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History of Changes for Study: NCT02908100
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Latest version (submitted June 22, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 16, 2016 None (earliest Version on record)
2 September 20, 2016 Outcome Measures and Study Status
3 September 21, 2016 Arms and Interventions and Study Status
4 September 27, 2016 Arms and Interventions, Eligibility, Outcome Measures and Study Status
5 October 3, 2016 Study Status and Contacts/Locations
6 November 1, 2016 Contacts/Locations, Study Status and Oversight
7 May 5, 2017 Recruitment Status, Contacts/Locations and Study Status
8 May 9, 2017 Oversight and Study Status
9 May 10, 2017 Contacts/Locations and Study Status
10 July 14, 2017 Contacts/Locations and Study Status
11 August 11, 2017 Contacts/Locations, Study Status, Outcome Measures, Eligibility, Study Design and Study Identification
12 February 27, 2018 Contacts/Locations and Study Status
13 March 12, 2018 Study Status and Contacts/Locations
14 March 27, 2018 Outcome Measures, Contacts/Locations, Eligibility and Study Status
15 May 2, 2018 Contacts/Locations and Study Status
16 July 4, 2018 Recruitment Status, Study Status and Contacts/Locations
17 July 19, 2018 Contacts/Locations and Study Status
18 October 26, 2018 Study Status
19 October 29, 2018 Study Status
20 November 8, 2018 Study Status
21 December 17, 2018 Contacts/Locations and Study Status
22 February 27, 2019 Contacts/Locations and Study Status
23 October 2, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
24 January 15, 2020 Study Status and Contacts/Locations
25 February 18, 2020 Study Status and Contacts/Locations
26 May 22, 2020
Quality Control Review has not concluded Returned: June 5, 2020
Contacts/Locations, Arms and Interventions, Outcome Measures, Study Status, Document Section, Study Design, Study Description and Study Identification
27 June 22, 2020 Study Status, Adverse Events, Outcome Measures and Contacts/Locations
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Study NCT02908100
Submitted Date:  September 16, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: GA30044
Brief Title: A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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
Secondary IDs: 2016-001039-11 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Not yet recruiting
Study Start: December 2016
Primary Completion: June 2019 [Anticipated]
Study Completion: June 2019 [Anticipated]
First Submitted: September 14, 2016
First Submitted that
Met QC Criteria:
September 16, 2016
First Posted: September 20, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 16, 2016
Last Update Posted: September 20, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genentech, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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).
Detailed Description:
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 241 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GDC-0853 Low Dose
Participants will receive GDC-0853 low dose twice daily (BID), orally, every 12 hours starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Drug: GDC-0853
Participants will receive GDC-0853 low dose orally starting on Day 1 and ending at Week 48.
Other Names:
  • RO7010939
Experimental: GDC-0853 High Dose
Participants will receive GDC-0853 high dose daily (QD), orally, starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.
Drug: GDC-0853
Participants will receive GDC-0853 high dose orally every 12 hours starting on Day 1 and ending at Week 48.
Other Names:
  • RO7010939
Placebo Comparator: Placebo
Participants will receive matching placebo to GDC-0853 orally 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 orally starting on Day 1 and ending at Week 48
Open or close this module Outcome Measures
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 early termination (approximately Week 60) ]

5. Changes in Vital Signs Following GDC-0853 Administration
[ Time Frame: Baseline up to early termination (approximately Week 60) ]

6. Chnages in Physical Findings Following GDC-0853 Administration
[ Time Frame: Baseline up to early termination (approximately Week 60) ]

7. Changes in Electrocardiogram (ECGs) Findings Following GDC-0853 Administration
[ Time Frame: Baseline up to early termination (approximately Week 60) ]

8. Changes in Clinical Laboratory Results Following GDC-0853 Administration
[ Time Frame: Baseline up to early termination (approximately Week 60) ]

9. 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 ]

10. 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 ]

11. 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 ]

12. 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 ]

13. 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 ]

14. 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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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 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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: GA30044 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. and Canada)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Alabama
Anniston, Alabama, United States, 36207
United States, Arizona
Tuscon, Arizona, United States, 85724
United States, California
Huntington Beach, California, United States, 92646
Modesto, California, United States, 95357
Torrance, California, United States, 90505
United States, Connecticut
Trumbull, Connecticut, United States, 06611
United States, Florida
Boca Raton, Florida, United States, 33486
Orlando, Florida, United States, 32804
Tampa, Florida, United States, 33603
United States, Kansas
Wichita, Kansas, United States, 67208
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Boston, Massachusetts, United States, 2118
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Texas
Austin, Texas, United States, 78717
Houston, Texas, United States, 77034
Argentina
Buenos Aires, Argentina, B7600FZN
Buenos Aires, Argentina, C1015ABO
Buenos Aires, Argentina, C1194AAO
Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Cordoba, Argentina, X5000JHQ
Córdoba, Argentina, 5016
La Plata, Argentina, 1725
Mendoza, Argentina, 5500
San Fernando, Argentina, 1646
San Juan, Argentina, 5400
San Miguel, Argentina, T4000AXL
Tucuman, Argentina, 4000
Brazil, GO
Goiânia, GO, Brazil, 74110-120
Brazil, MG
Belo Horizonte, MG, Brazil, 31270-901
Juiz de Fora, MG, Brazil, 36010-570
Brazil, MT
Cuiabá, MT, Brazil, 78040-360
Brazil, PR
Curitiba, PR, Brazil, 80440-080
Curtiba, PR, Brazil, 80030-110
Brazil, RJ
Rio de Janeiro, RJ, Brazil, 21941-913
Brazil, RS
Passo Fundo, RS, Brazil, 99010-080
Porto Alegre, RS, Brazil, 90035-170
Brazil, SP
Santo Andre, SP, Brazil, 09060-650
Santo Andre, SP, Brazil, 09190-610
São Paulo, SP, Brazil, 01244-030
Bulgaria
Ruse, Bulgaria, 7000
Sofia, Bulgaria, 1000
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1784
Chile
Pto Varas, Chile
Santiago, Chile, 66901
Santiago, Chile, 7500000
Santiago, Chile, 7501126
Santiago, Chile
Colombia
Armenia, Colombia, 00000
Barranquilla, Colombia, 00000
Barranquilla, Colombia
Bucaramanga, Colombia, 680003
Bucaramanga, Colombia
Cali, Colombia, 00000
Medellin-Antioquia, Colombia
France
Angers, France, 49933
Paris, France, 75475
Pessac, France, 33600
Tours, France, 37044
Korea, Republic of
Daejeon, Korea, Republic of, 35233
Gyeonggi-do, Korea, Republic of, 443-380
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 05030
Seoul, Korea, Republic of, 150-713
Mexico
Cuernavaca, Mexico, 62290
Leon, Mexico, 37000
Merida, Mexico, 97134
Mexico, Mexico, 07760
Monterrey, Mexico, 64000
Saltillo, Mexico, 25000
San Luis Potosi, Mexico, 78240
Mexico, Coahuila
Torreon, Coahuila, Mexico, 27000
Mexico, Jalisco
Guadalajara, Jalisco, Mexico, 44690
Mexico, Mexico City (federal District)
Mexico, Mexico City (federal District), Mexico, 14000
Spain
Barcelona, Spain, 08035
Spain, Alava
Vitoria-Gasteiz, Alava, Spain, 01009
Spain, La Coruña
A Coruña, La Coruña, Spain, 15006
Thailand
Bangkok, Thailand, 10330
United Kingdom
Brighton, United Kingdom, BN2 5BE
Open or close this module IPDSharing
Plan to Share IPD:
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Links:
Available IPD/Information:

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