Ipsen: Myositis Ossificans trials

The registry lists 10 Myositis Ossificans studies with Ipsen as lead sponsor. 1 are open to participants now and 5 have results posted.

Phase 1 1Phase 2 4Phase 3 2No phase 3(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)RecruitingNCT06089616
• A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.CompletedNCT05027802Phase 3Results posted
• An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.CompletedNCT03312634Phase 3Results posted
• In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) SubjectsTerminatedNCT02521792Phase 2Results posted
• An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)CompletedNCT02279095Phase 2Results posted
• An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP SubjectsCompletedNCT02190747Phase 2Results posted
• A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).TerminatedNCT05039515Phase 2
• Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult SubjectsCompletedNCT04829773Phase 1
• An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.CompletedNCT04665323
• A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)CompletedNCT02322255