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Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

NCT04925934 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-07-23

Study results available
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Summary

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

VIB7734

VIB7734

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

  • Nisha Jain, MD · Horizon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2023-05-16
Completion
2023-06-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Greece
  • India
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Spain
  • Taiwan
  • Ukraine

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 NCT04925934 on ClinicalTrials.gov