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Trial · NCT03188666

Results by group84

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsPlaceboParticipants with at least one TEAE24Participants
Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsREGN2477 10 mg/kg Q4WParticipants with at least one TEAE20Participants
Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsPlaceboParticipants with at least one serious TEAE2Participants
Period 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsREGN2477 10 mg/kg Q4WParticipants with at least one serious TEAE4Participants
Period 1: Number of Participants With TEAEs by SeverityPlaceboParticipants with at least one Mild TEAE9Participants
Period 1: Number of Participants With TEAEs by SeverityREGN2477 10 mg/kg Q4WParticipants with at least one Mild TEAE7Participants
Period 1: Number of Participants With TEAEs by SeverityPlaceboParticipants with at least one Moderate TEAE12Participants
Period 1: Number of Participants With TEAEs by SeverityREGN2477 10 mg/kg Q4WParticipants with at least one Moderate TEAE10Participants
Period 1: Number of Participants With TEAEs by SeverityPlaceboParticipants with at least one Severe TEAE3Participants
Period 1: Number of Participants With TEAEs by SeverityREGN2477 10 mg/kg Q4WParticipants with at least one Severe TEAE3Participants
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)
Placebo16.6Standard Error 9.11Percent Change
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)
REGN2477 10 mg/kg Q4W-8.1Standard Error 9.93Percent Change
Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by Computed Tomography (CT) at Week 28 (AHO)Placebo32.0Standard Error 18.66Percent Change
Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by Computed Tomography (CT) at Week 28 (AHO)REGN2477 10 mg/kg Q4W7.1Standard Error 20.43Percent Change
Period 2: Number of New HO Lesions as Assessed by CT at Week 56 Relative to Week 28 Scan (AHO COVID-19 mITT)Placebo/REGN2477 10 mg/kg Q4W0New HO Lesions
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)Placebo17.6Standard Error 9.73Percent Change
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)REGN2477 10 mg/kg Q4W-8.0Standard Error 10.14Percent Change
Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT at Week 28 (AHOC)Placebo34.9Standard Error 19.90Percent Change
Period 1: Percent Change From Baseline in the Total Volume of HO Lesions as Assessed by CT at Week 28 (AHOC)REGN2477 10 mg/kg Q4W7.0Standard Error 20.87Percent Change
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)
Placebo-0.17Standard Error 0.205Score on a Scale

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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