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Monoclonal Antibodies

Daxdilimab for Lupus (RECAST SLE OLE Trial)

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 48
Awards & highlights

RECAST SLE OLE Trial Summary

This trial tests the long-term safety and tolerability of a drug for people with lupus.

Who is the study for?
This trial is for individuals who have completed the RECAST SLE study for Systemic Lupus Erythematosus. Participants must be able to consent, use contraception if of childbearing potential, and not have any health changes that could affect the trial's safety or results.Check my eligibility
What is being tested?
The study tests Daxdilimab's long-term safety and effectiveness in treating Systemic Lupus Erythematosus. It's an open-label extension, meaning all participants know they're receiving Daxdilimab after finishing the initial RECAST SLE study.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include immune system reactions, infections due to lowered immunity, infusion-related reactions, and possible impacts on liver function.

RECAST SLE OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).
Secondary outcome measures
Anti-drug antibody (ADA) rate.
Body Weight Changes

RECAST SLE OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: DaxdilimabExperimental Treatment1 Intervention
Daxdilimab injections over a total of 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daxdilimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,528 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,321 Total Patients Enrolled
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,575 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus

Media Library

Daxdilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05430854 — Phase 2
Lupus Research Study Groups: Daxdilimab
Lupus Clinical Trial 2023: Daxdilimab Highlights & Side Effects. Trial Name: NCT05430854 — Phase 2
Daxdilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430854 — Phase 2
~52 spots leftby Jun 2025
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