A study of the long-term effects of fenebrutinib treatment in patients with lupus

An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

  • Autoimmune Disorder
Trial Status:

Terminated

This trial runs in
Countries
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Mexico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom
  • United States
Trial Identifier:

NCT03407482 2017-001764-37 GA30066

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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

      This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03407482 , GA30066 , 2017-001764-37 Trial Identifier
      All Gender
      ≥ 18 Years & ≤ 76 Years Age
      No Healthy Volunteers

      This clinical trial was done to study a new medicine called, “fenebrutinib”, for the treatment of patients with “lupus”. Researchers wanted to know if fenebrutinib was safe over a long-term period when given to patients with lupus. One hundred and sixty patients took part in this study at 49 study centers in 11 countries.

      Trial Summary

      This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03407482 , GA30066 , 2017-001764-37 Trial Identifier
      GDC-0853 Treatments
      Lupus Erythematosus, Systemic Condition
      Official Title

      A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 76 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Able to comply with the study protocol, in the investigator's judgment
      • Completion of Study GA30044 up to 48 weeks
      • Acceptable safety and tolerability during Study GA30044 as determined by the investigator
      Exclusion Criteria
      • Met protocol-defined treatment-stopping criteria during Study GA30044
      • An adverse event in Study GA30044 that required permanent discontinuation of study drug
      • In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
      • Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor

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