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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
- Systemic Sclerosis
Trial Status:
Recruiting
This trial runs in
Cities
- Barcelona
- Bydgoszcz
- Córdoba
- Dallas
- Haifa
- Kefar Sava
- La Tronche
- Leuven
- Lublin
- luik
- nadarzyn
- Paris
- Ramat Gan
- Rennes
- Rochester
- San Juan
- Sevilla
- Strasbourg
- Toulouse
- Washington
Trial Identifier:
NCT05462522 2021-004578-68 GA43360
Trial 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.
Genentech, Inc.
Sponsor
Phase 1
Phase
NCT05462522 , GA43360 , 2021-004578-68
Trial Identifier
RO7303509, Placebo
Treatments
Systemic Sclerosis
Condition
Official Title
A Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic Sclerosis
Eligibility Criteria
All
Gender
≥18 Years & ≤ 75 Years
Age
No
Healthy Volunteers
Inclusion Criteria
Inclusion Criteria for the MAD Stage:
- Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration
- Participants with diffuse cutaneous systemic sclerosis (dcSSc), ≥ 15 modified Rodnan Skin Score (mRSS) units or with limited cutaneous systemic sclerosis (lcSSc), ≥ 9 mRSS units
- Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential
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 72 hours
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
- Immunization with a live/attenuated vaccine within 4 weeks prior to initiation of study drug or planned during study
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
- History of solid organ or stem-cell transplantation
- 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
- Serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior to initiation of study drug or IV antibiotics within 28 days prior to initiation of study drug
- Any serious medical condition or abnormality in clinical laboratory tests
For the latest version of this information please go to www.forpatients.roche.com