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

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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).

Key facts

Study ID

NCT02908100

Run by

Genentech, Inc.

People needed

260

Starts

2017-01-19

Expected to finish

2019-07-16

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 </= 40 mg/day prednisone (or equivalent)
• Stable doses of anti-malarial or immunosuppressive therapies
• Participants must be willing to avoid pregnancy

You may not qualify if…

• 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

Where it is running

• Valerius Medical Group & Research Ctr of Greater Long Beach — Los Alamitos, California, United States
• RASF-Clinical Research Center — Boca Raton, Florida, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Institute of Arthritis Research — Idaho Falls, Idaho, United States
• Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. — Wichita, Kansas, United States
• Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
• The Arthritis & Diabetes Clinic, Inc.; Research — Monroe, Louisiana, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Saint Lawrence Health System — Canton, New York, United States
• New York University School of Medicine — New York, New York, United States
• Shanahan Rheumatology & Immunology, PLLC — Raleigh, North Carolina, United States
• Ohio State University Clinical Trials Management Office — Columbus, Ohio, United States
• Tekton Research Inc — Austin, Texas, United States
• Accurate Clinical Research — Houston, Texas, United States
• Accurate Clinical Research — Houston, Texas, United States
• Arthritis Clinic Of Central Texas — San Marcos, Texas, United States
• Organizacion Medica de Investigacion — Buenos Aires, Argentina
• APRILLUS — Buenos Aires, Argentina
• Hospital Italiano de La Plata — La Plata, Argentina
• CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan, Argentina
• Centro Medico Privado de Reumatologia; Reumathology — San Miguel, Argentina
• CEDOES - Diagnóstico e Pesquisa — Vitória, Espírito Santo, Brazil
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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