Orismilast for the treatment of moderate to severe ulcerative colitis
Key facts
- Where
- Herlev és Hvidovre, DániaSee the 2 sites
- Phase
- 2. fázis
Where in Dánia
- Herlev HospitalHerlev, DániaNo longer taking part
- Hvidovre HospitalHvidovre, DániaNo longer taking part
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?
Trial details
- Who runs it
- Hvidovre Hospital
- Trial code
- EU 2022-502763-37-02
- Record updated
- 2023. december 14.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Currently treated with biologic therapy; Currently treated with steroids; 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; Require hospitalization; HADS score ≥15 at baseline in the depression subscore; Clinical signs suggestive of fulminant colitis or toxic megacolon; Failed on >1 anti-body treatment.