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A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GDC-0853

Placebo

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
Stable doses of anti-malarial or immunosuppressive therapies
Participants must be willing to avoid pregnancy

Exclusion Criteria:

Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
Neuropsychiatric or central nervous system lupus manifestations
Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
History of receiving a solid organ transplant
Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
Evidence of chronic and/or active hepatitis B or C

Sites / Locations

University of Alabama at Birmingham
Valerius Medical Group & Research Ctr of Greater Long Beach
RASF-Clinical Research Center
Bay Area Arthritis and Osteoporosis
Omega Research Consultants
Clinical Research of West Florida
Institute of Arthritis Research
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Ochsner Clinic Foundation
The Arthritis & Diabetes Clinic, Inc.; Research
Albuquerque Clinical Trials
Saint Lawrence Health System
New York University School of Medicine
Shanahan Rheumatology & Immunology, PLLC
Ohio State University Clinical Trials Management Office
Tekton Research Inc
Accurate Clinical Research
Accurate Clinical Research
Arthritis Clinic Of Central Texas
Organizacion Medica de Investigacion
APRILLUS
Hospital Italiano de La Plata
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
Centro Medico Privado de Reumatologia; Reumathology
CEDOES - Diagnóstico e Pesquisa
CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
Hospital das Clinicas - UFMG
CMiP - Centro Mineiro de Pesquisa*X*
Edumed - Educação e Saúde SA
Hospital Moinhos de Vento
Centro de Pesquisas em Diabetes - CPD
Clinica de Neoplasias Litoral
Faculdade de Medicina do ABC - FMABC
Hospital Estadual Mario Covas
Hospital Abreu Sodré - AACD
MHAT Plovdiv
Medical Center "Teodora", EOOD
Medical Center Excelsior OOD
UMHAT "Sv. Ivan Rilski", EAD
MC "Synexus - Sofia", EOOD
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
CTR Estudios SPA
Dermacross
Centro de Estudios Reumatológicos
SOMEAL
Biomedica
CEQUIN - Fundación Cardiomet Eje Cafetero
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Centro de Reumatologia y Ortopedia
Medicity S.A.S.
Servimed S.A.S.
Hospital Pablo Tobon Uribe
Charite Research Organisation GmbH; Phase - I Unit of Hematology and Oncology
Konkuk University Medical Center
The Catholic University of Korea St.Mary's Hospital
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Unidad de Atencion Medica e Investigacion en Salud S.C.
Consultorio Particular del Dr. Miguel Cortes Hernandez
Hospital Angeles Lindavista
Hospital Universitario de Saltillo
Hospital Central Dr Ignacio Morones Prieto
Complejo Hospitalario Universitario A Coruña
Hospital Universitari Vall d'Hebron
Hospital General Universitario Gregorio Marañon
Hospital Clinico Universitario de Valladolid; Servicio de Reumatologia
Kaohsiung Chang Gung Memorial Hospital
National Taiwan University Hospital
Chang Gung Memorial Hospital - Linkou
University College London Hospital
Guy's Hospital; Louise Coote Lupus Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

GDC-0853 (150mg) QD

GDC-0853 (200mg) BID

Arm Description

Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Outcomes

Primary Outcome Measures

Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at 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.

Secondary Outcome Measures

SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48

The 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. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].

SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24

The 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. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].

SRI-4 Response at Week 24

SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels

The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels

The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

SRI-6 Response at Week 24 and 48

The Systemic Lupus Erythematosus Responder Index (SRI)-6 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 ≥6 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.

BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48

The BICLA is a composite index that is defined as follows: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=<10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).

Percentage of Participants With Adverse Events (AEs)

An Adverse Event 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 an abnormal laboratory finding, for example), 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.

Plasma Concentrations of Fenebrutinib at Specified Timepoints

The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.

Full Information

NCT ID

NCT02908100

First Posted

September 14, 2016

Last Updated

June 22, 2020

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02908100

Brief Title

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

Official Title

A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

May 28, 2019 (Actual)

Study Completion Date

July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Arm Title

GDC-0853 (150mg) QD

Arm Type

Experimental

Arm Description

Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Arm Title

GDC-0853 (200mg) BID

Arm Type

Experimental

Arm Description

Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy.

Intervention Type

Drug

Intervention Name(s)

GDC-0853

Other Intervention Name(s)

RO7010939

Intervention Description

Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.

Primary Outcome Measure Information:

Title

Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48

Description

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Description

Time Frame

Week 48

Title

SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24

Description

The 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. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].

Time Frame

Week 24

Title

SRI-4 Response at Week 24

Description

Time Frame

Week 24

Title

SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels

Description

The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

Time Frame

Week 48

Title

SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels

Description

The 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. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.

Time Frame

Week 48

Title

SRI-6 Response at Week 24 and 48

Description

Time Frame

Week 24, 48

Title

BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48

Description

Time Frame

Week 24, 48

Title

Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to 8 weeks after the last dose of study drug (up to Week 56).

