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Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

NCT04680637 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2024-06-28

Study results available
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Summary

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

Conditions

  • Active Systemic Lupus Erythematosus

Interventions

DRUG

Efavaleukin Alfa

Administered as a subcutaneous (SC) injection.

DRUG

Placebo

Administered as a subcutaneous (SC) injection.

OTHER

Standard of Care

Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2023-05-22
Completion
2023-05-22
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • France
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680637 on ClinicalTrials.gov