Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efavaleukin Alfa in Participants With Systemic Lupus Erythematosus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 132
Summary
- Conditions
- Systemic Lupus Erythematosus
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This phase 1b study is a double-blind, placebo controlled multiple ascending dose (MAD) study to evaluate the safety and tolerability of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE) and to determine the recommended phase 2 dose(s). Participants will be treated for a total of 12 weeks followed by a 6 week follow-up period. Five dosing cohorts are planned for the study.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03451422
- Collaborators
- Not Provided
- Investigators
- Study Director: MD Amgen
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