272. Fibrodysplasia ossificans progressiva
23 clinical trials,   21 drugs   (DrugBank: 4 drugs),   10 drug target genes,   87 drug target pathways

Searched query = "Fibrodysplasia ossificans progressiva", "FOP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04577820
(ClinicalTrials.gov)
November 5, 202030/9/2020Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)Evaluation of Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans ProgressivaFibrodyplasia Ossificans Progressiva (FOP);Heterotopic Ossification (HO)Drug: garetosmabRegeneron PharmaceuticalsNULLNot yet recruiting18 Years60 YearsAll6Phase 3NULL
2NCT04307953
(ClinicalTrials.gov)
August 5, 202011/3/2020Saracatinib Trial TO Prevent FOPSaracatinib Trial TO Prevent FOPFibrodysplasia Ossificans ProgressivaDrug: AZD0530 Difumarate;Drug: Matching placeboVU University Medical CenterRoyal National Orthopaedic Hospital NHS Trust;Klinikum Garmisch-Patenkirchen;University of Oxford;Brigham and Women's Hospital;AstraZeneca;Innovative Medicines InitiativeRecruiting18 Years65 YearsAll20Phase 2Germany;Netherlands;United Kingdom
3EUCTR2019-003324-20-NL
(EUCTR)
08/01/202016/10/2019A clinical trial to judge the safety, tolerability and effects on abnormal bone formation of reseach medication AZD 0530 (sarcatinib) in patients with FOPSaracatinib trial TO Prevent FOP - STOPFOP Fibrodyplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Saracatinib
Product Code: AZD0530
INN or Proposed INN: Saracatinib
Other descriptive name: SARACATINIB DIFUMARATE
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Netherlands
4EUCTR2016-005035-33-ES
(EUCTR)
17/01/201922/01/2019A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans ProgressivaA randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: REGN2477
Product Code: REGN2477
INN or Proposed INN: N/A
Other descriptive name: REGN2477
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;France;Mexico;Canada;Poland;Spain;Netherlands;Colombia;United Kingdom;Italy
5EUCTR2017-002541-29-NL
(EUCTR)
16/07/201806/02/2018 A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Clementia Pharmaceuticals IncNULLNA Female: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-005035-33-NL
(EUCTR)
05/03/201804/07/2017A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans ProgressivaA randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2France;United States;Argentina;Spain;Brazil;Netherlands;Italy;United Kingdom
7NCT03188666
(ClinicalTrials.gov)
February 26, 201813/6/2017A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans ProgressivaA Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans ProgressivaFibrodysplasia Ossificans ProgressivaDrug: REGN2477;Drug: Matching placeboRegeneron PharmaceuticalsNULLActive, not recruiting18 Years60 YearsAll44Phase 2United States;Canada;France;Italy;Netherlands;Poland;Spain;United Kingdom;Colombia
8EUCTR2016-005035-33-IT
(EUCTR)
15/12/201708/03/2018A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans ProgressivaA randomized, placebo-controlled study to assess the safety, tolerability,pharmacokinetics, and effects on heterotopic bone formation of REGN2477in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: REGN2477
Product Code: REGN2477
Other descriptive name: REGN2477
REGENERON PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;United States;Argentina;Brazil;Netherlands;United Kingdom;Italy
9EUCTR2017-002541-29-GB
(EUCTR)
14/12/201711/09/2017 A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
107Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden
10EUCTR2017-002541-29-SE
(EUCTR)
05/12/201720/09/2017 A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
107Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03312634
(ClinicalTrials.gov)
November 28, 20179/10/2017An Efficacy and Safety Study of Palovarotene for the Treatment of FOPA Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: PalovaroteneClementia Pharmaceuticals Inc.NULLActive, not recruiting4 YearsN/AAll110Phase 3United States;Argentina;Australia;Brazil;Canada;France;Italy;Japan;Spain;Sweden;United Kingdom
12EUCTR2017-002541-29-ES
(EUCTR)
14/11/201728/09/2017A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP)A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: PALOVAROTENE
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
13EUCTR2016-005035-33-GB
(EUCTR)
15/08/201722/05/2017A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans ProgressivaA randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: REGN2477
Product Code: REGN2477
INN or Proposed INN: N/A
Other descriptive name: REGN2477
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;France;Mexico;Canada;Spain;Poland;Netherlands;Colombia;Italy;United Kingdom
14NCT02979769
(ClinicalTrials.gov)
November 28, 201623/11/2016An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in FranceA Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: Palovarotene dose level 1;Drug: Palovarotene dose level 2Clementia Pharmaceuticals Inc.NULLActive, not recruiting6 Years65 YearsAll9Phase 2France
15NCT02521792
(ClinicalTrials.gov)
December 7, 20156/8/2015In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) SubjectsA Phase 2, In-Home, Safety and Efficacy Evaluation of Episodic Administration of Open-Label Palovarotene in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: PalovaroteneClementia Pharmaceuticals Inc.NULLTerminated6 Years65 YearsAll6Phase 2United States;France;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-002496-28-GB
(EUCTR)
13/11/201504/09/2015Extension Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with 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) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years.
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Palovarotene
Product Code: Palovarotene
INN or Proposed INN: Palovarotene
Other descriptive name: Palovarotene
Clementia Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Argentina;Australia;United Kingdom
17EUCTR2014-001453-17-GB
(EUCTR)
07/07/201525/02/2015The Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva.A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with 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) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years.
MedDRA version: 18.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Palovarotene
Product Code: Palovarotene
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: Palovarotene
Product Code: Palovarotene
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Argentina;United Kingdom
18NCT02279095
(ClinicalTrials.gov)
October 27, 201426/10/2014An Open-Label Extension Study of Palovarotene Treatment in FOPA Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR? Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: Palovarotene dose level 1;Drug: Palovarotene dose level 2;Drug: Palovarotene dose level 3;Drug: Palovarotene dose level 4Clementia Pharmaceuticals Inc.NULLActive, not recruiting6 Years65 YearsAll54Phase 2United States;Argentina;Australia;France;United Kingdom
19NCT02190747
(ClinicalTrials.gov)
July 201413/7/2014An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP SubjectsA Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: Palovarotene;Drug: PlaceboClementia Pharmaceuticals Inc.NULLCompleted6 YearsN/AAll40Phase 2United States;France;United Kingdom
20JPRN-UMIN000019348
2010/07/0114/10/2015Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP) fibrodysplasia ossificans progressivaoral administration of perhexiline maleate for one yearNagoya University Graduate School of MedicineNULLComplete: follow-up complete15years-old65years-oldMale and Female5Phase 1;Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-002526-36-FR
(EUCTR)
04/07/2016Study of an Investigational Drug, Palovarotene, in the prevention of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)A Phase 2, Open-Label, Efficacy and Safety Study of an RAR?-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with 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) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years.
MedDRA version: 19.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Clementia Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
17Phase 2France
22EUCTR2017-002541-29-FR
(EUCTR)
20/10/2017 A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Clementia Pharmaceuticals IncNULLNA Female: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
23EUCTR2017-002541-29-DE
(EUCTR)
29/09/2017A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP)A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial Fibrodysplasia Ossificans Progressiva (FOP)
MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: PALOVAROTENE - 1mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 1.5mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 2 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 2.5 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 3 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 4 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 5 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 10 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden