A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

January 16, 2023

Primary Completion Date

July 11, 2025

Study Completion Date

July 11, 2025

Conditions
Systemic Sclerosis
Interventions
DRUG

RO7303509

RO7303509 will be administered as SC injection monthly, as specified in each treatment group.

DRUG

Placebo

RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.

Trial Locations (25)

3000

UZ Leuven, Leuven

11000

Institute of Rheumatology Belgrade - PPDS, Belgrade

11040

Military Medical Academy, Belgrade

31000

Hopital Purpan, Toulouse

33600

CHU de Bordeaux, Pessac

35000

CHRU Rennes, Rennes

38700

Centre Hospitalier Universitaire de Grenoble - Albert Michallon, La Tronche

41010

Hospital Quironsalud Infanta Luisa, Seville

67200

Hopitaux Universitaires, Strasbourg

75014

Hopital Cochin, Paris

94304

Stanford University, Palo Alto

3109601

Rambam Medical Center - PPDS, Haifa

4428164

Meir Medical Center, Kfar Saba

10021-4823

Hospital For Special Surgery, New York

75235-6262

Metroplex Clinical Research Centre, Dallas

B1888AAE

Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C., Buenos Aires

T4000IHE

Clinica Mayo de U.M.C.B. S.R.L, San Miguel de Tucumán

85-168

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz

20-607

Zespol Poradni Specjalistycznych REUMED, Lublin

2801-915

Hospital Garcia de Orta, Almada

3000-075

Centro Hospitalar E Universitário de Coimbra EPE, Coimbra

00935-0001

The Alliance Medical Sciences Campus, San Juan

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitario Vall d Hebron, Barcelona

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY

NCT05462522 - A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis | Biotech Hunter | Biotech Hunter