A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02908100
• Date of registration: 14/09/2016
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
• Scientific title: A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
• Date of first enrolment: January 19, 2017
• Target sample size: 260
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02908100
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Colombia, France, Germany, Korea, Republic of, Mexico, Portugal, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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 equivalent)

- Stable doses of anti-malarial or immunosuppressive therapies

- Participants must be willing to avoid pregnancy

Exclusion Criteria:

- Proteinuria > 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: GDC-0853

Drug: Placebo

Primary Outcome(s)

Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48 [Time Frame: Week 48]

Secondary Outcome(s)

SRI-6 Response at Week 24 and 48 [Time Frame: Week 24, 48]

BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48 [Time Frame: Week 24, 48]

SRI-4 Response at Week 24 [Time Frame: Week 24]

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 [Time Frame: Week 48]

Percentage of Participants With Adverse Events (AEs) [Time Frame: Baseline up to 8 weeks after the last dose of study drug (up to Week 56).]

Plasma Concentrations of Fenebrutinib at Specified Timepoints [Time Frame: Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)]

SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and [Time Frame: Week 24]

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 ( [Time Frame: Week 48]

SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels [Time Frame: Week 48]

Secondary ID(s)

2016-001039-11

GA30044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/07/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02908100