Phase 3 Long-term Extension Study to Evaluate BIIB059 in Active SLE

JRCT ID: jRCT2031220439

Registered date:04/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 27/02/2023
• Target sample size: 864
• Countries of recruitment: United States,Japan,Canada,Japan,Colombia,Japan,Puerto Rico,Japan,Argentina,Japan,United Kingdom,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Serbia,Japan,Czech,Japan,Germany,Japan,Hugary,Japan,Belgium,Japan,Romania,Japan,China,Japan,Australia,Japan,Brazil,Japan,Bulgaria,Japan,Chile,Japan,France,Japan,Greece,Japan,South Korea,Japan,Mexico,Japan,Peru,Japan,Philippines,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Research Name: BIIB059
Generic Name: Not applicable
Trade Names: Not applicable
Participants who were receiving background nonbiologic lupus SOC therapy and placebo in the parent Phase 3 study will be randomized 1:1 to receive BIIB059 high dose and BIIB059 low dose SC Q4W up to 152 weeks with an additional corresponding dose at Week 2. Participants who were receiving BIIB059 high dose and BIIB059 low dose SC Q4W in the parent Phase 3 studies will continue using the same dose, respectively, up to 152 weeks with an additional dose of placebo at Week 2.

Outcome(s)

Primary Outcome

-Incidence of TEAEs

-Incidence of SAEs

Secondary Outcome

-Proportion of participants who achieved an SRI-4 response

-Proportion of participants who achieved a Joint-50 response

-Proportion of participants who achieved CLASI-50, CLASI 70, and CLASI 90 response

-Proportion of participants who achieved a BICLA response

-Annualized severe SFI Flare Rate where severe flare is defined using the SFI definition

-Percentage of time spent in LLDAS

-Duration of sustained LLDAS as defined by the number of visits in LLDAS

-Annual change from baseline value from the parent Phase 3 studies in SDI score

-Cumulative exposure to OCS over time

-Proportion of participants with OCS <= 7.5 mg

-Proportion of participants with OCS <= 5 mg

-LupusQoL, SF-36 (Acute Version), FACIT-Fatigue, PHQ 9, WPAI:Lupus, and PtGA

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 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.

Exclude criteria

-Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52).

-Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period).

-Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose)

-Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.

Related Information

• Primary Sponsor: Cho Kyo
• Secondary ID(s): NCT05352919