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

• Status: Recruiting
• Trial end date: 2024-06-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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