Try our beta test site
Trial record 9 of 19 for:    lupus | Open Studies | United States, Kansas | United States, Michigan | United States, Minnesota

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02908100
First received: September 14, 2016
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging 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).

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: GDC-0853 (high dose)
Drug: GDC-0853 (low dose)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

Secondary Outcome Measures:
  • SRI-4 Response at Week 24 [ 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 (</=) Day 1 Dose During Week 36 Through Week 48 [ Time Frame: Week 48 ]
  • 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 [ Time Frame: Week 24 ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to early termination (approximately Week 60) ]
  • Changes in Vital Signs Following GDC-0853 Administration [ Time Frame: Baseline up to early termination (approximately Week 60) ]
  • Chnages in Physical Findings Following GDC-0853 Administration [ Time Frame: Baseline up to early termination (approximately Week 60) ]
  • Changes in Electrocardiogram (ECGs) Findings Following GDC-0853 Administration [ Time Frame: Baseline up to early termination (approximately Week 60) ]
  • Changes in Clinical Laboratory Results Following GDC-0853 Administration [ Time Frame: Baseline up to early termination (approximately Week 60) ]
  • Area Under the Concentration Time-Curve From Time 0 to Time t (AUC0-t) [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]
  • Maximum Concentration Observed (Cmax) [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]
  • Time to Maximum Concentration (tmax) [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]
  • Steady-State Concentration at the end of a Dosing Interval (Ctrough) [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]
  • Half-Life (t1/2) [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]
  • Apparent Clearance (CL/F)\n [ Time Frame: Pre-dose at Week 1, Week 4, pre and post-dose Week 24, and Week 48; at unscheduled or flare or early termination visit ]

Estimated Enrollment: 241
Study Start Date: December 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDC-0853 Low Dose
Participants will receive either GDC-0853 or matching placebo orally twice daily, every 12 hours starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Drug: GDC-0853 (low dose)
Participants will receive GDC-0853 once daily, and matching placebo twice daily, orally, starting on Day 1 and ending at Week 48.
Other Name: RO7010939
Experimental: GDC-0853 High Dose
Participants will receive GDC-0853 orally, twice daily, every 12 hours starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Drug: GDC-0853 (high dose)
Participants will receive GDC-0853 twice daily, orally every 12 hours starting on Day 1 and ending at Week 48.
Other Name: RO7010939
Placebo Comparator: Placebo
Participants will receive matching placebo to GDC-0853, orally, every 12 hours starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Drug: Placebo
Participants will receive matching placebo to GDC-0853 tablets twice daily, orally, every 12 hours starting on Day 1 and ending at Week 48.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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: Safety of Estrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score >/=6 (with clinical SELENA-SLEDAI score >/= 4.0); Physician's global assessment >/= 1.0 (out of 3); and currently receiving at least one standard oral treatment for SLE
  • Participants must be willing to avoid pregnancy
  • If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
  • Stable doses of anti-malarial or immunosuppressive therapies

Exclusion Criteria:

  • Neuropsychiatric or central nervous system lupus manifestations
  • Estimated glomerular-filtration rate < 30 millileter 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02908100

Contacts
Contact: Reference Study ID Number: GA30044 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 93 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02908100     History of Changes
Other Study ID Numbers: GA30044  2016-001039-11 
Study First Received: September 14, 2016
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 23, 2017