ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: ALPN-101; Drug: Placebo

• Registration Number: NCT04835441
• Lead Sponsor: Alpine Immune Sciences, Inc.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2021-06-22
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALPN-101 (acazicolcept)	ALPN-101	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	From study Day 1 until End of Study (28 weeks)	Type, incidence, and severity of adverse events as assessed by CTCAE

Trial Locations

Locations (46)

Investigational Site (173); 🇺🇸 Idaho Falls, Idaho, United States

Investigational Site (118); 🇺🇸 Colleyville, Texas, United States

Investigational Site (191); 🇵🇷 Caguas, Puerto Rico

Investigational Site (187); 🇵🇷 San Juan, Puerto Rico

Investigational Sites (134); 🇺🇸 Miami, Florida, United States

Investigational Site (155); 🇺🇸 Los Angeles, California, United States

Investigational Site (107); 🇺🇸 Anniston, Alabama, United States

Investigational Site (120); 🇺🇸 Hialeah, Florida, United States

Investigational Site (106); 🇺🇸 DeBary, 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 (156); 🇺🇸 Skokie, Illinois, United States

Investigational Site (138); 🇺🇸 Grand Blanc, Michigan, United States

Investigational Site (179); 🇺🇸 Charlotte, North Carolina, United States

Investigational Site (112); 🇺🇸 Crossville, Tennessee, United States

Investigational Site (161); 🇫🇷 Paris, France

Investigational Site (186); 🇺🇸 Memphis, Tennessee, United States

Investigational Site (171); 🇺🇸 Baytown, Texas, United States

Investigational Site (143); 🇺🇸 Bellaire, Texas, United States

Investigational Site (121); 🇺🇸 Houston, Texas, United States

Investigational Site (166); 🇺🇸 Fort Worth, Texas, United States

Investigational Site (149); 🇫🇷 Marseille, France

Investigational Site (183); 🇭🇺 Székesfehérvár, Hungary

Investigational Site (128); 🇫🇷 Paris, France

Investigational Site (180); 🇭🇺 Gyula, Hungary

Investigational Site (110); 🇵🇱 Kraków, Poland

Investigational Site (108); 🇵🇱 Poznań, Poland

Investigational Site (165); 🇵🇱 Wrocław, Poland

Investigational Site (137); 🇪🇸 Coruna, Spain

Investigational Site (139); 🇪🇸 Sevilla, Spain

Investigational Site (184); 🇨🇳 Taichung, Taiwan

Investigational Site (175); 🇺🇸 Brooklyn, New York, United States

Investigational Site (169); 🇺🇸 Santa Barbara, California, United States

Investigational Site (115); 🇺🇸 Manhasset, New York, United States

Investigational Site (104); 🇺🇸 Mesquite, Texas, United States

Investigational Site (182); 🇨🇳 Taipei, Taiwan

Investigational Site (119); 🇵🇱 Poznań, Poland

Investigational Site (181); 🇭🇺 Budapest, Hungary

Investigational Site (160); 🇵🇱 Elbląg, Poland

Investigational Site (189); 🇺🇸 Phoenix, Arizona, United States

Investigational Site (109); 🇺🇸 San Diego, California, United States

Investigational Site (163); 🇺🇸 Tampa, Florida, United States

Investigational Site (164); 🇺🇸 Las Vegas, Nevada, United States

Investigational Site (162); 🇺🇸 San Antonio, Texas, United States

Investigational Site (127); 🇺🇸 San Antonio, Texas, United States