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.
- Conditions
- LupusSystemic Lupus Erythematosus10010761
- Registration Number
- NL-OMON51320
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Incidence of TEAEs - Number of Participants with Treatment Emergent Adverse<br /><br>Events (TEAEs)<br /><br>- Incidence of SAEs - Number of Participants with Serious Adverse Events (SAEs) </p><br>
- Secondary Outcome Measures
Name Time Method