An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT03407482|
Recruitment Status : Terminated (The study was ended early due to the lack of efficacy seen in the parent study GA30044.)
First Posted : January 23, 2018
Results First Posted : December 19, 2020
Last Update Posted : December 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic||Drug: GDC-0853||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus|
|Actual Study Start Date :||January 9, 2018|
|Actual Primary Completion Date :||November 20, 2019|
|Actual Study Completion Date :||November 20, 2019|
Experimental: GDC-0853 (200mg) BID
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks) ]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.
- Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48 [ Time Frame: Baseline 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.
- Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State [ Time Frame: Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]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).
- Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss) [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
- Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss) [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
- Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss) [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.
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): NCT03407482
|Study Director:||Clinical Trials||Hoffmann-La Roche|