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Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

NCT04058028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2024-09-24

Study results available
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Summary

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

Conditions

  • Systemic Lupus Erythematosus (SLE)

Interventions

DRUG

Rozibafusp Alfa

Rozibafusp Alfa will be presented in 5 mL glass vial

DRUG

Placebo for Rozibafusp Alfa

Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2023-07-25
Completion
2023-07-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

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 NCT04058028 on ClinicalTrials.gov