Phase 2
Completed N=260
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Source: ClinicalTrials.gov NCT02908100 ↗Enrolled (actual)
260
Serious AEs
9.7%
Results posted
Jul 2020
Primary outcomePrimary: Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48 — 44.2; 50.6; 51.7 Percentage of Participants — p=0.373
Summary
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48 |
44.2; 50.6; 51.7 | 0.373 |
| SECONDARY SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48 |
41.9; 50.6; 44.8 | 0.223 |
| SECONDARY SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24 |
43.0; 47.1; 47.1 | 0.614 |
| SECONDARY SRI-4 Response at Week 24 |
46.5; 52.9; 52.9 | 0.410 |
| SECONDARY SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels |
37.5; 52.4; 45.0; 54.5; 54.2; 63.2 | 0.378 |
| SECONDARY SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels |
33.3; 52.4; 40.0; 54.5; 54.2; 57.9 | 0.189 |
| SECONDARY SRI-6 Response at Week 24 and 48 |
31.4; 34.5; 33.3; 27.9; 39.1; 35.6 | 0.692 |
| SECONDARY BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48 |
47.5; 45.9; 44.6; 41.2; 52.9; 42.2 | 0.936 |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
76.2; 88.5; 78.4 | — |
| SECONDARY Plasma Concentrations of Fenebrutinib at Specified Timepoints |
NA; NA; 41.9; 180; 331; 612 | — |
Eligibility Criteria
Inclusion Criteria
- Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
- At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
- At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
- If on oral corticosteroids (OCS), the dose must be 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
- Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
- History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
- Neuropsychiatric or central nervous system lupus manifestations
- Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
- History of receiving a solid organ transplant
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
- History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
- Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
- Evidence of chronic and/or active hepatitis B or C
Data sourced from ClinicalTrials.gov (NCT02908100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.