A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults with Active Systemic Lupus Erythematosus (EMERALD)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 864

Inclusion Criteria

Key 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 = 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea without an alternative medical cause and a serum FSH level = 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.
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 844
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Key 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus.

Phase 3

Biogen

Updated 6/18/2024