Lupus Erythematosus, SystemicPhase 2NCT03407482
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 2 study testing GDC-0853 in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 53 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- GDC-0853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 53 sitesin 11 countries
- Study dates
- 9 Jan 2018to 20 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 11 countries.
53 sites in 11 countries
United States11 sites
Tekton Research Inc
Austin, Texas, 78745
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809
RASF-Clinical Research Center
Boca Raton, Florida, 33486
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
Clinical Research of West Florida
Clearwater, Florida, 33765
Accurate Clinical Research
Houston, Texas, 77058-3675
Accurate Clinical Research
Houston, Texas, 77089
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Valerius Medical Group
Los Alamitos, California, 90720
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, 27617
Arthritis Clinic Of Central Texas
San Marcos, Texas, 78666
Brazil9 sites
Edumed - Educação e Saúde SA
Curitiba, Paraná, 80440-080
CIP - Centro Internacional de Pesquisa
Goiânia, Goiás, 74110-120
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, 36036-330
Centro de Pesquisas em Diabetes - CPD
Porto Alegre, Rio Grande do Sul, 90035-170
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
Santo André, São Paulo, 09190-510
Centro de Pesquisas Clinicas; CPCLIN
São Paulo, São Paulo, 01228-200
Hospital Abreu Sodré - AACD
São Paulo, São Paulo, 04023-000
Bulgaria6 sites
MHAT Plovdiv
Plovdiv, 4003
Medical Center "Teodora", EOOD
Rousse, 7000
Medical Center Excelsior OOD
Sofia, 1000
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
MC "Synexus - Sofia", EOOD
Sofia, 1784
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000
Colombia5 sites
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, 00000
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, 80020
Medicity S.A.S.
Bucaramanga, 680003
Servimed S.A.S.
Bucaramanga, 680003
Hospital Pablo Tobon Uribe
Medellín, 050034
Mexico5 sites
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, 97000
Hospital Angeles Lindavista
México, 07760
Hospital Universitario de Saltillo
Saltillo, 25000
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi S.l.p., 78240
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, 27000
Spain5 sites
Fundación Profesor Novoa Santos
A Coruña, LA Coruña, 15006
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Clinico Universitario Valladolid
Valladolid, 47005
Hospital Universitario Rio Hortega
Valladolid, 47012
Argentina4 sites
APRILLUS
Buenos Aires, C1194AAO
Hospital Italiano de La Plata
La Plata, 1900
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, 5400
Centro Médico Privado de Reumatología
San Miguel de Tucumán, T4000AXL
Chile4 sites
CTR Estudios SPA
Providencia, 7500571
Dermacross
Santiago, 66901
Centro de Estudios Reumatologi
Santiago, 7501126
Biomedica
Santiago
Taiwan2 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 00833
National Taiwan University Hospital
Taipei, 10002
United Kingdom1 site
Guy's Hospital; Louise Coote Lupus Unit
London, SE1 9RT
About this study
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
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.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- GDC-0853
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0853Drug
Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
| Study group | Role | What they receive |
|---|---|---|
| GDC-0853 (200mg) BID | Experimental | Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). Receives: Drug: GDC-0853 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start9 Jan 2018
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Why it stopped: The study was ended early due to the lack of efficacy seen in the parent study GA30044.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407482
- Sponsor's protocol ID
- GA30066
- Other IDs
- 2017-001764-37, 2017
- Status last verified
- Nov 2020
- First submitted
- 15 Jan 2018
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03407482
- Acronym / sponsor ID
- GA30066
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was ended early due to the lack of efficacy seen in the parent study GA30044.
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDC-0853 (200mg) BID | Experimental | Drug: GDC-0853Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID). |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0853Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above. | Drug | GDC-0853 (200mg) BID |
Primary outcome
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.
5 secondary outcomes
Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48
Time frame: 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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
53 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GDC-0853 in people with Lupus Erythematosus, Systemic, run by Genentech, Inc. at 53 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Brazil, Bulgaria, Colombia, Mexico and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.