A Phase 2 interventional study of GDC-0853 in Lupus Erythematosus, Systemic, sponsored by Genentech, Inc.. Terminated at 53 sites in 11 countries. Open to participants aged 18 Years to 76 Years. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.
Exclusion Criteria:
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Drug: GDC-0853
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) 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 abnormal laboratory values or abnormal clinical test results), 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 until 8 weeks after the last dose of study drug (up to 56 weeks)
Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to 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: Baseline up to Week 48
Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State
Population PK model estimated AUC of GDC-0853 From Time 0 to Time t (AUC0-t) at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)\*hour (hr).
Time frame: Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)
Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
Time frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)
Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
Time frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)
Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.
Time frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
The study was conducted at 50 centers in 11 countries.
| Milestone | GDC-0853 (200mg) BID |
|---|---|
| Started | 160 |
| Completed | 29 |
| Not completed | 131 |
| Withdrew: Adverse event | 12 |
| Withdrew: Disease relapse | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Non-compliance with study drug | 1 |
| Withdrew: Pregnancy | 2 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Study terminated by sponsor | 106 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Data entry error | 1 |
An Adverse Event (AE) 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 abnormal laboratory values or abnormal clinical test results), 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 | GDC-0853 (200mg) BID |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | 64.4 |
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.
No measurements were reported for this outcome.
Population PK model estimated AUC of GDC-0853 From Time 0 to Time t (AUC0-t) at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)\*hour (hr).
No measurements were reported for this outcome.
Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
No measurements were reported for this outcome.
Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
No measurements were reported for this outcome.
Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.
No measurements were reported for this outcome.
Collected over Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GDC-0853 (200mg) BID | 0/160 (0%) | 4/160 (2.5%) | 31/160 (19.4%) |
| Event | GDC-0853 (200mg) BID |
|---|---|
| CELLULITISInfections and infestations | 1/160 |
| INFECTIVE TENOSYNOVITISInfections and infestations | 1/160 |
| URINARY TRACT INFECTIONInfections and infestations | 1/160 |
| LUMBAR VERTEBRAL FRACTUREInjury, poisoning and procedural complications | 1/160 |
| SYSTEMIC LUPUS ERYTHEMATOSUSMusculoskeletal and connective tissue disorders | 1/160 |
| Event | GDC-0853 (200mg) BID |
|---|---|
| URINARY TRACT INFECTIONInfections and infestations | 15/160 |
| NASOPHARYNGITISInfections and infestations | 13/160 |
| NAUSEAGastrointestinal disorders | 9/160 |
| Age, Continuous(Years) | GDC-0853 (200mg) BID |
|---|---|
| Mean | 42.8 ± 11.5 |
| Sex: Female, Male(Participants) | GDC-0853 (200mg) BID |
|---|---|
| Female | 155 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | GDC-0853 (200mg) BID |
|---|---|
| Hispanic or Latino | 117 |
| Not Hispanic or Latino | 42 |
| Not Stated | 1 |
| Race/Ethnicity, Customized(Participants) | GDC-0853 (200mg) BID |
|---|---|
| American Indian or Alaska native | 24 |
| Asian | 5 |
| Black or African American | 22 |
| Multiple | 5 |
| White | 104 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Lupus Erythematosus, Systemic→
Genentech, Inc.