Multiple Sclerosis Clinical Trial

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

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. The MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 9 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria for the MAD Stage:

Weight of 45-150 kg at screening
Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration from first non-Raynaud's symptom
Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential for 4 months after last dose of study drug

Inclusion Criteria for the OSE Stage:

No clinically significant change in eligibility status
Completion of the MAD and ability to roll over into the OSE within 5 days

Exclusion Criteria:

Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy
Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted
History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
Major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose
Positive hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody test at screening
Any serious medical condition or abnormality in clinical laboratory tests

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05462522

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

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There are 30 Locations for this study

See Locations Near You

Stanford University
Palo Alto California, 94304, United States
Medstar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Mayo Clinic - Cancer Center - Rochester - PPDS
Rochester Minnesota, 55905, United States
Metroplex Clinical Research Centre
Dallas Texas, 75235, United States
Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
Buenos Aires , B1888, Argentina
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán , T4000, Argentina
UZ Leuven
Leuven , 3000, Belgium
CHU de Liège
Liège , 4000, Belgium
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche , 38700, France
Hopital Cochin
Paris , 75014, France
CHRU Rennes
Rennes , 35000, France
Hopitaux Universitaires
Strasbourg , 67200, France
Hopital Purpan
Toulouse , 31000, France
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Rambam Medical Center - PPDS
Haifa , 31096, Israel
Lady Davis Carmel Medical Center
Haifa , 34362, Israel
Meir Medical Center; Rheumatology Dept
Kfar Saba , 44281, Israel
Sheba Medical Center - PPDS
Ramat-Gan , 52620, Israel
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Klinika Reumatologii
Bydgoszcz , 85-16, Poland
Szpital Specjalistyczny im. Jozefa Dietla w Krakowie
Kraków , 31-12, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin , 20-60, Poland
Lecznica MAK-MED NZOZ
Nadarzyn , 05-83, Poland
Hospital Garcia de Orta
Almada , 2801-, Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra , 3000-, Portugal
The Alliance Medical Sciences Campus; University Hospital
San Juan , 00935, Puerto Rico
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitario Vall d Hebron
Barcelona , 08035, Spain
C.H. Regional Reina Sofia - PPDS
Cordoba , 14004, Spain
Hospital Quironsalud Infanta Luisa
Sevilla , 41010, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT05462522

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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