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Trial · NCT04577820

Registered outcomes41

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
SecondaryPercent change in mean maximum standard uptake volume (SUVmax) of individual active HO site(s) by PETBaseline and week 56
SecondaryChange in total lesion activity by PETBaseline and week 28
SecondaryChange in total lesion activity by PETBaseline and week 56
SecondaryPercent change in total lesion activity by PETBaseline and week 28
SecondaryPercent change in total lesion activity by PETBaseline and week 56
SecondaryChange in the total volume of HO lesions as assessed by CTBaseline and week 28
SecondaryChange in the total volume of HO lesions as assessed by CTBaseline and week 56
SecondaryPercent change in the total volume of HO lesions as assessed by CTBaseline and week 28
SecondaryPercent change in the total volume of HO lesions as assessed by CTBaseline and week 56
SecondaryChange in number of HO lesions as assessed by PETBaseline and week 28HO lesions defined as target and new lesions relative to baseline.
SecondaryChange in number of HO lesions as assessed by PETBaseline and week 56Defined above
SecondaryChange in the number of HO lesions detectable by CTBaseline and week 28Defined above
SecondaryChange in the number of HO lesions detectable by CTBaseline and week 56Defined above
SecondaryTime-weighted average (standardized area under curve [AUC]) change in daily pain due to FOP, as measured using the daily numeric rating scale (NRS)Baseline through week 28
The NRS is a categorical rating scale used by patients to rate their pain associated with FOP. Patients will be asked to rate their pain on a scale that ranges from "0" (no pain) to "10" (worst possible pain).
SecondaryTime-weighted average (standardized AUC) change in daily pain due to FOP, as measured using the daily NRSBaseline through week 56
SecondaryTotal dosage of glucocorticoids useThrough week 56
SecondaryIncidence and severity of TEAEsThrough week 56
SecondaryConcentration of total activin A in serum over timeThrough week 56
SecondaryPharmacokinetic (Pk) Profile - concentrations of garetosmab in serum over timeThrough week 56
SecondaryImmunogenicity as measured by Anti-drug antibodies (ADA) to garetosmab over timeThrough week 28

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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