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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 : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 17, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
Estimated Primary Completion Date : April 9, 2020
Estimated Study Completion Date : April 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: GDC-0853
Participants will receive GDC-0853 twice daily (BID) for 48 weeks, followed by a safety follow-up period of 8 weeks.
Drug: GDC-0853
Participants will receive 4 tablets of GDC-0853 orally BID.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48 [ Time Frame: Baseline up to Week 48 ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]


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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


Contacts
Contact: Reference Study ID Number: GA30066 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03407482     History of Changes
Other Study ID Numbers: GA30066
2017-001764-37 ( EudraCT Number )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases