ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— Synergy  

Official title:

A Randomized, Double-blind, Placebo-controlled Study of ALPN-101 in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04835441
• Other study ID #: AIS-A03
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 22, 2021
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Alpine Immune Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• ALPN-101
Blinded ALPN-101 will be administered
• Placebo
Blinded placebo matching ALPN-101 will be administered.

Locations

Country	Name	City	State
France	Investigational Site (149)	Marseille
France	Investigational Site (128)	Paris
France	Investigational Site (161)	Paris
Hungary	Investigational Site (181)	Budapest
Hungary	Investigational Site (180)	Gyula
Hungary	Investigational Site (183)	Székesfehérvár
Poland	Investigational Site (160)	Elblag
Poland	Investigational Site (110)	Kraków
Poland	Investigational Site (108)	Poznan
Poland	Investigational Site (119)	Poznan
Poland	Investigational Site (165)	Wroclaw
Puerto Rico	Investigational Site (191)	Caguas
Puerto Rico	Investigational Site (187)	San Juan
Spain	Investigational Site (137)	Coruna
Spain	Investigational Site (139)	Sevilla
Taiwan	Investigational Site (184)	Taichung
Taiwan	Investigational Site (182)	Taipei
United States	Investigational Site (107)	Anniston	Alabama
United States	Investigational Site (171)	Baytown	Texas
United States	Investigational Site (143)	Bellaire	Texas
United States	Investigational Site (175)	Brooklyn	New York
United States	Investigational Site (179)	Charlotte	North Carolina
United States	Investigational Site (118)	Colleyville	Texas
United States	Investigational Site (112)	Crossville	Tennessee
United States	Investigational Site (106)	DeBary	Florida
United States	Investigational Site (166)	Fort Worth	Texas
United States	Investigational Site (138)	Grand Blanc	Michigan
United States	Investigational Site (120)	Hialeah	Florida
United States	Investigational Site (121)	Houston	Texas
United States	Investigational Site (173)	Idaho Falls	Idaho
United States	Investigational Site (164)	Las Vegas	Nevada
United States	Investigational Site (155)	Los Angeles	California
United States	Investigational Site (115)	Manhasset	New York
United States	Investigational Site (186)	Memphis	Tennessee
United States	Investigational Site (104)	Mesquite	Texas
United States	Investigational Sites (134)	Miami	Florida
United States	Investigational Site (152)	Ormond Beach	Florida
United States	Investigational Site (189)	Phoenix	Arizona
United States	Investigational Site (133)	Plantation	Florida
United States	Investigational Site (127)	San Antonio	Texas
United States	Investigational Site (162)	San Antonio	Texas
United States	Investigational Site (109)	San Diego	California
United States	Investigational Site (169)	Santa Barbara	California
United States	Investigational Site (156)	Skokie	Illinois
United States	Investigational Site (190)	Tamarac	Florida
United States	Investigational Site (163)	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Immune Sciences, Inc.

Countries where clinical trial is conducted

United States,  France,  Hungary,  Poland,  Puerto Rico,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Type, incidence, and severity of adverse events as assessed by CTCAE	From study Day 1 until End of Study (28 weeks)