ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
NCT ID: NCT04835441
Last Updated: 2025-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2021-06-22
2024-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALPN-101 (Acazicolcept)
Participants received a weight-based dose of 3 milligrams/kilogram (mg/kg) ALPN-101 once every 2 weeks (Q2W) up to 24 weeks.
ALPN-101
Intravenous infusion via an infusion pump.
Placebo
Participants received placebo matched to ALPN-101 up to 24 weeks.
Placebo
Intravenous infusion via an infusion pump.
Interventions
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ALPN-101
Intravenous infusion via an infusion pump.
Placebo
Intravenous infusion via an infusion pump.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
* Standard lupus medications must be stable prior to Screening
Exclusion Criteria
* Proteinuria consistent with nephrotic syndrome
* Active lupus-related neuropsychiatric disease
* Drug-induced lupus
* Recent or serious ongoing infection; risk or history of serious infection
* Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
* Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
* Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
* Functional class IV
* Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
18 Years
70 Years
ALL
No
Sponsors
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Alpine Immune Sciences Inc, A Subsidiary of Vertex
INDUSTRY
Responsible Party
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Locations
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Investigational Site (107)
Anniston, Alabama, United States
Investigational Site (189)
Phoenix, Arizona, United States
Investigational Site (155)
Los Angeles, California, United States
Investigational Site (109)
San Diego, California, United States
Investigational Site (169)
Santa Barbara, California, United States
Investigational Site (106)
DeBary, Florida, United States
Investigational Site (120)
Hialeah, Florida, United States
Investigational Sites (134)
Miami, Florida, United States
Investigational Site (152)
Ormond Beach, Florida, United States
Investigational Site (133)
Plantation, Florida, United States
Investigational Site (190)
Tamarac, Florida, United States
Investigational Site (163)
Tampa, Florida, United States
Investigational Site (173)
Idaho Falls, Idaho, United States
Investigational Site (156)
Skokie, Illinois, United States
Investigational Site (138)
Grand Blanc, Michigan, United States
Investigational Site (164)
Las Vegas, Nevada, United States
Investigational Site (175)
Brooklyn, New York, United States
Investigational Site (115)
Manhasset, New York, United States
Investigational Site (179)
Charlotte, North Carolina, United States
Investigational Site (112)
Crossville, Tennessee, United States
Investigational Site (186)
Memphis, Tennessee, United States
Investigational Site (171)
Baytown, Texas, United States
Investigational Site (143)
Bellaire, Texas, United States
Investigational Site (118)
Colleyville, Texas, United States
Investigational Site (166)
Fort Worth, Texas, United States
Investigational Site (121)
Houston, Texas, United States
Investigational Site (104)
Mesquite, Texas, United States
Investigational Site (162)
San Antonio, Texas, United States
Investigational Site (127)
San Antonio, Texas, United States
Investigational Site (149)
Marseille, , France
Investigational Site (128)
Paris, , France
Investigational Site (161)
Paris, , France
Investigational Site (181)
Budapest, , Hungary
Investigational Site (180)
Gyula, , Hungary
Investigational Site (183)
Székesfehérvár, , Hungary
Investigational Site (160)
Elblag, , Poland
Investigational Site (110)
Krakow, , Poland
Investigational Site (108)
Poznan, , Poland
Investigational Site (119)
Poznan, , Poland
Investigational Site (165)
Wroclaw, , Poland
Investigational Site (191)
Caguas, , Puerto Rico
Investigational Site (187)
San Juan, , Puerto Rico
Investigational Site (137)
A Coruña, , Spain
Investigational Site (139)
Seville, , Spain
Investigational Site (184)
Taichung, , Taiwan
Investigational Site (182)
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AIS-A03
Identifier Type: -
Identifier Source: org_study_id
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