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BIIB059

Phase 3

Subacute Cutaneous Lupus Erythematosus | Small molecule | Immunology |Biogen Inc.|Last Updated: May 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment322
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06044337A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus ErythematosusPHASE3 ENROLLING BY_INVITATION 322 — — Oct 3, 2023Dec 11, 2029May 5, 2026104 United States, Argentina +23
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 128 weeks
Secondary Endpoints
Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Up to 128 weeks
Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Up to 128 weeks
Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Improvement in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])
Up to 128 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BIIB059EXPERIMENTALParticipants will receive BIIB059 (litifilimab) subcutaneously (SC), once every 4 weeks up to Week 100 in the LTE period. Following the 2 year long-term extension (LTE) period, participants in the USA will receive BIIB059 (litifilimab), once every 4 weeks up to Week 256.
Interventions
NameTypeDescription
BIIB059 (litifilimab)DRUGAdministered as specified in the treatment arm.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites104

Key Inclusion Criteria: * Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52). * Ability of the participant to understand the purpose and risks of the...

Countries:United StatesArgentinaBrazilBulgariaCanadaChileChinaColombiaFranceGermanyHungaryItalyJapanMexicoPhilippinesPolandPortugalSerbiaSlovakiaSouth KoreaSpainSwedenSwitzerlandTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06044337primaryCompletionDate: changed
LOWMay 24, 2026NCT06044337studyFirstPostDate: changed