A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
Completed · Phase 1 · Has a placebo group
Conditions studied: Systemic Sclerosis
In brief
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. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
Key facts
- Study ID
- NCT05462522
- Run by
- Genentech, Inc.
- People needed
- 56
- Starts
- 2023-01-16
- Expected to finish
- 2025-07-11
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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