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

This open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in patients with moderate to severe active systemic lupus erythematosus (SLE).

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

• Signed Informed Consent Form (see Section 4.4.1)
• 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.
GDC-0853—Genentech, Inc.
37/ Protocol GA30066, Version 1
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below (also see Appendix 5)
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.

Primary disease category: Arthritis

Sponsor: Genentech, Inc.

Projected enrollment dates: January 2018 to June 2019

Official study 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