ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Drug: ALPN-101Drug: 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
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
- Secondary Outcome Measures
Name Time Method
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)
ðŸ‡ðŸ‡ºSzékesfehérvár, Hungary
Investigational Site (128)
🇫🇷Paris, France
Investigational Site (180)
ðŸ‡ðŸ‡ºGyula, 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)
ðŸ‡ðŸ‡ºBudapest, 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