Clinical trial NCT04835441: ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
Official title: A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: CD28
ICOS
Autoimmune disease
Immune system disease
Immunosuppressive agent
Lead sponsor: Alpine Immune Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is Phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of ALPN-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (SLE)


Eligibility criteria: 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 Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
* Standard lupus medications must be stable prior to Screening

Key Exclusion Criteria Summary:

* Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
* 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

Primary outcomes:
measure: Adverse Events
timeFrame: From study Day 1 until End of Study (28 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigational Site (107)
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site (189)
state: Arizona
city: Los Angeles
country: United States
facility: Investigational Site (155)
state: California
city: San Diego
country: United States
facility: Investigational Site (109)
state: California
city: Santa Barbara
country: United States
facility: Investigational Site (169)
state: California
city: DeBary
country: United States
facility: Investigational Site (106)
state: Florida
city: Hialeah
country: United States
facility: Investigational Site (120)
state: Florida
city: Miami
country: United States
facility: Investigational Sites (134)
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site (152)
state: Florida
city: Plantation
country: United States
facility: Investigational Site (133)
state: Florida
city: Tamarac
country: United States
facility: Investigational Site (190)
state: Florida
city: Tampa
country: United States
facility: Investigational Site (163)
state: Florida
city: Idaho Falls
country: United States
facility: Investigational Site (173)
state: Idaho
city: Skokie
country: United States
facility: Investigational Site (156)
state: Illinois
city: Grand Blanc
country: United States
facility: Investigational Site (138)
state: Michigan
city: Las Vegas
country: United States
facility: Investigational Site (164)
state: Nevada
city: Brooklyn
country: United States
facility: Investigational Site (175)
state: New York
city: Manhasset
country: United States
facility: Investigational Site (115)
state: New York
city: Charlotte
country: United States
facility: Investigational Site (179)
state: North Carolina
city: Crossville
country: United States
facility: Investigational Site (112)
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site (186)
state: Tennessee
city: Baytown
country: United States
facility: Investigational Site (171)
state: Texas
city: Bellaire
country: United States
facility: Investigational Site (143)
state: Texas
city: Colleyville
country: United States
facility: Investigational Site (118)
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site (166)
state: Texas
city: Houston
country: United States
facility: Investigational Site (121)
state: Texas
city: Mesquite
country: United States
facility: Investigational Site (104)
state: Texas
city: San Antonio
country: United States
facility: Investigational Site (162)
state: Texas
city: San Antonio
country: United States
facility: Investigational Site (127)
state: Texas
city: Marseille
country: France
facility: Investigational Site (149)
city: Paris
country: France
facility: Investigational Site (128)
city: Paris
country: France
facility: Investigational Site (161)
city: Budapest
country: Hungary
facility: Investigational Site (181)
city: Gyula
country: Hungary
facility: Investigational Site (180)
city: Székesfehérvár
country: Hungary
facility: Investigational Site (183)
city: Elbląg
country: Poland
facility: Investigational Site (160)
city: Kraków
country: Poland
facility: Investigational Site (110)
city: Poznań
country: Poland
facility: Investigational Site (108)
city: Poznań
country: Poland
facility: Investigational Site (119)
city: Wrocław
country: Poland
facility: Investigational Site (165)
city: Caguas
country: Puerto Rico
facility: Investigational Site (191)
city: San Juan
country: Puerto Rico
facility: Investigational Site (187)
city: Coruna
country: Spain
facility: Investigational Site (137)
city: Sevilla
country: Spain
facility: Investigational Site (139)
city: Taichung
country: Taiwan
facility: Investigational Site (184)
city: Taipei
country: Taiwan
facility: Investigational Site (182)
Study officials:
affiliation: Alpine Immune Sciences, Inc.
name: Rachel Peterson, MD
role: STUDY_DIRECTOR
References: