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

November 24, 2020 updated by: Genentech, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Rio 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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).
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)
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).
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)
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.
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)
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.
Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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