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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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 - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: RO7303509
    RO7303509 will be administered as SC injection monthly, as specified in each treatment group.
  • Drug: Placebo
    RO7303509 matching placebo will be administered as SC injection monthly, during the MAD stage.
Experimental
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.
  • Drug: RO7303509
    RO7303509 will be administered as SC injection monthly, as specified in each treatment group.

More Details

Status
Active, not recruiting
Sponsor
Genentech, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.