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

COMPLETEDPHASE2

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

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

NCT02908100•Genentech, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 \</= 40 mg/day prednisone (or 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
+1 more criteria

Locations (70)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Key Dates

Start Date

January 19, 2017

Primary Completion Date

May 28, 2019

Completion Date

July 16, 2019

Last Updated

May 8, 2024

Enrollment

260

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

GDC-0853

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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