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Clinical trial of itolizumab in combination with corticosteroids for the initial treatment of acute graft-versus-recipient disease.
THE MAIN OBJECTIVE OF THIS STUDY IS TO TEST THE EFFICACY AND SAFETY (BENEFITS AND RISKS) OF ITOLIZUMAB, WHEN ADDED TO CORTICOSTEROIDS, AS A TREATMENT FOR YOUR CRID. WE WANT TO FIND OUT WHAT EFFECTS, GOOD OR BAD, ITOLIZUMAB HAS ON EACH PATIENT AND THEIR CRID. WE ALSO WANT TO MEASURE THE LEVELS OF ITOLIZUMAB IN THEIR BLOOD OVER TIME. YOUR VOLUNTARY PARTICIPATION IN THIS RESEARCH STUDY MAY HELP DETERMINE WHETHER ITOLIZUMAB IS SAFE WHEN GIVEN TO PARTICIPANTS WITH CRID (ACUTE GRAFT-VERSUS-RECIPIENT DISEASE).
Technical Summary
- PHASE III, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-MASKED, MULTICENTER STUDY OF ITOLIZUMAB IN COMBINATION WITH CORTICOSTEROIDS FOR THE INITIAL TREATMENT OF ACUTE GRAFT-VERSUS-RECIPIENT DISEASE. IMMUNOTHERAPY
- Code EudraCT: 2021-004529-57
- Protocol number: EQ-100-02
- Promoter: Equillium, Inc.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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