
Where in Belgium
Also in 7 other countries, 37 sites
- ImeldaBonheiden, BelgiumNot yet recruiting
- University Of AntwerpEdegem, BelgiumNot yet recruiting
- UZ LeuvenLeuven, BelgiumNot yet recruiting
About the trial
What the trial wants to find out
Evaluate safety and tolerability following Induction Phase (IP); Prospective Observer-Blinded Endpoint ISAs: Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of IP; Randomized Placebo-Controlled ISAs: Assess the proportion of participants with clinical remission at end of IP.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests several medicines in adults with active Crohn's disease or ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 20 July 2026