Title

Plasma Concentrations of Fenebrutinib at Specified Timepoints

Description

Time Frame

Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent) Stable doses of anti-malarial or immunosuppressive therapies Participants must be willing to avoid pregnancy Exclusion Criteria: Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period) History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1 Neuropsychiatric or central nervous system lupus manifestations Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy History of receiving a solid organ transplant Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation History of cancer, including hematological malignancy and solid tumors, within 10 years of screening Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents Evidence of chronic and/or active hepatitis B or C

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Valerius Medical Group & Research Ctr of Greater Long Beach

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

RASF-Clinical Research Center

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Bay Area Arthritis and Osteoporosis

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Omega Research Consultants

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

Clinical Research of West Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Ochsner Clinic Foundation

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

The Arthritis & Diabetes Clinic, Inc.; Research

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Albuquerque Clinical Trials

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Saint Lawrence Health System

City

Canton

State/Province

New York

ZIP/Postal Code

13617

Country

United States

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Shanahan Rheumatology & Immunology, PLLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

Ohio State University Clinical Trials Management Office

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Tekton Research Inc

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77058-3675

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

Arthritis Clinic Of Central Texas

City

San Marcos

State/Province

Texas

ZIP/Postal Code

78666

Country

United States

Facility Name

Organizacion Medica de Investigacion

City

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

APRILLUS

City

Buenos Aires

ZIP/Postal Code

C1194AAO

Country

Argentina

Facility Name

Hospital Italiano de La Plata

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

Centro Medico Privado de Reumatologia; Reumathology

City

San Miguel

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

CEDOES - Diagnóstico e Pesquisa

City

Vitoria

State/Province

ZIP/Postal Code

29055-450

Country

Brazil

Facility Name

CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica

City

Goiânia

State/Province

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

Hospital das Clinicas - UFMG

City

Belo Horizonte

State/Province

ZIP/Postal Code

31270-901

Country

Brazil

Facility Name

CMiP - Centro Mineiro de Pesquisa*X*

City

Juiz de Fora

State/Province

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

Edumed - Educação e Saúde SA

City

Curitiba

State/Province

ZIP/Postal Code

80440-080

Country

Brazil

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-001

Country

Brazil

Facility Name

Centro de Pesquisas em Diabetes - CPD

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Clinica de Neoplasias Litoral

City

Itajai

State/Province

ZIP/Postal Code

88301-220

Country

Brazil

Facility Name

Faculdade de Medicina do ABC - FMABC

City

Santo Andre

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Hospital Estadual Mario Covas

City

Santo Andre

State/Province

ZIP/Postal Code

09190-610

Country

Brazil

Facility Name

Hospital Abreu Sodré - AACD

City

Sao Paulo

State/Province

ZIP/Postal Code

04023-000

Country

Brazil

Facility Name

MHAT Plovdiv

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

Medical Center "Teodora", EOOD

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Medical Center Excelsior OOD

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski", EAD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

MC "Synexus - Sofia", EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

CTR Estudios SPA

City

Providencia

ZIP/Postal Code

7500571

Country

Chile

Facility Name

Dermacross

City

Santiago

ZIP/Postal Code

66901

Country

Chile

Facility Name

Centro de Estudios Reumatológicos

City

Santiago

ZIP/Postal Code

7501126

Country

Chile

Facility Name

SOMEAL

City

Santiago

ZIP/Postal Code

7510186

Country

Chile

Facility Name

Biomedica

City

Santiago

Country

Chile

Facility Name

CEQUIN - Fundación Cardiomet Eje Cafetero

City

Armenia

ZIP/Postal Code

00000

Country

Colombia

Facility Name

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

City

Barranquilla

ZIP/Postal Code

00000

Country

Colombia

Facility Name

Centro de Reumatologia y Ortopedia

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

Medicity S.A.S.

City

Bucaramanga

ZIP/Postal Code

680003

Country

Colombia

Facility Name

Servimed S.A.S.

City

Bucaramanga

ZIP/Postal Code

680003

Country

Colombia

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Charite Research Organisation GmbH; Phase - I Unit of Hematology and Oncology

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

The Catholic University of Korea St.Mary's Hospital

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Centro de Investigacion Alberto Bazzoni S.A. de C.V.

City

Torreon

State/Province

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Unidad de Atencion Medica e Investigacion en Salud S.C.

City

Mérida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Consultorio Particular del Dr. Miguel Cortes Hernandez

City

Cuernavaca

ZIP/Postal Code

62290

Country

Mexico

Facility Name

Hospital Angeles Lindavista

City

Mexico

ZIP/Postal Code

07760

Country

Mexico

Facility Name

Hospital Universitario de Saltillo

City

Saltillo

ZIP/Postal Code

25000

Country

Mexico

Facility Name

Hospital Central Dr Ignacio Morones Prieto

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Complejo Hospitalario Universitario A Coruña

City

A Coruña

State/Province

LA Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Clinico Universitario de Valladolid; Servicio de Reumatologia

City

Valladolid

ZIP/Postal Code

47005

Country

Spain

Facility Name

Kaohsiung Chang Gung Memorial Hospital

City

Kaohsiung City

ZIP/Postal Code

00833

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital - Linkou

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

University College London Hospital

City

London

ZIP/Postal Code

NW1 - 2PG

Country

United Kingdom

Facility Name

Guy's Hospital; Louise Coote Lupus Unit

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34042314

Citation

Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, McGregor A, Toth B, Rae J, Hwang O, Desai R, Lokku A, Ramamoorthi N, Hackney JA, Miranda P, de Souza VA, Jaller-Raad JJ, Maura Fernandes A, Garcia Salinas R, Chinn LW, Townsend MJ, Morimoto AM, Tuckwell K. Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24.

Results Reference

derived

Learn more about this trial

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

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