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REGN2477

DRUG3 trials

Sponsors

Regeneron Pharmaceuticals

Conditions

Fibrodysplasia Ossificans ProgressivaHealthy Volunteers

Phase 1

A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
CompletedNCT02870400
Regeneron PharmaceuticalsHealthy Volunteers
Start: 2016-07-31End: 2017-01-12Updated: 2017-02-20
Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men
CompletedNCT02943239
Regeneron PharmaceuticalsHealthy Volunteers
Start: 2016-12-08End: 2019-04-30Updated: 2024-08-09

Phase 2

A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
CompletedNCT03188666
Regeneron PharmaceuticalsFibrodysplasia Ossificans Progressiva
Start: 2018-02-26End: 2021-09-16Updated: 2022-12-02

Related Papers

Content Validation of the Flares Diary: A Qualitative Analysis of the Flares Experience Within the Fibrodysplasia Ossificans Progressiva (FOP) Population.
2026-03-10
GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial.
2025-05-135 citations
Comparison of PET/CT versus CT only in the assessment of new heterotopic ossification bone lesions in patients with fibrodysplasia ossificans progressiva.
2024-10-10
7390 Case Study Of New Lesion Formation In FOP Patients By 18F-NaF PET/CT Imaging
Journal of the Endocrine Society2024-10-01
Characterization of flare-ups and impact of garetosmab in adults with fibrodysplasia ossificans progressiva: a post hoc analysis of the randomized, double-blind, placebo-controlled LUMINA-1 trial
Journal of Bone and Mineral Research2024-08-314 citations
Performance of simplified methods for quantification of [18F]NaF uptake in fibrodysplasia ossificans progressiva
Frontiers in Nuclear Medicine2024-07-222 citations
The effects of garetosmab in people with fibrodysplasia ossificans progressiva (FOP): A plain language summary of the LUMINA-1 study
Future Rare Diseases2024-04-11
Study methodology and insights from the palovarotene clinical development program in fibrodysplasia ossificans progressiva.
2023-11-138 citations
THU467 Pharmacokinetics And Pharmacodynamics Of Garetosmab In Patients With Fibrodysplasia Ossificans Progressiva
Journal of the Endocrine Society2023-10-01
THU402 New Heterotopic Ossification Lesions In Patients With Fibrodysplasia Ossificans Progressiva Measured By PET/CT vs CT Only
Journal of the Endocrine Society2023-10-01
OR29-06 Flare-Ups In Patients With Fibrodysplasia Ossificans Progressiva Reduced By Garetosmab Treatment: LUMINA-1 Data
Journal of the Endocrine Society2023-10-01
Garetosmab in fibrodysplasia ossificans progressiva: a randomized, double-blind, placebo-controlled phase 2 trial
Nature Medicine2023-09-2843 citations
Garetosmab in Fibrodysplasia Ossificans Progressiva: Clinical Pharmacology Results from the Phase 2 LUMINA‐1 Trial
The Journal of Clinical Pharmacology2023-09-113 citations
Garetosmab Reduces Flare-ups in Patients With Fibrodysplasia Ossificans Progressiva
Journal of the Endocrine Society2021-05-013 citations
Pharmacokinetics and Pharmacodynamics of Garetosmab (Anti‐Activin A): Results From a First‐in‐Human Phase 1 Study
The Journal of Clinical Pharmacology2020-06-1851 citations