Trial · NCT05090891
To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
NCT05090891, Phase 2, Recruiting, Incyte Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva. Trials, record NCT05090891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05090891
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
- NCT number
- NCT05090891
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 98 participants, estimated
- Lead sponsor
- Incyte Corporation
- Conditions
- Fibrodysplasia Ossificans Progressiva (FOP)
- Interventions
- INCB000928, Placebo
- First posted
- 2021-10-25
- Last updated
- 2026-10-22
- Other registries' IDs
- eudract:2021-002286-17
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double Blind Period: Occurrence of new heterotopic ossification (HO) lesions from baseline | Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. |
| Secondary | Double Blind Period: Number of new HO lesions from baseline | Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. |
| Secondary | Double Blind Period: Total volume of new HO lesions from baseline | Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. |
| Secondary | Double Blind Period: Change in the total volume of all HO lesions from baseline | Week 24 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) compared to baseline during the double-blind period. |
| Secondary | Double Blind Period: Number of new flares from baseline | Week 24 | Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT). |
| Secondary | Number of Participants with Treatment Emergent Adverse Events (TEAE) | Up to 316 weeks | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
| Secondary | Open-Label Extension: Occurrence of new HO lesions from Week 24 | Week 48 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. |
| Secondary | Open-Label Extension: Number of new HO lesions from Week 24 | Week 48 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. |
| Secondary | Open-Label Extension: Total volume of new HO lesions from Week 24 | Week 48 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. |
| Secondary | Open-Label Extension: Change in the total volume of all HO lesions from Week 24 | Week 48 | HO will be assessed by low dose whole-body computed tomography (WBCT) (excluding the head) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 |
|---|---|
| 41360500 | 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/NCT05090891
GET https://conductscience.org/api/trials/v1/NCT05090891/registered