A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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| ClinicalTrials.gov Identifier: NCT02908100 |
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Recruitment Status :
Completed
First Posted : September 20, 2016
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Systemic Lupus Erythematosus |
| Interventions |
Drug: GDC-0853 Drug: Placebo |
| Enrollment | 260 |
Participant Flow
| Recruitment Details | The study was conducted at 69 centers in 12 countries. |
| Pre-assignment Details | An overall total of 616 participants were screened into the study, of which 356 participants were screen failures. 260 participants (Intent-To-Treat/ITT population) were randomized into the study, of which 1 participant did not receive any study treatment meaning that the Safety population consisted of 259 participants. |
| Arm/Group Title | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
 Arm/Group Description |
Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. | Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. | Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. |
| Period Title: Overall Study | |||
| Started | 86 | 87 | 87 |
| Completed | 63 | 66 | 66 |
| Not Completed | 23 | 21 | 21 |
| Reason Not Completed | |||
| Adverse Event | 7 | 6 | 9 |
| Death | 2 | 0 | 0 |
| Lack of Efficacy | 2 | 3 | 3 |
| Lost to Follow-up | 0 | 1 | 2 |
| Non-Compliance With Study Drug | 1 | 1 | 2 |
| Non-Compliance With Contraceptive Method | 1 | 0 | 0 |
| Physician Decision | 0 | 1 | 0 |
| Pregnancy | 1 | 2 | 0 |
| Withdrawal by Subject | 8 | 7 | 5 |
| Randomised in Error | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. | Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. | Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 86 | 87 | 87 | 260 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 86 participants | 87 participants | 87 participants | 260 participants | |
| 40.2 (11.5) | 43.3 (12.4) | 40.4 (10.6) | 41.3 (11.6) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 86 participants | 87 participants | 87 participants | 260 participants | |
| Female |
85 98.8%
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82 94.3%
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84 96.6%
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251 96.5%
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| Male |
1 1.2%
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5 5.7%
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3 3.4%
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9 3.5%
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 87 participants | 87 participants | 260 participants |
| Hispanic or Latino | 54 | 61 | 61 | 176 | |
| Not Hispanic or Latino | 32 | 25 | 26 | 83 | |
| Not Stated | 0 | 1 | 0 | 1 | |
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[1]
Measure Description: Ethnicity
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 86 participants | 87 participants | 87 participants | 260 participants |
| American Indian or Alaska native | 11 | 8 | 17 | 36 | |
| Asian | 7 | 1 | 2 | 10 | |
| Black or African American | 11 | 15 | 13 | 39 | |
| Multiple | 1 | 1 | 3 | 5 | |
| White | 56 | 62 | 52 | 170 | |
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[1]
Measure Description: Race
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title: | Medical Communications |
| Organization: | Hoffmann-La Roche |
| Phone: | 800 821-8590 |
| EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT02908100 |
| Other Study ID Numbers: |
GA30044 2016-001039-11 ( EudraCT Number ) |
| First Submitted: | September 14, 2016 |
| First Posted: | September 20, 2016 |
| Results First Submitted: | May 22, 2020 |
| Results First Posted: | July 7, 2020 |
| Last Update Posted: | July 7, 2020 |