Trial Profile
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARgamma-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 07 Nov 2022
Price :
$35
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At a glance
- Drugs Palovarotene (Primary)
- Indications Fibrodysplasia ossificans progressiva
- Focus Registrational; Therapeutic Use
- Sponsors Clementia Pharmaceuticals
- 01 Oct 2022 Primary endpoint (Percentage of Responders at Week 6) has not been met, according to Results published in the Journal of Bone and Mineral Research.
- 01 Oct 2022 Results published in the Journal of Bone and Mineral Research
- 24 Oct 2019 According to an Ipsen media release, the Palovarotene regulatory submission to the FDA for the episodic treatment of FOP now expected in Q1 2020 as a result of the processing of additional supportive data.