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ALPN-101

Phase 2

Systemic Lupus Erythematosus | Small molecule | Immunology |Vertex Pharmaceuticals Incorporated|Last Updated: Aug 15, 2025

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04835441ALPN-101 (Acazicolcept) in Systemic Lupus ErythematosusPHASE2 COMPLETED 76Jun 22, 2021Jul 9, 2024Aug 15, 202546 United States, France +5
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Study Endpoints
Primary Endpoints
Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Day 1 up to Safety follow-up (up to 28 weeks)
Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
At Day 169

The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index, and the Physician's Global Assessment (PGA). Participants classified as responder if they met all of the following criteria: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) No worsening from baseline in participants' lupus disease activity (i.e., increase of ≥0.3 0 on a 3-point scale) in PGA. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A\[severe\] to E\[no disease\]). PGA: assesses worsening in participant's general health.

Percentage of Participants Achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response
At Day 169

The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B \[mild disease\] scores falling to C \[Stable and mild\], or D \[no activity\]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score. The PGA is measured on a 0 to 100 mm scale with score 0 indicates No Disease Activity and score 100 indicates the most Severe Disease Activity.

Secondary Endpoints
Annualized Flare Rate by British Isles Lupus Assessment Group (BILAG)-2004 Flare Index
From Baseline to Day 169
Time-to-first Flare by BILAG-2004 Flare Index
From Baseline to Day 169
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
At Day 169
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALPN-101 (Acazicolcept)EXPERIMENTALParticipants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
PlaceboPLACEBO_COMPARATORParticipants received placebo matched to ALPN-101 up to 24 weeks.
Interventions
NameTypeDescription
ALPN-101DRUGIntravenous infusion via an infusion pump.
PlaceboDRUGIntravenous infusion via an infusion pump.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites46

Key Inclusion Criteria Summary * SLE onset ≥ 6 months prior to Screening * Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test * Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Scr...

Countries:United StatesFranceHungaryPolandPuerto RicoSpainTaiwan
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