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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
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE January 15, 2018
First Posted Date  ICMJE January 23, 2018
Results First Submitted Date  ICMJE October 20, 2020
Results First Posted Date  ICMJE December 19, 2020
Last Update Posted Date December 19, 2020
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE Drug: GDC-0853
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 8, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2018)
240
Actual Study Completion Date  ICMJE November 20, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Chile,   Colombia,   Korea, Republic of,   Mexico,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Germany,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT03407482
Other Study ID Numbers  ICMJE 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  ICMJE
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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP