An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

• ClinicalTrials.gov Identifier: NCT03407482
• Recruitment Status: Terminated
• First Posted: January 23, 2018
• Results First Posted: December 19, 2020
• Last Update Posted: December 19, 2020
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: January 15, 2018
• First Posted Date: January 23, 2018
• Results First Submitted Date: October 20, 2020
• Results First Posted Date: December 19, 2020
• Last Update Posted Date: December 19, 2020
• Actual Study Start Date: January 9, 2018
• Actual Primary Completion Date: November 20, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2020)

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.

• Original Primary Outcome Measures (submitted: January 15, 2018): Percentage of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug until 8 weeks after last dose of study drug (up to 56 weeks) ]

Current Secondary Outcome Measures (submitted: October 20, 2020)

• 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.

Original Secondary Outcome Measures (submitted: January 15, 2018)

• Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48 [ Time Frame: Baseline up to Week 48 ]
• Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t) of GDC-0853 [ Time Frame: Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]
• Steady-State Concentration (Ctrough) of GDC-0853 [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]
• Plasma Half-Life (t1/2) of GDC-0853 [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]
• Apparent Clearance (CL/F) of GDC-0853 [ Time Frame: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lupus Erythematosus, Systemic

Intervention

Drug: GDC-0853

Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.

Study Arms

Experimental: GDC-0853 (200mg) BID

Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).

Intervention: Drug: GDC-0853

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 8, 2019): 160
• Original Estimated Enrollment (submitted: January 15, 2018): 240
• Actual Study Completion Date: November 20, 2019
• Actual Primary Completion Date: November 20, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Able to comply with the study protocol, in the investigator's judgment
• Completion of Study GA30044 up to 48 weeks
• Acceptable safety and tolerability during Study GA30044 as determined by the investigator

Exclusion Criteria:

• Met protocol-defined treatment-stopping criteria during Study GA30044
• An adverse event in Study GA30044 that required permanent discontinuation of study drug
• In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
• Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 76 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Bulgaria, Chile, Colombia, Korea, Republic of, Mexico, Spain, Taiwan, United Kingdom, United States
• Removed Location Countries: Germany, Portugal

Administrative Information

• NCT Number: NCT03407482
• Other Study ID Numbers: GA30066; 2017-001764-37 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: November 2020