A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular Dystrophy

PHASE2TerminatedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

November 24, 2014

Primary Completion Date

April 30, 2018

Study Completion Date

November 23, 2018

Conditions
Duchenne Muscular Dystrophy
Interventions
BIOLOGICAL

PF-06252616

PF-06252616 IV Infusion, 3 dose levels (5mg/kg, 20 mg/kg and 40 mg/kg) will be investigated within each subject

DRUG

Placebo

Trial Locations (66)

1431

Clinical Densitometry and Bone Metabolic Disease Department, General and Clinical Pathology Clinic, Sofia

Hospital Pharmacy, UMHAT Alexandrovska, Sofia

Imaging Diagnostic Clinic,UMHAT Alexandrovska, Sofia

Neurology Disease Clinic,UMHAT Alexandrovska, Sofia

UMHAT Alexandrovska Cardiology Department,Internal Diseases Propaedeutic Clinic, Sofia

4101

Lady Cilento Children's Hospital, South Brisbane

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

16147

UOC Farmacia-Istituto Gianna Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico, Genova

UOC Medicina Fisica Riabilitativa, Genova

UOC Neurologia Pediatrica e Malattie Muscolari, Genova

UOC Radiologia-Istituto Gianna. Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere, Genova

UOS Dipartimentale Endocrinologia Clinica Sperimentale, Genova

19104

The Children's Hospital of Philadelphia, Philadelphia

21205

Kennedy Krieger Institute Out-patient center, Baltimore

Kennedy Krieger Institute, Baltimore

21287

Johns Hopkins Hospital, Baltimore

Johns Hopkins Investigational Drug Service, Baltimore

27705

Duke University Medical Center,Lenox Baker Children's Hospital, Durham

27710

Duke University, Investigational Drug Pharmacy, Durham

33612

Shriners Hospitals for Children - Tampa, Tampa

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

52242

University of Iowa ICTS, Iowa City

55455

University of Minnesota Masonic Children's Hospital, Minneapolis

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

St Louis Children's Hospital, St Louis

66160

University of Kansas Medical Center, Landon Center on Aging, Kansas City

University of Kansas Medical Center, Kansas City

66205

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

University of Kansas-Clinical Research Center, Investigational Pharmacy, Fairway

80045

Children's Hospital Colorado, Aurora

84108

Center for Clinical and Translational Sciences, Salt Lake City

Utah Center for Advanced Imaging and Research (UCAIR), Salt Lake City

84112

Investigational Drug Services, Salt Lake City

University of Utah, Department of Neurology, Salt Lake City

84132

University of Utah Medical Center, Salt Lake City

University of Utah School of Medicine, Salt Lake City

90095

Ronald Reagan UCLA Medical Center, Los Angeles

Ronald Reagan UCLA Pharmacy, Los Angeles

UCLA (David Geffen School of Medicine), Los Angeles

95817

University of California, Davis Medical Center, Sacramento

02114

Massachusetts General Hospital, Boston

T3B 6A8

Alberta Children's Hospital, Calgary

V6H3V4

UBC Children's and Women's Health Center of British Columbia, Vancouver

N6A 5W9

Children's Hospital- London Health Sciences Centre, London

H3T 1C5

CHU Sainte-Justine, Montreal

00150

Dipartimento Pediatrico Universitario-Ospedaliero Endocrinologia, Rome

00165

Farmacia Ospedaliera, IRCCS Ospedale Pediatrico Bambino Gesù, Padiglione Sant'Onofrio, Rome

Malattie Neuromuscolari e Neurodegenerative, IRCCS Ospedale Pediatrico Bambino Gesù, Rome

Ospedale Pediatrico Bambino Gesù - Centro Trial, DPUO - Padiglione Salviati, Rome

00168

U.O.C Farmacia, Rome

U.O.C. Neuropsichiatria Infantile, Fondazione Policlinico, Rome

663-8501

Hyogo college of medicine hospital, Hyōgo

187-8551

National Center of Neurology and Psychiatry, Tokyo

02-097

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Apteka Szpitalna Blok F, Warsaw

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, I Katedra i Klinika Kardiologii, Warsaw

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, II Zaklad Radiologii Klinicznej, Warsaw

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, Klinika Neurologii, Warsaw

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie, Laboratorium Centralne, Warsaw

02-106

MTZ Clinical Research Sp.z o.o., Warsaw

L12 2AP

Alder Hey Children's NHS Foundation Trust, Liverpool

L14 5AB

Alder Hey Children's NHS Foundation Trust, Liverpool

WC1N 3JH

Dubowitz Neuromuscular Centre Institute of Child Health, London

Great Ormond Street Hospital, London

NE1 3BZ

Institute of Genetic Medicine, Muscle Team, Newcastle upon Tyne

NE1 4LP

Clinical Research Facility, Newcastle upon Tyne

Royal Victoria Infirmary Research Pharmacy, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02310763 - A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Duchenne Muscular Dystrophy | Biotech Hunter | Biotech Hunter