A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus ErythematosusMedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001039-11-PT
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
- Age 18-75 years, inclusive
- 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: SLE Disease Activity Index (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 (e.g. corticosteroids, anti-malarial, and/or immunosuppressant's) for SLE within specified dose ranges
- Participants must be willing to avoid pregnancy
- If on oral corticosteroids (OCS), the dose must be Stable doses of anti-malarial or immunosuppressive therapies
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
-Evidence of significant and active lupus-related renal disease or unstable renal disease prior to screening
- Neuropsychiatric or central nervous system lupus manifestations
- Estimated glomerular-filtration rate < 30 mL/min or on chronic renal replacement therapy
- History of receiving a solid organ transplant
- Newly diagnosed (within the last 24 weeks) transverse myelitis
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the clinical efficacy of GDC-0853 in combination with standard of care (SOC);<br> Secondary Objective: •To evaluate the clinical efficacy of GDC-0853 over time using the Systemic Lupus Erythematosus Responder Index (SRI-4) as a standardized disease activity measure<br> •To evaluate the clinical efficacy of GDC 0853 over time using BICLA and SRI-6 as standardized disease activity measures <br> •To evaluate if patients with high plasmablast signature levels have an enhanced clinical response to GDC-0853 relative to patients with low levels<br> •To evaluate the safety of GDC-0853 in combination with SOC therapy in patients with moderate to severe active SLE<br> •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach<br> ;Primary end point(s): 1. SRI-4 response at Week 48;Timepoint(s) of evaluation of this end point: 1. Week 48
- Secondary Outcome Measures
Name Time Method