Registered outcomes18

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

1 to 18 of 18

Download this page as JSON

List	Outcome	Time frame	Description
Primary	Number of new HO lesions	At Week 56
Primary	Incidence and severity of treatment-emergent adverse events of special interest (AESIs)	Baseline to Week 56
Secondary	Number of clinician-assessed flare-ups	Through Weeks 28, 56 and 84	Investigator assess flare-up events according to his/her medical judgment. A FOP flare-up is characterized as episodic, painful inflammatory soft tissue swelling. Week 84 Only for Patients on Extended Treatment
Secondary	Occurrence of new HO lesions	At Weeks 28, 56 and 84	Reported as Yes/No Week 84 Only for Patients on Extended Treatment
Secondary	Total volume of new HO lesions	At Weeks 28, 56 and 84	Week 84 Only for Patients on Extended Treatment
Secondary	Occurrence of patient-reported flare-ups	Through Weeks 28 and 56	Reported as Yes/No
Secondary	Number of new HO lesions	At week 28 and 84	Week 84 Only for Patients on Extended Treatment
Secondary	Occurrence of clinician-assessed flare-ups	Through Weeks 28, 56 and 84	Reported as Yes/No Week 84 Only for Patients on Extended Treatment
Secondary	Number of patient-reported flare-ups	Through Weeks 28 and 56	Flare-up is defined as two or more of the following: pain, swelling, joint stiffness, or decrease in movement. The FOP flare-up dairy is a questionnaire and is self-completed by the participant daily.
Secondary	Change in joint function assessment by physician using cumulative analog joint involvement scale (CAJIS)	Baseline to Weeks 28 and 56	CAJIS is a clinician assessment of 15 major joints; each major joint rated normal unaffected (0), affected (1), or completely functionally ankylosed (2). The total score ranges from 0 to 30
Secondary	Change in pulmonary function as assessed by spirometry	Baseline at Weeks 28 and 56	Forced vital capacity (FVC) and Forced expiratory volume in 1 second (FEV1) and the ratio of FEV1/FVC will be determined by spirometry.
Secondary	Change in disease severity as assessed by the Patient Global Impression of Severity (PGIS)	Baseline to Weeks 28 and 56	PGIS is a single item, self-administered questionnaire to assess the patient's global impression of severity
Secondary	Change in disease severity as assessed by the Patient's Global Impression of Change (PGIC)	At Weeks 28 and 56	PGIC is a single item, self-administered questionnaire to assess the patient's global impression of change
Secondary	Change in disease severity as assessed by the Clinician's Global Impression of Change (CGIC)	At Weeks 28 and 56	CGIC is a single-item questionnaire to assess the clinician's global impression of change
Secondary	Concentration of total activin A in serum over time	Through Week 56
Secondary	Concentration of garetosmab in serum over time	Through Week 56
Secondary	Incidence of anti-drug antibodies (ADA) to garetosmab over time	Through Week 56
Secondary	Titer of ADA to garetosmab over time	Through Week 56

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.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT05394116/registered

API reference For AI assistants