A Phase 2 interventional study of GDC-0853 and Placebo in Systemic Lupus Erythematosus, sponsored by Genentech, Inc.. Completed at 70 sites in 12 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This is a 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).
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 260 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Placebo
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.
Drug: GDC-0853
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.
Drug: GDC-0853
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
Also known as: RO7010939
Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48
The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Time frame: Week 48
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
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].
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
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].
Time frame: Week 24
SRI-4 Response at Week 24
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Time frame: Week 24
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Time frame: Week 48
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
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Time frame: Week 48
SRI-6 Response at Week 24 and 48
The Systemic Lupus Erythematosus Responder Index (SRI)-6 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥6 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Time frame: Week 24, 48
BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48
The BICLA is a composite index that is defined as follows: \[1\] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; \[2\] No new BILAG A or more than one new BILAG B scores; \[3\] No worsening of total SLEDAI-2K score from baseline; \[4\] No significant deterioration (=\<10%) in physician's global assessment and \[5\] No treatment failure (initiation of non-protocol treatment).
Time frame: Week 24, 48
Percentage of Participants With Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline up to 8 weeks after the last dose of study drug (up to Week 56).
Plasma Concentrations of Fenebrutinib at Specified Timepoints
The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
Time frame: Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)
The study was conducted at 69 centers in 12 countries.
| Milestone | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Started | 86 | 87 | 87 |
| Completed | 63 | 66 | 66 |
| Not completed | 23 | 21 | 21 |
| Withdrew: Adverse event | 7 | 6 | 9 |
| Withdrew: Death | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 2 | 3 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 2 |
| Withdrew: Non-compliance with study drug | 1 | 1 | 2 |
| Withdrew: Non-compliance with contraceptive method | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Pregnancy | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 8 | 7 | 5 |
| Withdrew: Randomised in error | 1 | 0 | 0 |
The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48 | 44.2 | 50.6 | 51.7 |
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| 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 | 41.9 | 50.6 | 44.8 |
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 \[less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1\].
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| 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 | 43.0 | 47.1 | 47.1 |
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| SRI-4 Response at Week 24 | 46.5 | 52.9 | 52.9 |
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Plasmablast Signature Level Q1 | 37.5 | 52.4 | 45.0 |
| Plasmablast Signature Level Q2 | 54.5 | 54.2 | 63.2 |
| Plasmablast Signature Level Q3 | 36.8 | 52.4 | 52.0 |
| Plasmablast Signature Level Q4 | 50.0 | 42.9 | 47.8 |
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Plasmablast Signature Level Q1 | 33.3 | 52.4 | 40.0 |
| Plasmablast Signature Level Q2 | 54.5 | 54.2 | 57.9 |
| Plasmablast Signature Level Q3 | 36.8 | 52.4 | 44.0 |
| Plasmablast Signature Level Q4 | 45.0 | 42.9 | 39.1 |
The Systemic Lupus Erythematosus Responder Index (SRI)-6 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥6 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Week 24 | 31.4 | 34.5 | 33.3 |
| Week 48 | 27.9 | 39.1 | 35.6 |
The BICLA is a composite index that is defined as follows: \[1\] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; \[2\] No new BILAG A or more than one new BILAG B scores; \[3\] No worsening of total SLEDAI-2K score from baseline; \[4\] No significant deterioration (=\<10%) in physician's global assessment and \[5\] No treatment failure (initiation of non-protocol treatment).
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Week 24 | 47.5 | 45.9 | 44.6 |
| Week 48 | 41.2 | 52.9 | 42.2 |
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Percentage of Participants | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 76.2 | 88.5 | 78.4 |
The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
| ng/mL | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|
| Week 0 (Pre-dose) | NA ± NA | NA ± NA |
| Week 24 (Pre-dose) | 41.9 ± 62.4 | 180 ± 121 |
| Week 24 (2hr Post-dose) | 331 ± 226 | 612 ± 353 |
| Week 24 (4-6hr Post-dose) | 215 ± 131 | 414 ± 187 |
| Week 24 (8-10hr Post-dose) | 120 ± 111 | 233 ± 145 |
| Week 48 (Pre-dose) | 25.5 ± 28.1 | 137 ± 133 |
Collected over Baseline up to 8 weeks after the last dose of study drug (up to Week 56).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 2/84 (2.4%) | 9/84 (10.7%) | 42/84 (50%) |
| GDC-0853 (150mg) QD | 1/87 (1.1%) | 4/87 (4.6%) | 54/87 (62.1%) |
| GDC-0853 (200mg) BID | 0/88 (0%) | 12/88 (13.6%) | 51/88 (58%) |
| Event | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUSMusculoskeletal and connective tissue disorders | 2/84 | 1/87 | 2/88 |
| CONGESTIVE CARDIOMYOPATHYCardiac disorders | 1/84 | 0/87 | 0/88 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROMEGeneral disorders | 1/84 | 0/87 | 0/88 |
| EPSTEIN-BARR VIRUS INFECTIONInfections and infestations | 1/84 | 0/87 | 0/88 |
| GASTROENTERITIS BACTERIALInfections and infestations | 1/84 | 0/87 | 0/88 |
| INFECTED SKIN ULCERInfections and infestations | 1/84 | 0/87 | 0/88 |
| PNEUMONIAInfections and infestations | 1/84 | 0/87 | 0/88 |
| PYELONEPHRITISInfections and infestations | 1/84 | 0/87 | 1/88 |
| SEPTIC SHOCKInfections and infestations | 1/84 | 0/87 | 0/88 |
| URINARY TRACT INFECTIONInfections and infestations | 1/84 | 0/87 | 1/88 |
| Event | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID |
|---|---|---|---|
| URINARY TRACT INFECTIONInfections and infestations | 9/84 | 17/87 | 11/88 |
| LYMPHOPENIABlood and lymphatic system disorders | 6/84 | 2/87 | 10/88 |
| HEADACHENervous system disorders | 9/84 | 3/87 | 3/88 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 5/84 | 9/87 | 3/88 |
| NASOPHARYNGITISInfections and infestations | 5/84 | 8/87 | 6/88 |
| BACK PAINMusculoskeletal and connective tissue disorders | 2/84 | 8/87 | 4/88 |
| NAUSEAGastrointestinal disorders | 7/84 | 4/87 | 7/88 |
| BRONCHITISInfections and infestations | 6/84 | 6/87 | 7/88 |
| DIARRHOEAGastrointestinal disorders | 6/84 | 5/87 | 5/88 |
| NEUTROPENIABlood and lymphatic system disorders | 4/84 | 5/87 | 6/88 |
| Age, Continuous(Years) | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID | Total |
|---|---|---|---|---|
| Mean | 40.2 ± 11.5 | 43.3 ± 12.4 | 40.4 ± 10.6 | 41.3 ± 11.6 |
| Sex: Female, Male(Participants) | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID | Total |
|---|---|---|---|---|
| Female | 85 | 82 | 84 | 251 |
| Male | 1 | 5 | 3 | 9 |
| Race/Ethnicity, Customized(Participants) | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID | Total |
|---|---|---|---|---|
| Hispanic or Latino | 54 | 61 | 61 | 176 |
| Not Hispanic or Latino | 32 | 25 | 26 | 83 |
| Not Stated | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Placebo | GDC-0853 (150mg) QD | GDC-0853 (200mg) BID | Total |
|---|---|---|---|---|
| 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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Lupus Erythematosus, Systemic→
Genentech, Inc.