Trial · NCT03188666
Outcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Up to Week 28 | The safety analysis set included all randomized participants who received any study drug and was analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Period 1: Number of Participants With TEAEs by Severity | Up to Week 28 | The safety analysis set included all randomized participants who received any study drug and was analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Period 1: Time-Weighted Average (Standardized Area Under the Curve [AUC]) of the Percent Change From Baseline in Total Lesion Activity by Fluorine-18-labeled Sodium Fluoride (18^F-NaF) Positron Emission Tomography (PET) at Week 28 (AHO) | Baseline and Week 28 | Baseline-active heterotopic ossification analysis set (AHO) included all randomized participants who had at least one active HO lesion at baseline; and was based on the treatment allocated (as randomized). | Percent Change | LEAST_SQUARES_MEAN |
| PRIMARY | Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by Computed Tomography (CT) at Week 28 (AHO) | Week 28 | AHO analysis set included all randomized participants who had at least one active HO lesion at baseline was based on the treatment allocated (as randomized). | Percent Change | LEAST_SQUARES_MEAN |
| PRIMARY | Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | New HO Lesions | NUMBER |
| PRIMARY | Period 1: Time-weighted Average (Standardized AUC) of the Percent Change From Baseline in Total Lesion Activity Assessed by 18^F-NaF PET at Week 28 (AHOC) | Week 28 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Percent Change | LEAST_SQUARES_MEAN |
| PRIMARY | Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT at Week 28 (AHOC) | Week 28 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Percent Change | LEAST_SQUARES_MEAN |
| SECONDARY | Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to Fibrodysplasia Ossificans Progressiva (FOP) Assessed by Daily Numeric Rating Scale (NRS) at Week 28 (AHO) | Week 28 | AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Period 1: Time-weighted Average (Standardized AUC) of the Change From Baseline in Daily Pain Due to FOP, Assessed by Daily NRS at Week 28 (AHOC) | Week 28 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) Assessed by 18^F-NaF PET at Week 8 (AHOC) | Week 8 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | Percent Change | MEAN |
| SECONDARY | Period 1: Percent Change From Baseline in 18^F-NaF SUVmax of Individual Active HO Site(s) as Assessed by 18^F-NaFPET at Week 8 (AHO) | Week 8 | AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized). | Percent Change | MEAN |
| SECONDARY | Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHOC) | Week 28 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | HO Lesions | MEAN |
| SECONDARY | Period 1: Change From Baseline in Number of HO Lesions as Assessed by 18^F-NaF PET at Week 28 (AHO) | Week 28 | AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized). | HO Lesions | MEAN |
| SECONDARY | Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHOC) | Week 28 | AHOC analysis set included all randomized participants with the classic ACVR1 \[R206H\] mutation and who had at least one AHO at baseline, as defined by 18\^F-NaF PET positivity; and was based on the treatment allocated (as randomized). Overall number of participants analyzed are the participants who were evaluable for this outcome measure. | HO Lesions | MEAN |
| SECONDARY | Period 1: Change From Baseline in Number of HO Lesions Detectable by CT at Week 28 (AHO) | Week 28 | AHO analysis set included all randomized participants who had at least one active HO lesion at baseline; based on the treatment allocated (as randomized). | HO Lesions | MEAN |
| SECONDARY | Period 2: Number of New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | New HO lesions | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | Percentage of Participants | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With New HO Lesions as Assessed by 18^F-NaF PET at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in Period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | Percentage of Participants | NUMBER |
| SECONDARY | Period 2: Number of New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | New HO lesions | NUMBER |
| SECONDARY | Period 2: Percentage of Participants With New HO Lesions as Assessed by CT Only at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT) | Week 28, Week 56 | COVID-19 mITT: All AHO participants who received a treatment in period 2 for whom at least 1 post-Week 28 scan was collected and the period between any consecutive doses was less than 9 weeks (63 days) before the 1st post-week 28 scan. Overall number of participants analyzed are the participants who were evaluable for this outcome measure. Separate analyses were conducted from week 56 relative to baseline for participants on treatment during both periods (REGN2477/REGN2477) as planned. | Percentage of Participants | NUMBER |
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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