Systemic Lupus Erythematosus MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descripti
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18-76 years - Completion of Study GA30044 up to 48 weeks - Acceptable safety and tolerability during Study GA30044 as determined by the investigator - Women of childbearing potential must have a negative urine pregnancy test at baseline - For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Met protocol-defined treatment-stopping criteria during Study GA30044 - An adverse event in Study GA30044 that required permanent discontinuation of study drug - During Study GA30044, treatment with any therapy that is prohibited in this study - In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the patient at undue risk from a safety perspective - Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of study drug - Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator in consultation with the Medical Monitor - Any major episode of infection requiring hospitalization or treatment with IV antibiotics within the last 4 weeks of study GA30044 - Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) - Patients who experienced a de novo or reactivated serious viral infection, such as hepatitis B virus or hepatitis C virus (HCV) during Study GA30044 - Patients who developed a malignancy (with the exception of non-serious local and resectable basal or squamous cell carcinoma of the skin) during the Phase II Study GA30044 - 12-lead ECG at the Week 48 visit of Study GA30044 that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results - Current treatment with medications that are well known to prolong the QT interval at doses that have a clinically meaningful effect on QT, as determined by the investigator - Estimated glomerular-filtration rate (based on the 4-variable Modification of Diet in Renal Disease equation) 1.5 × ULN (unless due to known autoimmune hepatitis, Total bilirubin > 1.2 ULN, Amylase or lipase > 2 × ULN, Hemoglobin < 7 g/dL, ANC < 1.5 × 109/L, Absolute lymphocyte count (ALC) < 0.5 × 109/L, Platelet count < 50,000/µL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 48 weeks;Secondary Objective: •To evaluate the clinical efficacy of GDC-0853 in combination with standard of care over time •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach ;Primary end point(s): 1.The nature, frequency, severity, and timing of adverse events 2.Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC 0853 administration ;Timepoint(s) of evaluation of this end point: 1-2. Up to 56 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.SLE Responder Index -4 response up to Week 48 2.Steady-state PK parameters such as area under the concentration–time curve from time 0 to time t (AUC0-t), Ctrough, half-life (t1/2), and apparent clearance (CL/F) ;Timepoint(s) of evaluation of this end point: 1.Up to Week 48 2.Baseline (Day 1), Week 24, Week 48, at unscheduled visit, flare visit and early terminate | — |
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Korea, Republic of, Mexico, Portugal, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed