Lupus Systemic Lupus Erythematosus
Conditions
Interventions
In this LTE study, participants who received randomized low dose BIIB059 and
high dose BIIB059 SC Q4W during the parent Phase 3 studies will continue their
respective doses. There will be no placebo
Sponsors
Biogen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52. 2. Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations. 3. All women of childbearing potential must agree to practice highly effective contraception during the study and for 126 days (18 weeks) after their last dose of study treatment. In addition, participants should not donate eggs during the study and for at least 126 days (18 weeks) after their last dose of study treatment. Where applicable, if not previously confirmed in the parent Phase 3 study, postmenopausal status must be confirmed as follows: for women = 40 mIU/mL; for women > 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level >= 40 mIU/mL, or at least 5 continuous years of natural (spontaneous) amenorrhea without an alternative medical cause.
Exclusion criteria
Exclusion criteria: 1. Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52). 2. Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-week treatment period). 3. Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the LTE study unsuitable in the opinion of the Investigator. 4. Participants who developed moderate-to-severe worsening of organ specific lupus manifestations that would require a change in immunosuppressive therapy. 5. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies. 6. Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit. 7. Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies. 8. Female participants who are pregnant, currently breastfeeding, or planning to become pregnant during the study and for 126 days (18 weeks) after the last dose of study treatment. 9. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered (participation in observational registries is allowed). 10. Inability to comply with study requirements. 11. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of TEAEs - Number of Participants with Treatment Emergent Adverse Events (TEAEs) - Incidence of SAEs - Number of Participants with Serious Adverse Events (SAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response by visit - Proportion of Participants who Achieved a Joint-50 Response by visit - Proportion of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response by visit - Proportion of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response by visit - Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate where severe flare is defined using the SFI definition (Appendix B of the Protocol) - Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS) - Proportion of participants with sustained LLDAS - Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS up to Week 180 - Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score - Cumulative Exposure to OCS Over Time - Percentage of Participants With OCS | — |
Countries
Netherlands
Outcome results
None listed