Trial · NCT04577820
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
NCT04577820, Phase 3, Withdrawn, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP). Trials, record NCT04577820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04577820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)
- NCT number
- NCT04577820
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Fibrodyplasia Ossificans Progressiva (FOP), Heterotopic Ossification (HO)
- Interventions
- garetosmab
- First posted
- 2020-10-08
- Last updated
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of treatment-emergent adverse event (TEAEs) | Through week 28 | |
| Primary | Number of new HO lesions as assessed by CT | At week 28 | |
| Secondary | Total volume of new HO lesions as assessed by CT | At week 28 | |
| Secondary | Number of new HO lesions as assessed by positron emission tomography (PET) | At week 28 | |
| Secondary | Total lesion activity in new HO lesions as assessed by PET | At week 28 | |
| Secondary | Percent of patients with new HO lesions as assessed by CT | At week 28 | |
| Secondary | Percent of patients with new HO lesions as assessed by PET | At week 28 | |
| Secondary | Percent of patients with investigator-assessed flare-ups | Baseline to week 28 | |
| Secondary | Percent of patients with investigator-assessed flare-ups | Baseline to week 56 | |
| Secondary | Percent of patients with flare-ups assessed by patient e-diary | Baseline to week 28 |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 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/NCT04577820
GET https://conductscience.org/api/trials/v1/NCT04577820/registered?page=2