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Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)

NCT02927080 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-09-26

Study results available
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Summary

Study A083-02 is a multi-center, Phase 2 study to evaluate the safety, tolerability, pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of locally-acting ACE-083 in patients with Facioscapulohumeral muscular dystrophy (FSHD) to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is randomized, double-blind, and placebo-controlled.

Conditions

Interventions

DRUG

ACE-083

Recombinant fusion protein.

DRUG

ACE-083 or placebo

Recombinant fusion protein or normal saline.

Sponsors & Collaborators

  • Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-09-17
Completion
2019-10-09

Countries

  • United States
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02927080 on ClinicalTrials.gov