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Orismilast for the treatment of moderate to severe ulcerative colitis
EU CTIS ID: 2022-502763-37-02
What this study is testing
To explore evidence of efficacy of orismilast in the oral treatment of patients with UC when dosed twice daily for up to 12 weeks in a clinically relevant endpoint.
- 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
- Male or female adult patients, 18 years of age or older. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 that result in a low failure rate of less than 1% per year when used consistently and correctly, for the duration of the trial and 16 weeks after last administration. A list of contraception methods meeting these criteria is provided in the patient information and Appendix E
- Diagnosis of ulcerative colitis with a minimum of 3 months of disease history
- Mayo endoscopic subscore of 2 or 3 at screening
- Current treatment regimen of 5-ASA (e.g., mesalazine and sulfazalazine), mercaptopurine (6-MP), methotrexate (MTX), or azathioprine
- Currently on stable unchanged medication regimen for the last 3 months or more, but now requiring intensification (dose-increase or additional therapy)
- Signed and dated written informed consent in accordance with GCP and local legislation prior to the start of any screening procedures
You likely can't join if
- Require hospitalization
- HADS score ≥15 at baseline in the depression subscore
- Any medical or psychiatric condition that, in the Investigator’s opinion, would preclude the patient from adhering to the protocol, completing the study per-protocol, and/or would place the patient at unacceptable risk while receiving the investigational therapy
- Clinical signs suggestive of fulminant colitis or toxic megacolon
- Currently treated with biologic therapy
- Currently treated with steroids
See the full eligibility criteria
- Male or female adult patients, 18 years of age or older. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 that result in a low failure rate of less than 1% per year when used consistently and correctly, for the duration of the trial and 16 weeks after last administration. A list of contraception methods meeting these criteria is provided in the patient information and Appendix E
- Diagnosis of ulcerative colitis with a minimum of 3 months of disease history
- Mayo endoscopic subscore of 2 or 3 at screening
- Current treatment regimen of 5-ASA (e.g., mesalazine and sulfazalazine), mercaptopurine (6-MP), methotrexate (MTX), or azathioprine
- Currently on stable unchanged medication regimen for the last 3 months or more, but now requiring intensification (dose-increase or additional therapy)
- Signed and dated written informed consent in accordance with GCP and local legislation prior to the start of any screening procedures
- Require hospitalization
- HADS score ≥15 at baseline in the depression subscore
- Any medical or psychiatric condition that, in the Investigator’s opinion, would preclude the patient from adhering to the protocol, completing the study per-protocol, and/or would place the patient at unacceptable risk while receiving the investigational therapy
- Clinical signs suggestive of fulminant colitis or toxic megacolon
- Currently treated with biologic therapy
- Currently treated with steroids
- Failed on >1 anti-body treatment
- Treated with any therapies and systemic treatments as described in Table 3, “Prohibited Prior Therapies and Treatments” that do not comply with the indicated washout interval
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial. Women who stop nursing before the study drug administration do not need to be excluded from participating
- Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to screening
- History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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.