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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02908100
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: GDC-0853 (high dose) Drug: GDC-0853 (low dose) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arm Intervention/treatment
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.



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

Secondary Outcome Measures :
  1. SRI-4 Response at Week 24 [ Time Frame: Week 24 ]
  2. 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 ]
  3. 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 ]
  4. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to end of study (approximately Week 60) ]
  5. Area Under the Concentration Time-Curve From Time 0 to Time t (AUC0-t) [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  6. Maximum Concentration Observed (Cmax) [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  7. Time to Maximum Concentration (tmax) [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  8. Steady-State Concentration at the end of a Dosing Interval (Ctrough) [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  9. Half-Life (t1/2) [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  10. Apparent Clearance (CL/F)\n [ Time Frame: Pre-dose at Week 0, pre-dose at Week 4, pre and post-dose at Week 24, and pre-dose at Week 48; at unscheduled or flare or early termination visit ]
  11. Percentage of Participants with a Reduction of Greater than or Equal to 4 Points from Baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Week 24, Week 48 ]
  12. Percentage of Participants with No New Organ System Affected by 1 or More British Isles Lupus Assessment Group 2004 (BILAG-2004) Grade A or 2 or More BILAG-2004 Grade B Items [ Time Frame: Week 24, Week 48 ]
  13. Percentage of Participants with No Worsening of Physician's Global Assessment Visual Analog Scale (VAS) by Greater Than or Equal to 0.30 Points [ Time Frame: Week 24, Week 48 ]


Information from the National Library of Medicine

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

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 ≥ 6 (at screening only) with clinical SLEDAI-2K score >/= 4.0, 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:

  • Evidence of lupus nephritis
  • Neuropsychiatric or central nervous system lupus manifestations
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908100


Contacts
Contact: Reference Study ID Number: GA30044 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02908100     History of Changes
Other Study ID Numbers: GA30044
2016-001039-11 ( EudraCT Number )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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