Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD

PHASE3TerminatedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

March 3, 2021

Primary Completion Date

June 12, 2023

Study Completion Date

December 14, 2023

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

Pamrevlumab

Pamrevlumab will be administered per dose and schedule specified in the arm description.

DRUG

Placebo

Placebo will be administered per schedule specified in the arm description.

DRUG

Corticosteroids

Systemic deflazacort or equivalent potency of corticosteroids administered orally

Trial Locations (52)

168

Fondazione Policlinico Universitario Agostino Gemelli, Roma

1100

Klinik Favoriten, Vienna

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3052

Murdoch Children's Research Institute, Parkville

4000

Centre Hospitalier Régional de la Citadelle, Liège

9000

Universitair Ziekenhuis Gent, Ghent

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

19104

Children's Hospital of Philadelphia, Philadelphia

20132

IRRCS Ospedale San Raffaele, Milan

20162

Centro Clinico NeMO, Milan

21205

Kennedy Krieger Institute, Baltimore

22903

University of Virginia Children's Hospital, Charlottesville

23507

Children's Hospital of The King's Daughters, Norfolk

23842

Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia, Bosisio Parini

30329

Rare Disease Research Center, Atlanta

32610

University of Florida Health Shands Hospital, Gainesville

33614

Rare Disease Research - Tampa, Tampa

37232

Vanderbilt University Medical Center, Nashville

44093

Centre Hospitalier Universitaire Nantes - Hôtel Dieu, Nantes

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49503

Spectrum Health Hospitals Helen DeVos Children's Hospital, Grand Rapids

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Children's Wisconsin Corporate Center, Milwaukee

60611

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

63110

Washington University School of Medicine in St. Louis, St Louis

66205

University of Kansas Medical Center Research Institute, Fairway

67200

Hôpital Hautepierre, Strasbourg

72202

Arkansas Children's Hospital, Little Rock

75012

Association Institut de Myologie, Paris

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

84108

University of Utah Health, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

92161

University of California San Diego Health, San Diego

95817

University of California Davis Children's Hospital, Sacramento

97239

Shriners Hospital for Children, Portland

98105

Seattle Children's Hospital, Seattle

100730

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing

401122

Children's Hospital of Chongqing Medical University, Chongqing

410008

Xiangya Hospital Central South University, Changsha

510080

The 1st Affiliated Hospital, Sun Yat-sen University, Guangzhou

610041

West China Second University Hospital, Sichuan University, Chengdu

01655

University of Massachusetts Memorial Center, Worcester

48109-4234

C.S. Mott Children's Hospital, Ann Arbor

45229-3026

Cincinnati Children's Hospital Medical Center, Cincinnati

N6A 5W9

London Health Sciences Centre, London

Unknown

Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo, Roma

Leiden Universitair Medisch Centrum, Leiden

Radboud Universitair Medisch Centrum, Nijmegen

08035

Hospital Universitari Vall d'Hebrón, Barcelona

LS1 3EX

Leeds Teaching Hospitals NHS Trust, Leeds

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

FibroGen

INDUSTRY