A Phase 2 interventional study of IPN60130 and IPN60130 in Fibrodysplasia Ossificans Progressiva, sponsored by Clementia Pharmaceuticals Inc.. Terminated at 25 sites in 14 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Clementia Pharmaceuticals Inc. (part of Ipsen) · Phase 2, Interventional, and Treatment
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). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability.
This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head.
Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).
Note on Primary Completion Date and Results Disclosure:
The Primary Completion Date (PCD) reflects the date when data collection is completed for all primary outcomes, as defined in the Final Rule (42 CFR Part 11). In this study, safety outcomes are designated as primary and collected through the end of study.
Therefore the PCD has been updated to align with this definition. The interim analyses will proceed per the protocol and SAP. Results will be disclosed in line with applicable regulatory timelines.
24 studies on the registry are indexed under Myositis Ossificans; 5 are open to participants now.
This study's enrollment of 113 is above the median of 48 across 16 interventional studies indexed under Myositis Ossificans.
Browse Myositis Ossificans studies →Clementia Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
First submitted after Clementia Pharmaceuticals Inc. became part of Ipsen.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participants who have participated in a prior clinical study using another product for the treatment of FOP may be enrolled after a of at least 5 half-lives of the other investigational product. Participants with prior treatment such as, but not limited to, imatinib, isotretinoin, garetosmab, or palovarotene may be enrolled 30 days after discontinuation or after washout of at least 5 half-lives, whichever is longer.
Key Exclusion Criteria:
Participants with hematologic abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral capsule, swallowed whole or sprinkled onto food, once daily
Drug: IPN60130
Oral capsule, swallowed whole or sprinkled onto food, once daily
Drug: IPN60130
Oral capsule, swallowed whole or sprinkled onto food, once daily
Drug: Placebo
Immediate-release capsule containing high dose of the drug substance.
Also known as: Fidrisertib
Immediate-release capsule containing low dose of the drug substance.
Also known as: Fidrisertib
Placebo will be supplied as powder filled hard capsules
Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo.
Time frame: From baseline to 12 months
Incidence of Adverse Events / Serious Adverse Events (AEs/SAE)
Time frame: From baseline until the end of study (63 months)
Change from baseline in clinically significant abnormal values in laboratory parameters (haematology, biochemistry, and urinalysis)
Percentage of participants with clinically significant change in laboratory parameters (biochemistry, hematology and urinalysis) will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until the end of study (63 months)
Change from baseline in physical examination findings
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until the end of study (63 months)
Change from baseline in clinically significant vital signs
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until the end of study (63 months)
Change from baseline in clinically significant Electrocardiogram (ECG) readings
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline until the end of study (63 months)
Change in HO volume of new HO lesions as detected by WBCT in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Change in number of HO lesions by WBCT in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Flare-up rate and number of flare-up days in participants receiving IPN60130 compared with placebo recipients
The rate and the number of flare-up days, the flare-up being confirmed by the Investigator, will be compared between participants treated with IPN60130 and those treated with Placebo at Month 12
Time frame: From baseline up to 12 months
The number of body regions with new HO in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Change in pain intensity
Assessed in participants ≥13 years old with the Numeric pain rating scale (NRS) and in participants \<13 years old with Wong Baker Faces Pain Scale (FPS)
Time frame: From baseline up to 12 months
The proportion of participants with any new HO in participants receiving IPN60130 compared with placebo recipients
Time frame: From baseline up to 12 months
Change from baseline in HO volume as detected by WBCT in participants receiving IPN60130 compared with placebo recipients and with participants receiving the standard of care in the Natural history study (NHS)
Time frame: From baseline up to 60 months
Change from baseline in Cumulative Analogue Joint Involvement Scale for FOP (CAJIS) by treatment arm compared with placebo recipients and participants receiving the standard of care in the NHS across all available timepoints
Time frame: From baseline up to 60 months
Change in the FOP Physical Function Questionnaire (FOP-PFQ) by treatment arm compared with placebo recipients and participants receiving the standard of care in the NHS from baseline across all available timepoints
Time frame: From baseline up to 60 months
Pharmacokinetic (PK) parameter: Cmax of IPN60130
Cmax is defined as the maximum observed concentration of IPN60130
Time frame: From baseline up to Month 24
PK parameter: AUC of IPN60130
AUC is defined as the concentration of drug over time.
Time frame: Every 6 months up to Month 24
PK parameter: Ctrough of IPN60130
Ctrough is defined as the plasma concentration at the end of the dosing interval.
Time frame: Every 6 months up to Month 24
PK parameter: Cmin of IPN60130
Cmin is defined as the minimum observed concentration of IPN60130
Time frame: Every 6 months up to Month 24
Assessment of the exposure-response relationship
The exposure-response relationship will be assessed by modelling using relevant efficacy and safety parameters
Time frame: From baseline up to 60 months
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Access criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Data sharing details ↗ · www.ipsen.com
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Mar 2026, 51 months.
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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Clementia Pharmaceuticals Inc. →