Clinical trials: FOP
Fibrodysplasia Ossificans Progressiva
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO).
- Trial name
- FALKON (NCT05039515)
- Testing
- IPN60130
- Where
- 25 sites in United States, Argentina and 12 more
- Volunteers
- 113 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva (FOP)
An Expanded Access Program of Garetosmab in Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
The objective of this Expanded Access Program (EAP) is to provide garetosmab to adult patients with Fibrodysplasia Ossificans Progressiva (FOP), including patients who have completed the double-blind treatment period of the…
- Trial name
- NCT07301450
- Testing
- Garetosmab
- Sponsor
- Regeneron Pharmaceuticals
Fibrodysplasia Ossificans Progressiva (FOP)
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.
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP.
- Trial name
- PIVOINE (NCT05027802)
- Testing
- Palovarotene
- Where
- 13 sites in United States, Argentina and 8 more
- Volunteers
- 61 people
- Sponsor
- Ipsen
Fibrodyplasia Ossificans Progressiva (FOP), Heterotopic Ossification (HO)
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
The primary safety objective of the study is to assess the safety and tolerability of garetosmab in Japanese male and female adult patients with FOP.
- Trial name
- NCT04577820
- Testing
- garetosmab
- Sponsor
- Regeneron Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue…
- Trial name
- NCT02279095
- Testing
- Palovarotene dose level 1, Palovarotene dose level 2, Palovarotene dose level 3
- Where
- 8 sites in United States, Argentina and 3 more
- Volunteers
- 58 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
- Trial name
- NCT04818398
- Testing
- DS-6016a
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Renal Impairment, Hemodialysis
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.
- Trial name
- NCT05099445
- Testing
- INCB000928
- Where
- 5 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Fibrodysplasia Ossificans Progressiva, FOP
A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)
This study is researching an experimental drug called garetosmab, referred to as "study drug". The study is focused on children and adolescent participants with FOP.
- Trial name
- OPTIMA-2 (NCT07559513)
- Testing
- garetosmab
- Volunteers
- 18 people
- Sponsor
- Regeneron Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
The FOP burden of illness (BoI) survey aims to assess the impact of the burden of FOP on patients and their families. The study is being conducted online and available for residents in Argentina, Brazil, Canada, France, Germany…
- Trial name
- NCT04665323
- Where
- United States
- Volunteers
- 411 people
- Sponsor
- Ipsen
Fibrodysplasia Ossificans Progressiva
Urine Sample Collection From FOP Patients
The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the…
- Trial name
- FOP (NCT02066324)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02322255
- Where
- 7 sites in United States, Argentina and 4 more
- Volunteers
- 114 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP). FOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally…
- Trial name
- FOPal (NCT06089616)
- Where
- 5 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- Ipsen
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.
FOP
Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian subjects aged 18 to 55 years.
- Trial name
- NCT04829786
- Testing
- palovarotene low-dose, palovarotene high-dose
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP).
- Trial name
- ANDECAL (NCT06508021)
- Testing
- Andecaliximab
- Where
- 3 sites in United States
- Volunteers
- 92 people
- Sponsor
- Ashibio Inc
Fibrodysplasia Ossificans Progressiva
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 Subjects
Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of…
- Trial name
- NCT04829773
- Testing
- Palovarotene, midazolam
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva
A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3).
- Trial name
- LUMINA-1 (NCT03188666)
- Testing
- REGN2477
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 44 people
- Sponsor
- Regeneron Pharmaceuticals
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to…
- Trial name
- MOVE (NCT03312634)
- Testing
- Palovarotene
- Where
- 16 sites in United States, Argentina and 9 more
- Volunteers
- 107 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Fibrodysplasia Ossificans Progressiva (FOP)
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia…
- Trial name
- Progress (NCT05090891)
- Testing
- INCB000928
- Where
- 24 sites in United States, Argentina and 15 more
- Volunteers
- 98 people
- Sponsor
- Incyte Corporation