A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
NCT ID: NCT05462522
Last Updated: 2025-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2023-01-16
2025-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MAD Stage
Participants will be randomized in a ratio of 4:1 to receive RO7303509 or placebo, as subcutaneous (SC) injection, one time per month for 3 months. You have a 20% chance of getting placebo.
RO7303509
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
Placebo
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
OSE Stage
Every participant in the OSE stage will receive study drug and no participant will receive placebo. Participants will receive RO7303509 as SC injection at the same dose as that administered during the MAD stage, one time per month for up to a year.
RO7303509
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
Interventions
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RO7303509
RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
Placebo
RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
Eligibility Criteria
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Inclusion Criteria
* 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
* No clinically significant change in eligibility status
* Completion of the MAD and ability to roll over into the OSE within 5 days
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Stanford University
Palo Alto, California, United States
Hospital For Special Surgery
New York, New York, United States
Metroplex Clinical Research Centre
Dallas, Texas, United States
Hospital de Alta Complejidad en Red ?El Cruce? Dr. Néstor Kirchner ? S.A.M.I.C.
Buenos Aires, , Argentina
Clinica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, , Argentina
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Grenoble - Albert Michallon
La Tronche, , France
Hopital Cochin
Paris, , France
CHU de Bordeaux
Pessac, , France
CHRU Rennes
Rennes, , France
Hopitaux Universitaires
Strasbourg, , France
Hopital Purpan
Toulouse, , France
Rambam Medical Center - PPDS
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, , Poland
Hospital Garcia de Orta
Almada, , Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
The Alliance Medical Sciences Campus
San Juan, , Puerto Rico
Institute of Rheumatology Belgrade - PPDS
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d Hebron
Barcelona, , Spain
Hospital Quironsalud Infanta Luisa
Seville, , Spain
Royal Free Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2021-004578-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GA43360
Identifier Type: -
Identifier Source: org_study_id
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