Clinical Trials List
Protocol NumberGA30066
NCT Number(ClinicalTrials.gov Identfier)NCT03407482
2018-03-31 - 2023-12-30
Phase II
Terminated6
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-10M32
Systemic lupus erythematosus (SLE)
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Genentech Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 洪偉哲 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Yao-Fan Fang 風濕免疫科
- Ping-Han Tsai 風濕免疫科
- Shue-Fen Lo 風濕免疫科
- 陳彥輔 風濕免疫科
- TianMing Zhan 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Principal Investigator
Co-Principal Investigator
- Wen Chan Tsai 未分科
Audit
None
Co-Principal Investigator
- 郭佑民 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
- SONG-CHOU HSIEH 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- 歐燦騰 風濕免疫科
- 吳正欽 風濕免疫科
- Jeng-Hsien Yen 風濕免疫科
- Sung Wan-Yu 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Moderate to Severe Active Systemic Lupus Erythematosus
Objectives
Primary Objective (Safety)
• To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 48 weeks
Secondary Objective (Efficacy)
• To evaluate the clinical efficacy of GDC-0853 in combination with SOC over time
Exploratory Efficacy Objectives
• To evaluate if GDC-0853 leads to decreased steroid usage and is steroid sparing
• To evaluate the ability of GDC-0853 to prolong the time to first SLE flare and reduce the number of total SLE flares
Test Drug
GDC-0853
Active Ingredient
GDC-0853
Dosage Form
tablet
Dosage
50
Endpoints
Primary Outcome Measures :
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.
Secondary Outcome Measures :
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.
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).
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).
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.
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.
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.
Secondary Outcome Measures :
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.
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).
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).
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.
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.
Inclution Criteria
Inclusion Criteria
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age 18−76 years, inclusive, at time of signing Informed Consent Form
• 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
• Women of childbearing potential must have a negative urine pregnancy test at baseline
A serum pregnancy test is needed on Day 1 only if the urine pregnancy test is positive.
• For women of childbearing potential (including those who have had a tubal ligation):
Agreement to remain abstinent (refrain from heterosexual intercourse) or use a
contraceptive method with a failure rate of < 1% per year during the treatment period and for
at least 60 days after the last dose of study drug.
A woman is considered to be of childbearing potential if she is postmenarcheal, has
not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no
identified cause other than menopause), and has not undergone surgical sterilization
(removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, established proper use of hormonal
contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and
copper intrauterine devices. Women using estrogen-containing hormonal
contraceptives as a method of contraception must also use a barrier, such as a male
condom, in conjunction with the hormonal contraceptives.
The reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal
are not acceptable methods of contraception.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm, as defined below
Men with female partners of childbearing potential (including those who have had a
tubal ligation) must remain abstinent or use a condom plus an additional contraceptive
method that together result in a failure rate of < 1% per year during the treatment
period and for at least 120 days (4 months) after the last dose of study treatment. Men
must refrain from donating sperm during this same period.
Men with pregnant female partners must remain abstinent or use a condom during the
treatment period and for at least 28 days after the last dose of study treatment to avoid
exposing the embryo.
The reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal
are not acceptable methods of contraception.
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age 18−76 years, inclusive, at time of signing Informed Consent Form
• 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
• Women of childbearing potential must have a negative urine pregnancy test at baseline
A serum pregnancy test is needed on Day 1 only if the urine pregnancy test is positive.
• For women of childbearing potential (including those who have had a tubal ligation):
Agreement to remain abstinent (refrain from heterosexual intercourse) or use a
contraceptive method with a failure rate of < 1% per year during the treatment period and for
at least 60 days after the last dose of study drug.
A woman is considered to be of childbearing potential if she is postmenarcheal, has
not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no
identified cause other than menopause), and has not undergone surgical sterilization
(removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, established proper use of hormonal
contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and
copper intrauterine devices. Women using estrogen-containing hormonal
contraceptives as a method of contraception must also use a barrier, such as a male
condom, in conjunction with the hormonal contraceptives.
The reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal
are not acceptable methods of contraception.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm, as defined below
Men with female partners of childbearing potential (including those who have had a
tubal ligation) must remain abstinent or use a condom plus an additional contraceptive
method that together result in a failure rate of < 1% per year during the treatment
period and for at least 120 days (4 months) after the last dose of study treatment. Men
must refrain from donating sperm during this same period.
Men with pregnant female partners must remain abstinent or use a condom during the
treatment period and for at least 28 days after the last dose of study treatment to avoid
exposing the embryo.
The reliability of sexual abstinence should be evaluated in relation to the duration of
the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal
are not acceptable methods of contraception.
Exclusion Criteria
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
• Met protocol-defined treatment-stopping criteria during Study GA30044
• An adverse event in Study GA30044 that required permanent discontinuation of study drug
• During Study GA30044, treatment with any therapy that is prohibited in this study
• In the opinion of the investigator, any new (since initially enrolling in the Phase II
Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related
to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the
patient at undue risk from a safety perspective
If the Principal Investigator has questions related to exclusion, he or she should consult
the Medical Monitor.
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 60
days after the last dose of study drug
• Any uncontrolled or clinically significant laboratory abnormality that would affect safety,
interpretation of study data, or the patient’s participation in the study in the opinion of the
investigator in consultation with the Medical Monitor
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics
within the last 4 weeks of Study GA30044
• Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
(TB) as defined as follows:
– A positive QuantiFERON−TB Gold (QFT) or T-SPOT TB test or a Mantoux purified
protein derivative (PPD) skin test (performed per Centers for Disease Control and
Prevention [CDC] guidelines using 5 tuberculin units per 0.1 mL) result of ≥ 5 mm of
induration, performed at the Week 44 visit of Study GA30044 or later, prior to entry into
Study GA30066
– Patients with a history of bacillus Calmette-Guérin vaccination should be screened
using the QFT test only.
– A positive QFT test should be considered a positive diagnostic TB test.
– If initial QFT is indeterminate, perform a confirmatory test with either QFT or T-SPOT.
The Principal Investigator may consult with the Medical Monitor to discuss selection of
confirmatory test based on the patient’s disease status and baseline immunosuppression.
– An indeterminate QFT test followed by a negative QFT or negative T-SPOT test should
be considered a negative diagnostic TB test.
– An indeterminate QFT test followed by an indeterminate QFT test or borderline or
positive T-SPOT test should be considered a positive diagnostic TB test.
• Patients who experienced a de novo or reactivated serious viral infection, such as hepatitis
B virus or hepatitis C virus (HCV) during Study GA30044
Positive hepatitis B surface antigen (HBsAg) or hepatitis C serology (regardless of
treatment status) or positive hepatitis B core antibody (HBcAb) (tested at Week 44 of
Study GA30044 or later, prior to entry into Study GA30066) are exclusionary • Patients who developed a malignancy (with the exception of non-serious local and
resectable basal or squamous cell carcinoma of the skin) during the Phase II Study GA30044
• 12-lead ECG at the Week 48 visit of Study GA30044 that demonstrates clinically relevant
abnormalities that may affect patient safety or interpretation of study results, including the following:
QTcF > 440 msec demonstrated by at least two ECGs > 30 minutes apart
• Current treatment with medications that are well known to prolong the QT interval at
doses that have a clinically meaningful effect on QT, as determined by the investigator
The investigator may contact the Sponsor for confirmation if needed. The investigator
may reference the CredibleMeds Web site:
https://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf.
• Estimated glomerular-filtration rate (based on the 4-variable Modification of Diet in Renal
Disease equation) < 30 mL/min or on chronic renal replacement therapy
• Laboratory values from the Week 44 visit of Study GA30044 (which may be repeated once
at a later unscheduled visit, if necessary) that meet the following criteria:
– AST or ALT > 1.5 × ULN (unless due to known autoimmune hepatitis)
– Total bilirubin > 1.2 ULN
– Amylase or lipase > 2 × ULN
– Hemoglobin < 7 g/dL
– ANC < 1.5 × 109 /L
– Absolute lymphocyte count (ALC) < 0.5 × 109/L
– Platelet count < 50,000/μL
Patients who meet any of the following criteria will be excluded from study entry:
• Met protocol-defined treatment-stopping criteria during Study GA30044
• An adverse event in Study GA30044 that required permanent discontinuation of study drug
• During Study GA30044, treatment with any therapy that is prohibited in this study
• In the opinion of the investigator, any new (since initially enrolling in the Phase II
Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related
to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the
patient at undue risk from a safety perspective
If the Principal Investigator has questions related to exclusion, he or she should consult
the Medical Monitor.
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 60
days after the last dose of study drug
• Any uncontrolled or clinically significant laboratory abnormality that would affect safety,
interpretation of study data, or the patient’s participation in the study in the opinion of the
investigator in consultation with the Medical Monitor
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics
within the last 4 weeks of Study GA30044
• Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
(TB) as defined as follows:
– A positive QuantiFERON−TB Gold (QFT) or T-SPOT TB test or a Mantoux purified
protein derivative (PPD) skin test (performed per Centers for Disease Control and
Prevention [CDC] guidelines using 5 tuberculin units per 0.1 mL) result of ≥ 5 mm of
induration, performed at the Week 44 visit of Study GA30044 or later, prior to entry into
Study GA30066
– Patients with a history of bacillus Calmette-Guérin vaccination should be screened
using the QFT test only.
– A positive QFT test should be considered a positive diagnostic TB test.
– If initial QFT is indeterminate, perform a confirmatory test with either QFT or T-SPOT.
The Principal Investigator may consult with the Medical Monitor to discuss selection of
confirmatory test based on the patient’s disease status and baseline immunosuppression.
– An indeterminate QFT test followed by a negative QFT or negative T-SPOT test should
be considered a negative diagnostic TB test.
– An indeterminate QFT test followed by an indeterminate QFT test or borderline or
positive T-SPOT test should be considered a positive diagnostic TB test.
• Patients who experienced a de novo or reactivated serious viral infection, such as hepatitis
B virus or hepatitis C virus (HCV) during Study GA30044
Positive hepatitis B surface antigen (HBsAg) or hepatitis C serology (regardless of
treatment status) or positive hepatitis B core antibody (HBcAb) (tested at Week 44 of
Study GA30044 or later, prior to entry into Study GA30066) are exclusionary • Patients who developed a malignancy (with the exception of non-serious local and
resectable basal or squamous cell carcinoma of the skin) during the Phase II Study GA30044
• 12-lead ECG at the Week 48 visit of Study GA30044 that demonstrates clinically relevant
abnormalities that may affect patient safety or interpretation of study results, including the following:
QTcF > 440 msec demonstrated by at least two ECGs > 30 minutes apart
• Current treatment with medications that are well known to prolong the QT interval at
doses that have a clinically meaningful effect on QT, as determined by the investigator
The investigator may contact the Sponsor for confirmation if needed. The investigator
may reference the CredibleMeds Web site:
https://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf.
• Estimated glomerular-filtration rate (based on the 4-variable Modification of Diet in Renal
Disease equation) < 30 mL/min or on chronic renal replacement therapy
• Laboratory values from the Week 44 visit of Study GA30044 (which may be repeated once
at a later unscheduled visit, if necessary) that meet the following criteria:
– AST or ALT > 1.5 × ULN (unless due to known autoimmune hepatitis)
– Total bilirubin > 1.2 ULN
– Amylase or lipase > 2 × ULN
– Hemoglobin < 7 g/dL
– ANC < 1.5 × 109 /L
– Absolute lymphocyte count (ALC) < 0.5 × 109/L
– Platelet count < 50,000/μL
The Estimated Number of Participants
-
Taiwan
3 participants
-
Global
160 participants
