Phase 4 Lupus Trial, Recruiting NCT05559671 Sponsor: NYU Langone Health Condition: Lupus
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Phase 4 Lupus Trial, Recruiting

NCT05559671
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing and able to give informed consent before any study procedures begin
  • People who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with Systemic Lupus Erythematosus (SLE/Lupus) based on a specific set of internationally recognised classification criteria from 2019
  • Female participants must use at least one reliable method of birth control throughout the study, unless they have had their ovaries or uterus surgically removed, have a partner who has had a vasectomy, have been through menopause for at least one year (confirmed by a specific hormone blood test), or do not have sex as a consistent part of their lifestyle

Who may not be able to join:

  • People who have previously received either of the two shingles vaccines (Shingrix or Zostavax)
  • People who have had a shingles infection in the 12 months before or during the screening period
  • People whose lupus disease activity score is above a certain level at the time of screening (confirm with trial site)
  • People who are experiencing a lupus flare at the time of screening
  • People whose lupus symptoms have worsened between the screening visit and the enrolment visit
  • People who have received any vaccine, including a COVID-19 vaccine dose, within six weeks before enrolment
  • People who have received certain strong immune-suppressing medications (rituximab or cyclophosphamide) within nine months before enrolment
  • People who have taken part in another clinical trial for lupus or other treatments within six months before enrolment
  • People who have had a moderate to severe fever-causing infection, or who have taken antibiotic, antiviral, antifungal, or antiparasitic medicines within four weeks before enrolment
  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the study
  • People who have a known condition that significantly weakens the immune system, such as HIV, certain immune deficiency disorders, or active cancer, or who are currently receiving chemotherapy

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Amit Saxena, MD, NYU Langone Health

Phone: 646-501-7384

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
21 December 2023
Est. completion
31 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov