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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
1,370 Previous Clinical Trials
1,377,533 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
913 Previous Clinical Trials
923,976 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enlist in this research initiative?

"This medical trial is currently sourcing 156 patients with lupus erythematosus, systemic between the ages of eighteen and seventy-two. To qualify for consideration, individuals must be able to comprehend and sign a written informed consent form, have completed the RECAST SLE study period, women of childbearing potential must provide a negative urine pregnancy test on Day 1., Nonsterilized male participants in sexual relations with female partners that are also capable of reproducing must agree to use condoms treated with spermicide from Day 1 until 3 months after receiving their last dose."

Answered by AI

How many healthcare facilities are conducting this clinical trial within the state?

"16 sites are currently enrolling patients. These include Millennium Research in Ormond Beach, Clinical Research of West Florida Inc - Tampa in Tampa and DJL Clinical Research in Charlotte amongst other locales."

Answered by AI

What prospective risks does Daxdilimab pose to individuals?

"Based on our team's evaluation, Daxdilimab was assigned a safety rating of 2 due to the lack of clinical evidence in support of its efficacy. That said, there are some data points that suggest it is safe for use."

Answered by AI

Does this research endeavor restrict participants to those over 75 years of age?

"All individuals 18 years or older, and yet to reach the age of 72 are eligible for enrollment in this research."

Answered by AI

Are there currently any opportunities for volunteers to join the trial?

"The details hosted on clinicaltrials.gov declare that this clinical trial is not accepting patients at the moment, despite being initially posted on June 1st 2022 and last edited later in the month. Nevertheless, 122 other medical studies are presently seeking participants."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Emory University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
2022. "Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05430854.
~55 spots leftby Apr 2025
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