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ACTIVE NOT RECRUITING
NCT04281485
PHASE3

Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.

Official title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF 06939926 FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

Key Details

Gender

MALE

Age Range

4 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2020-11-05

Completion Date

2039-04-15

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

GENETIC

PF-06939926

PF-06939926 will be administered as a single IV infusion at Year 1 for Cohort 1.

OTHER

Placebo

Placebo will be administered as a single IV infusion at Year 1 for Cohort 2.

OTHER

Placebo

Placebo will be administered as a single IV infusion at Year 2 for Cohort 1.

GENETIC

PF-06939926

PF-06939926 will be administered as a single IV infusion at Year 2 for Cohort 2

Locations (53)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Arkansas Children's

Little Rock, Arkansas, United States

UCLA Medical Center

Los Angeles, California, United States

University of Florida

Gainesville, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Fairway

Fairway, Kansas, United States

KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Rainbow

Kansas City, Kansas, United States

University of Kansas Hospital - Investigational Pharmacy

Kansas City, Kansas, United States

University of Kansas Hospital - Pediatric and Pediatric ICU - Operating Room

Kansas City, Kansas, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Pediatric Cardiology

Prairie Village, Kansas, United States

Lenox Baker Children's Hospital

Durham, North Carolina, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Primary Childrens Hospital

Salt Lake City, Utah, United States

University of Utah Clinical Neurosciences Center

Salt Lake City, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Seattle Children's

Seattle, Washington, United States

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

The Royal Children's Hospital Melbourne

Parkville, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

UZ Gent

Ghent, Belgium

UZ leuven

Leuven, Belgium

Alberta Children's Hospital

Calgary, Alberta, Canada

Children's Hospital - London Health Sciences Centre

London, Ontario, Canada

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital For Sick Children

Toronto, Ontario, Canada

CHU de Nantes- Hotel Dieu

Nantes, France

Hopital Necker

Paris, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitatsklinikum Essen

Essen, Germany

Hadassah University Medical Center, Ein Kerem

Jerusalem, Israel

Schneider Children's Medical Center of Israel

Petach Tikvah, Israel

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

IRCCS Ospedale Pediatrico Bambino Gesù

Rome, Italy

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Hyogo College of Medicine College Hospital

Nishinomiya, Hyōgo, Japan

National Center of Neurology and Psychiatry

Tokyo, Japan

Saint Petersburg State Paediatric Medical University

Saint Petersburg, Russia

State Autonomous Healthcare Institution of Sverdlovsk Region Children's City Clinical Hospital No 9

Yekaterinburg, Russia

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Inselspital, University Children's Hospital Berne

Bern, Switzerland

Universitaets-Kinderspital Zuerich

Zurich, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary

Newcastle upon Tyne, England, United Kingdom

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Great Ormond Street Institute of Child Health

London, United Kingdom