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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03407482
• Date of registration: 15/01/2018
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
• Scientific 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
• Date of first enrolment: January 9, 2018
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03407482
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Korea, Republic of, Mexico, Portugal, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 76 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: GDC-0853

Primary Outcome(s)

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(s)

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)]

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)]

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)]

Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48 [Time Frame: Baseline up to Week 48]

Secondary ID(s)

GA30066

2017-001764-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors