An 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

• Register: EUCTR
• Last refreshed on: 20 July 2020
• Main ID: EUCTR2017-001764-37-BG
• Date of registration: 16/10/2017
• Prospective Registration: Yes
• Primary sponsor: Genentech, Inc.
• Public title: An 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
• Scientific 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
• Date of first enrolment: 15/12/2017
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001764-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Korea, Republic of, Mexico, Portugal, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Age 18-76 years
- 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
- For women of childbearing potential: agreement to remain abstinent 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
- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm resulting 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion criteria:
- 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
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: GDC-0853
Product Code: RO7010939/F13
Pharmaceutical Form: Tablet
INN or Proposed INN: not available yet
CAS Number: 1434048-34-6
Current Sponsor code: GDC-0853, RO7010939
Other descriptive name: GDC-0853 RO7010939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: •To evaluate the clinical efficacy of GDC-0853 in combination with standard of care over time
•To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach

Primary end point(s): 1.The nature, frequency, severity, and timing of adverse events
2.Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC 0853 administration

Timepoint(s) of evaluation of this end point: 1-2. Up to 56 weeks

Main Objective: •To evaluate the long-term safety of GDC-0853 over an extended treatment period of up to 48 weeks

Secondary Outcome(s)

Secondary end point(s): 1.SLE Responder Index -4 response up to Week 48
2.Steady-state PK parameters such as area under the concentration–time curve from time 0 to time t (AUC0-t), Ctrough, half-life (t1/2), and apparent clearance (CL/F)

Timepoint(s) of evaluation of this end point: 1.Up to Week 48
2.Baseline (Day 1), Week 24, Week 48, at unscheduled visit, flare visit and early terminate

Secondary ID(s)

2017-001764-37-GB

GA30066

Source(s) of Monetary Support

Genentech Inc. c/o F. Hoffman-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 23/11/2017
Contact: