FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

June 14, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

March 31, 2028

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

ION363

ION363 will be administered by IT bolus injection.

DRUG

Placebo

Placebo will be administered by IT bolus injection.

Trial Locations (25)

3000

UZ Leuven, Leuven

3080

Seoul National University Hospital, Seoul

4763

Hanyang University Seoul Hospital, Seoul

8907

Hospital Universitari de Bellvitge, Barcelona

9007

Kantonsspital St. Gallen, Sankt Gallen

10032

Columbia University Medical Center, New York

10126

Citta della Salute e della Scienza di Torino - Ospedale le Molinette, Torino

11217

Taipei Veterans General Hospital (VGHTP), Taipei

18147

Universitaetsmedizin Rostock, Rostock

21205

Johns Hopkins University, Baltimore

43210

The Ohio State University Wexner Medical Center, Columbus

63110

Washington University School of Medicine, St Louis

84132

University of Utah, Salt Lake City

89081

Universitätsklinikum Ulm, Ulm

92037

University of California San Diego, La Jolla

94304

Stanford University Medical Center, Palo Alto

02114

Massachusetts General Hospital, Boston

04038-002

PSEG Centro de Pesquisa Clinica S.A., São Paulo

H3A 2B4

Montreal Neurological Institute, Montreal

D08 A978

St. James Hospital, Dublin

143-8541

Toho University Omori Medical Center, Tokyo

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

30-721

Linden spólka z ograniczona odpowiedzialnoscia spólka komandytow, Krakow

SE-901 85

University Hospital of Umea, Umeå

SE5 9RT

King's College Hospital, London

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY