Trial · NCT05394116
A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
NCT05394116, Phase 3, Active not recruiting, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP). Trials, record NCT05394116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05394116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP)
- NCT number
- NCT05394116
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Fibrodysplasia Ossificans Progressiva
- Interventions
- Garetosmab, Placebo
- First posted
- 2022-05-27
- Last updated
- 2026-07-17
- Other registries' IDs
- eudract:2022-000880-40
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of new HO lesions | At Week 56 | |
| Primary | Incidence and severity of treatment-emergent adverse events of special interest (AESIs) | Baseline to Week 56 | |
| Secondary | Number of clinician-assessed flare-ups | Through Weeks 28, 56 and 84 | Investigator assess flare-up events according to his/her medical judgment. A FOP flare-up is characterized as episodic, painful inflammatory soft tissue swelling. Week 84 Only for Patients on Extended Treatment |
| Secondary | Occurrence of new HO lesions | At Weeks 28, 56 and 84 | Reported as Yes/No Week 84 Only for Patients on Extended Treatment |
| Secondary | Total volume of new HO lesions | At Weeks 28, 56 and 84 | Week 84 Only for Patients on Extended Treatment |
| Secondary | Occurrence of patient-reported flare-ups | Through Weeks 28 and 56 | Reported as Yes/No |
| Secondary | Number of new HO lesions | At week 28 and 84 | Week 84 Only for Patients on Extended Treatment |
| Secondary | Occurrence of clinician-assessed flare-ups | Through Weeks 28, 56 and 84 | Reported as Yes/No Week 84 Only for Patients on Extended Treatment |
| Secondary | Number of patient-reported flare-ups | Through Weeks 28 and 56 | Flare-up is defined as two or more of the following: pain, swelling, joint stiffness, or decrease in movement. The FOP flare-up dairy is a questionnaire and is self-completed by the participant daily. |
| Secondary | Change in joint function assessment by physician using cumulative analog joint involvement scale (CAJIS) | Baseline to Weeks 28 and 56 | CAJIS is a clinician assessment of 15 major joints; each major joint rated normal unaffected (0), affected (1), or completely functionally ankylosed (2). The total score ranges from 0 to 30 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42805227 | DERIVED |
Source PubMed
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/NCT05394116
GET https://conductscience.org/api/trials/v1/NCT05394116/registered