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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.

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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: GDC-0853 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: GDC-0853 (200mg) BID
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03407482    
Other Study ID Numbers: GA30066
2017-001764-37 ( EudraCT Number )
First Posted: January 23, 2018    Key Record Dates
Results First Posted: December 19, 2020
Last Update Posted: December 19, 2020
Last Verified: November 2020
Individual Participant Data (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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases