Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

April 17, 2023

Primary Completion Date

November 1, 2026

Study Completion Date

May 2, 2029

Conditions
Spinal Muscular AtrophySpinal Muscular Atrophy Type 3Spinal Muscular Atrophy Type 2SMANeuromuscular DiseasesMuscular AtrophyAtrophyMuscular Atrophy, SpinalNeuromuscular ManifestationsAnti-myostatin
Interventions
DRUG

Apitegromab

Apitegromab (SRK-015) is an investigational, fully human immunoglobulin G4 monoclonal antibody that specifically binds to human proforms (i.e., inactive precursor forms) of myostatin, pro- and latent- myostatin, with high affinity, inhibiting activation of myostatin, a negative regulator of muscle growth and strength.

Trial Locations (49)

106

Fondazione Policlinico Universitario A. Gemelli, Roma

3000

UZ Leuven, Leuven

3508

UMC Utrecht, Utrecht

4000

CHR Citadelle, Liège

9000

UZ Gent, Ghent

10032

Columbia University Medical Center, New York

16147

Istituto Giannina Gaslini, Centro Traslazionale di Miologia e Patologie Neurodegenerative, Genova

19104

The Children's Hospital of Philadelphia, Philadelphia

20133

Carlo Besta Neurological Research Institute, Milan

20162

NeuroMuscular Omnicentre, Milan

21287

Johns HopkinsHospital, Baltimore

23606

Children's Specialty Group PLLC (Children's Hospital of The King's Daughters), Newport News

27157

Wake Forest University School of Medicine, Winston-Salem

31059

CHU Toulouse Hopital des Enfants, Toulouse

32827

Nemours Biomedical Research, Orlando

38105

St. Jude Children's Research Hospital, Memphis

43215

Nationwide Children's Hospital, Columbus

45147

Universitatsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

49503

Helen DeVos Children's Hospital, Grand Rapids

52242

University of Iowa, Iowa City

53127

Universitätskinderklinik Bonn, Abteilung für Neuropädiatrie und SPZ, Bonn

53792

University of Wisconsin Hospital, Madison

55101

Gillette Children's Specialty Healthcare, Saint Paul

59037

CHRU de Lille - Hpital Jeanne de Flandre, Lille

60611

Lurie Children's Hospital of Chicago, Chicago

63110

Washington University Medical Campus, St Louis

66205

University of Kansas Medical Center, Fairway

75012

Hopital Trousseau - I-Motion, Paris

75207

University of Texas Southwestern - Pediatric Neurology, Dallas

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

80045

Children's Hospital Colorado, Aurora

80337

Klinikum der Universitat Munchen, Dr. von Haunersches Kinderspital, Abteilung fur Kinderneurologie und Entwicklungsneurologie, Munchen, Bayern

84112

University of Utah, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

92037

UCSD Altman Clinical and Translational Research, La Jolla

94304

Stanford Neuroscience Health Center, Palo Alto

97239

Oregon Health & Science University, Portland

98115

Seattle Children's Hospital, Seattle

98125

UOC NEUROLOGIA E MALATTIE NEUROMUSCOLARI A.O.U Policlinico G. Martino, Messina

02115

Boston Children's Hospital, Boston

80-211

Uniwersyteckie Centrum Kliniczne, Gdansk

60-355

Uniwersytecki Szpital Kliniczny w Poznaniu, Oddział Kliniczny Neurologii Dzieci i Młodzieży, Poznan

04-730

Instytut Pomnik - Centrum Zdrowia Dziecka, Warsaw

08950

Hospital Sant Joan de Deau, Barcelona

LS1 3EX

Leeds Children's Hospital Clinical Research, Leeds

WC1N 1EH

Great Ormond Street Hospital for Children, London

OX3 0ER

University of Oxford, Oxford

All Listed Sponsors
lead

Scholar Rock, Inc.

INDUSTRY