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Saracatinib Trial TO Prevent FOP

NCT04307953 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-03

No results posted yet for this study

Summary

This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data.

Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20.

Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months.

Endpoints: Endpoints include objective change in heterotopic bone volume measured by low-dose whole-body computer tomography (CT) , \[18F\] NaF Positron Emission Tomography (PET) activity and patient reported outcome measures.

Conditions

Interventions

DRUG

AZD0530 Difumarate

AZD0530 for the duration of the trial

DRUG

Matching placebo

Matching placebo during 6 month RCT, AZD0530 thereafter

Sponsors & Collaborators

  • Royal National Orthopaedic Hospital NHS Trust

    collaborator OTHER

  • Klinikum Garmisch-Patenkirchen

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Innovative Medicines Initiative

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Elisabeth MW Eekhoff, MD, PhD · Amsterdam University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2025-05-06
Completion
2025-05-06

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307953 on ClinicalTrials.gov