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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lupus Erythematosus, Systemic
• Intervention / Treatment: Drug: GDC-0853

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1194AAO
    • APRILLUS
  • La Plata, Argentina, 1900
    • Hospital Italiano de La Plata
  • San Juan, Argentina, 5400
    • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • San Miguel de Tucuman, Argentina, T4000AXL
    • Centro Medico Privado de Reumatologia
• Brazil
  • GO
    • Goiania, GO, Brazil, 74110-120
      • CIP - Centro Internacional de Pesquisa
  • MG
    • Juiz de Fora, MG, Brazil, 36036-330
      • Centro Mineiro de Pesquisa - CMIP
  • PR
    • Curitiba, PR, Brazil, 80440-080
      • Edumed - Educacao e Saude SA
  • RS
    • Porto Alegre, RS, Brazil, 90035-170
      • Centro de Pesquisas em Diabetes - CPD
  • SC
    • Itajai, SC, Brazil, 88301-220
      • Clínica de Neoplasias Litoral
  • SP
    • Santo Andre, SP, Brazil, 09060-650
      • Faculdade de Medicina do ABC - FMABC
    • Santo Andre, SP, Brazil, 09190-510
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
    • Sao Paulo, SP, Brazil, 01228-200
      • Centro de Pesquisas Clinicas; CPCLIN
    • Sao Paulo, SP, Brazil, 04023-000
      • Hospital Abreu Sodré - AACD
• Bulgaria
  • Plovdiv, Bulgaria, 4003
    • MHAT Plovdiv
  • Ruse, Bulgaria, 7000
    • Medical Center "Teodora", EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1000
    • Medical Center Excelsior OOD
  • Sofia, Bulgaria, 1784
    • MC "Synexus - Sofia", EOOD
  • Stara Zagora, Bulgaria, 6000
    • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
• Chile
  • Providencia, Chile, 7500571
    • CTR Estudios SPA
  • Santiago, Chile, 66901
    • Dermacross
  • Santiago, Chile, 7501126
    • Centro de Estudios Reumatologi
  • Santiago, Chile
    • Biomedica
• Colombia
  • Barranquilla, Colombia, 80020
    • Centro de Investigacion Medico Asistencial S.A.S
  • Barranquilla, Colombia, 00000
    • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
  • Bucaramanga, Colombia, 680003
    • Medicity S.A.S.
  • Bucaramanga, Colombia, 680003
    • Servimed S.A.S.
  • Medellin, Colombia, 050034
    • Hospital Pablo Tobon Uribe
• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
• Mexico
  • Mexico, Mexico, 07760
    • Hospital Angeles Lindavista
  • Saltillo, Mexico, 25000
    • Hospital Universitario de Saltillo
  • San Luis Potosi S.l.p., Mexico, 78240
    • Hospital Central Dr. Ignacio Morones Prieto
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • Centro de Investigacion Alberto Bazzoni S.A. de C.V.
  • Yucatan
    • Mérida, Yucatan, Mexico, 97000
      • Unidad de Atencion Medica e Investigacion en Salud S.C.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario Valladolid
  • Valladolid, Spain, 47012
    • Hospital Universitario Río Hortega
  • LA Coruña
    • A Coruna, LA Coruña, Spain, 15006
      • Fundacion Profesor Novoa Santos
• Taiwan
  • Kaohsiung City, Taiwan, 00833
    • Kaohsiung Chang Gung Memorial Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital; Louise Coote Lupus Unit
• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Valerius Medical Group
  • Florida
    • Boca Raton, Florida, United States, 33486
      • RASF-Clinical Research Center
    • Brandon, Florida, United States, 33511
      • Bay Area Arthritis And Osteoporosis
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Institute of Arthritis Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Ochsner Clinic Foundation
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • Shanahan Rheumatology & Immunology, PLLC
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research Inc
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research
    • Houston, Texas, United States, 77058-3675
      • Accurate Clinical Research
    • San Marcos, Texas, United States, 78666
      • Arthritis Clinic of Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Adverse Events (AEs)	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.	Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Lupus Erythematosus Responder-4 Index (SRI-4) 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.	Baseline up to Week 48
Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State	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).	Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)	Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)	Population PK model estimated plasma decay half life of GDC-0853 at steady-state.	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)	Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.	Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: GA30066; 2017-001764-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No