BridgeMD
A Phase 2 Platform Study to Evaluate Therapies for Inflammatory Bowel Disease
EU CTIS ID: 2025-522001-38-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 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.
You likely can't join if
- Women who are pregnant or breastfeeding.
- Participants with any serious bacterial infection within 3 months prior to Screening.
- Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.
- Stool positive for Clostridioides difficile (C. difficile) infection.
- Clinically significantly abnormal laboratory values.
- Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
See the full eligibility criteria
- ≥ 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.
- Women who are pregnant or breastfeeding.
- Participants with any serious bacterial infection within 3 months prior to Screening.
- Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.
- Stool positive for Clostridioides difficile (C. difficile) infection.
- Clinically significantly abnormal laboratory values.
- Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.
- Allergy to intervention or any of the excipients.
- 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: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.
- CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.
- UC patients: Previous total proctocolectomy or subtotal colectomy.
- Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.
- Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.
- Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Israel
- Brazil
- India
- Australia
- Ukraine
- Serbia
- Moldova, Republic of
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Israel; Brazil; India; Australia; Ukraine and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.