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ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
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

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
GroupInterventionDescription
ALPN-101 (acazicolcept)ALPN-101-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Adverse EventsFrom study Day 1 until End of Study (28 weeks)

Type, incidence, and severity of adverse events as assessed by CTCAE

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (46)

Investigational Site (107)

🇺🇸

Anniston, Alabama, United States

Investigational Site (189)

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Phoenix, Arizona, United States

Investigational Site (155)

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Los Angeles, California, United States

Investigational Site (109)

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San Diego, California, United States

Investigational Site (169)

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Santa Barbara, California, United States

Investigational Site (106)

🇺🇸

DeBary, Florida, United States

Investigational Site (120)

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Hialeah, Florida, United States

Investigational Sites (134)

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Miami, Florida, United States

Investigational Site (152)

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Ormond Beach, Florida, United States

Investigational Site (133)

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Plantation, Florida, United States

Scroll for more (36 remaining)
Investigational Site (107)
🇺🇸Anniston, Alabama, United States

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