Trial · NCT05039515
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
NCT05039515, Phase 2, Terminated, Clementia Pharmaceuticals Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). Trials, record NCT05039515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05039515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
- NCT number
- NCT05039515
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 113 participants, actual
- Lead sponsor
- Clementia Pharmaceuticals Inc.
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Interventions
- IPN60130, IPN60130, Placebo
- First posted
- 2021-09-09
- Last updated
- 2026-04-24
- Other registries' IDs
- eudract:2020-002858-24
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized change in HO volume as assessed by low-dose WBCT (excluding the head) in treated participants receiving IPN60130 compared with placebo. | From baseline to 12 months | |
| Primary | Incidence of Adverse Events / Serious Adverse Events (AEs/SAE) | From baseline until the end of study (63 months) | |
| Primary | Change from baseline in clinically significant abnormal values in laboratory parameters (haematology, biochemistry, and urinalysis) | From baseline until the end of study (63 months) | 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. |
| Primary | Change from baseline in physical examination findings | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in clinically significant vital signs | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be graded by the investigator. |
| Primary | Change from baseline in clinically significant Electrocardiogram (ECG) readings | From baseline until the end of study (63 months) | Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator. |
| Secondary | Change in HO volume of new HO lesions as detected by WBCT in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Change in number of HO lesions by WBCT in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | |
| Secondary | Flare-up rate and number of flare-up days in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months | 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 |
| Secondary | The number of body regions with new HO in participants receiving IPN60130 compared with placebo recipients | From baseline up to 12 months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05039515
GET https://conductscience.org/api/trials/v1/NCT05039515/registered