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Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

NCT05430854 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2024-09-19

Study results available
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Summary

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Conditions

Interventions

BIOLOGICAL

Daxdilimab

Daxdilimab will be administered subcutaneously as two injections for each dose.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases
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 NCT05430854 on ClinicalTrials.gov