Setrusumab vs Placebo for Osteogenesis Imperfecta

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

February 21, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2027

Conditions
Osteogenesis Imperfecta
Interventions
BIOLOGICAL

Setrusumab

A fully human sclerostin neutralizing monoclonal antibody (mAb) administered once a month (QM) via intravenous (IV) infusion

OTHER

Placebo

A 5% dextrose/glucose solution administered QM via IV infusion

Trial Locations (44)

19104

The Children's Hospital of Philadelphia, Philadelphia

19803

Nemours/ Alfred i. duPoint Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21205

Kennedy Krieger Institute, Baltimore

28203

Atrium Health Levine Children's Hospital, Charlotte

33612

University of South Florida, Tampa

37232

Vanderbilt University Medical Center, Nashville

39106

Otto von Guericke University Magdeburg, Magdeburg

43205

Nationwide Children's Hospital- Ohio State University College of Medicine, Columbus

46202

Indiana University Hospital, Indianapolis

53792

UW Health University Hospital, Madison

60707

Shriners Hospitals for Children - Chicago, Chicago

63110

Washington University School of Medicine, St Louis

68114

Children's Hospital and Medical Center, Omaha

72202

Arkansas Children's Hospital, Little Rock

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

80045

Children's Hospital Colorado, Aurora

87106

New Mexico Clinical Research & Osteoporosis Center, Inc., Albuquerque

90027

Children's Hospital Los Angeles, Los Angeles

95817

Shriners Hospital for Children - Northern California, Sacramento

97074

Musculoskeletal Center Würzburg, Würzburg

06106

Connecticut Children's Medical Center, Hartford

06510

Yale New Haven Hospital, New Haven

02115

Boston Children's Hospital, Boston

QLD 4101

Queensland Paediatric Endocrinology, South Brisbane

Unknown

Royal Children's Hospital, Melbourne

London Health Sciences Center, London

University of Toronto- The Hospital for Sick Children (SickKids), Toronto

Institut Imagine, Paris

University of Cologne, Cologne

Istituto Ortopedico Rizzoli, Bologna

Universita Degli Studi Di Verona, Verona

Wilhelmina Children's Hospital, Utrecht

Uniwersytet Medyczny w Lodzi - Klinika Endokrynologii i Chorob Metabolicznych, Lodz

Gazi University, Ankara

Marmara University, Istanbul

Royal Manchester Childrens Hospital, Manchester

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

H4A 3J1

McGill University Health Centre, Montreal

00161

Azienda Ospedaliera Universitaria Policlinico Umberto I, Rome

1649-028

Hospital de Santa Maria, Lisbon

4099-001

Centro Hospitalar do Porto, Porto

S10 2TH

Sheffield Children's NHS Foundation Trust, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mereo BioPharma

INDUSTRY

lead

Ultragenyx Pharmaceutical Inc

INDUSTRY