A Study of the Safety and Efficacy of GDC 0853 in Patients 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001039-11-GB

Enrollment

240

Registered

2016-08-24

Start date

2016-11-16

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: GDC-0853 Product Code: RO7010939/F13 Pharmaceutical Form: Tablet INN or Proposed INN: not available yet CAS Number: 143404

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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-malarials, and/or immunosuppressants) for SLE within specified dose ranges - Participants must be willing to avoid pregnancy - If on oral corticosteroids (OCS), the dose must be =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Neuropsychiatric or central nervous system lupus manifestations - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the clinical efficacy of GDC-0853 in combination with standard of care (SOC); 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 •To evaluate the clinical efficacy of GDC 0853 over time using BICLA and SRI-6 as standardized disease activity measures •To evaluate if patients with high plasmablast signature levels have an enhanced clinical response to GDC-0853 relative to patients with low levels •To evaluate the safety of GDC-0853 in combination with SOC therapy in patients with moderate to severe active SLE •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach ;Primary end point(s): 1. SRI-4 response at Week 48;Timepoint(s) of evaluation of this end point: 1. Week 48	—

Measure

Time frame

Main Objective: To evaluate the clinical efficacy of GDC-0853 in combination with standard of care (SOC); 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 •To evaluate the clinical efficacy of GDC 0853 over time using BICLA and SRI-6 as standardized disease activity measures •To evaluate if patients with high plasmablast signature levels have an enhanced clinical response to GDC-0853 relative to patients with low levels •To evaluate the safety of GDC-0853 in combination with SOC therapy in patients with moderate to severe active SLE •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach ;Primary end point(s): 1. SRI-4 response at Week 48;Timepoint(s) of evaluation of this end point: 1. Week 48

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Secondary

Measure	Time frame
Secondary end point(s): 1. SRI-4 response at Week 48 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 36 through Week 48 2. 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 3. SRI-4 response at Week 24 4. SRI-4 response at Week 48 in patients with high vs. low plasmablast signature levels 5. 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 6. SRI-6 response at Weeks 24 and 48 7. BICLA response at Weeks 24 and 48 8. Incidence of adverse events using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale to grade adverse events 9. Changes in vital signs, physical findings, electrocardiogram (ECGs), and clinical laboratory results following GDC-0853 administration 10. Plasma concentrations of GDC-0853 at specified timepoints ; Timepoint(s) of evaluation of this end point: 1. Week 48 2-3. Week 24 4-5. Week 48 6-7. Week 24 and Week 48 8-9. Up to 60 weeks 10. Pre dose at Week 1, Week 4, Week 24, and Week 48; at unscheduled or flare or early termination visit	—

Measure

Time frame

Secondary end point(s): 1. SRI-4 response at Week 48 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 36 through Week 48 2. 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 3. SRI-4 response at Week 24 4. SRI-4 response at Week 48 in patients with high vs. low plasmablast signature levels 5. 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 6. SRI-6 response at Weeks 24 and 48 7. BICLA response at Weeks 24 and 48 8. Incidence of adverse events using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale to grade adverse events 9. Changes in vital signs, physical findings, electrocardiogram (ECGs), and clinical laboratory results following GDC-0853 administration 10. Plasma concentrations of GDC-0853 at specified timepoints ; Timepoint(s) of evaluation of this end point: 1. Week 48 2-3. Week 24 4-5. Week 48 6-7. Week 24 and Week 48 8-9. Up to 60 weeks 10. Pre dose at Week 1, Week 4, Week 24, and Week 48; at unscheduled or flare or early termination visit

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Countries

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

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026