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
Countries
  • United States
Trial Identifier:

NCT05462522 2021-004578-68 GA43360

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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

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