Trial · NCT05090891
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Open-Label Extension: Number of new flares from Week 24 | Week 48 | Based on Fibrodysplasia Ossificans Progressiva - Patient RepOrted syMPtoms Tool (FOP-PROMPT) from Week 24 to Week 48 compared to baseline to Week 24 in participants randomized to placebo during the DB period. |
| Secondary | Pharmacokinetics Parameter: Cmax of INCB000928 | Baseline, Weeks 12, 24, 48 and 76 | Maximum observed concentration. |
| Secondary | Pharmacokinetics Parameter: Tmax of INCB000928 | Baseline, Weeks 12, 24, 48 and 76 | Time to maximum concentration. |
| Secondary | Pharmacokinetics Parameter: Cmin of INCB000928 | Baseline, Weeks 12, 24, 48 and 76 | Minimum observed concentration. |
| Secondary | Pharmacokinetics Parameter: AUCt of INCB000928 | Baseline, Weeks 12, 24, 48 and 76 | Area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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