At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
Efavaleukin Alfa +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of Efavaleukin Alfa in Subjects With Systemic Lupus Erythematosus
In Brief
A Phase 1 clinical trial evaluating Efavaleukin Alfa and Placebo for Systemic Lupus Erythematosus. Completed, enrolled 35 participants across 15 sites in 4 countries.
Detailed Summary
To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin Alfa in participants with systemic lupus erythematosus (SLE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesFrance, Germany, Poland, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartApr 2018
Primary CompletionOct 2021
TodayJul 2026
First PostedMar 1, 2018
Enrollment StartApr 10, 2018
Primary CompletionOct 12, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.3 years ago
Interventions
Efavaleukin Alfadrug
Efavaleukin Alfa will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.
Placebodrug
The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm.