Trial · NCT04307953

Saracatinib Trial TO Prevent FOP

NCT04307953, Phase 2, Active not recruiting, Amsterdam UMC, location VUmc

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Saracatinib Trial TO Prevent FOP. Trials, record NCT04307953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04307953

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Saracatinib Trial TO Prevent FOP
NCT number: NCT04307953
Status: Active not recruiting
Phases: Phase 2
Enrollment: 20 participants, estimated
Lead sponsor: Amsterdam UMC, location VUmc
Conditions: Fibrodysplasia Ossificans Progressiva
Interventions: AZD0530 Difumarate, Matching placebo
First posted: 2020-03-13
Last updated: 2026-09-02
Other registries' IDs: eudract:2019-003324-20

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Number of new active HO lesions on [18F] NaF PET/ CT	Baseline, month 6	The change between the two arms in development of new active heterotopic bone lesions measured by \[18F\] NaF PET/low-dose whole body CT during the initial 6-month RCT
Secondary	Safety and tolerability assessments are the incidence and severity of adverse events (AE) during the RCT at the end of week 26.	Baseline, month 6 (+overall duration study)
Secondary	New active HO lesions of the placebo arm during 26 weeks RCT compared to its roll over to 26-week open label treatment	Baseline, month 6, month 12	Number of individual new active HO lesions assessed by \[18F\]-NaF PET between the placebo arm at week 26 and the subsequent open-label phase at week 52 among patients receiving placebo during the RCT
Secondary	The change in heterotopic bone volume measured by low-dose whole body CT over twelve-months treatment during open-label extension of AZD0530 compared to the historical data of Clementia (NCT02322255)	Baseline, month 6, month 12, month 18
Secondary	Change in the volume of individual HO lesions	Baseline, month 6, month 12, month 18	measured by low-dose whole body CT over the initial 6 month RCT and the change over twelve-months therapy during open-label extension of AZD0530 compared to the historical data of Clementia and compared to the 6 months placebo-arm.
Secondary	Change in number of HO lesions measured by CT over the initial 6 month RCT and in addition the change over twelve-months during open-label extension of AZD0530 compared to the historical data of Clementia and compared to the 6 months placebo-arm.	Baseline, month 6, month 12, month 18
Secondary	In patients follow-up of lesion activity	Baseline, month 6, month 12	by 18F-NaF PET over the initial 6 month RCT and over months 6-12 compared to the 6 months RCT of the placebo arm, including change from baseline in 18F-NaF Standard Uptake Volume (SUVmean or peak) of individual active HO sites up to most active seven lesions.
Secondary	Follow-up of HO growth	Baseline, month 6, month 12	Follow-up up to 7 most active HO lesion identified at CT at baseline: Change in volume from baseline to 6 for comparion in RCT en at 12 months for compariosn placebo RCT with its switch over
Secondary	Change and percent change from baseline in biomarkers of bone formation levels in serum over time.	Baseline, week 3 through month 18	Including Total Procollagen Type 1 N-Terminal Propeptide (P1NP), Alkaline Phosphatase (AP) fasting cross-linked C-terminal telopeptide of type I colla-gen (βCTX). Selected genetic markers for FOP activity
Secondary	Joint function assessment by physician at baseline and week 3, month 3,6,9,12,and18 by the cumulative analog joint involvement scale (CAJIS) and the quantitative detailed multi-joint assessment and mounth at baseline and month 6, 12 and 18	baseline, week 3, month 3,6,9,12,and 18

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

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

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35650602	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04307953

GET https://conductscience.org/api/trials/v1/NCT04307953/registered

API reference For AI assistants