Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

ClinicalTrials.gov ID: NCT05799378

Public ClinicalTrials.gov record NCT05799378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 4, 2026, 12:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients \>=55 years old. The central hypothesis is that HCQ can be safely discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 3 months for one year to assess disease activity and flares.

Study identification

NCT ID: NCT05799378
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: NYU Langone Health; Other
Enrollment: 330 participants

Conditions and interventions

Conditions

Systemic Lupus Erythematosus

Interventions

Hydroxychloroquine Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 55 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 26, 2024
Primary completion: Dec 30, 2028
Completion: Jun 29, 2029
Last update posted: Aug 19, 2026

2024 – 2029

United States locations

U.S. sites: 12
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
University of California, Los Angeles	Los Angeles	California	90095	Recruiting
University of California: San Diego	San Diego	California	92093	Recruiting
Emory University School of Medicine	Atlanta	Georgia	30322	Recruiting
Hackensack Meridian Health	Hackensack	New Jersey	07601	Recruiting
VA NY Harbor Healthcare System	New York	New York	10010	Recruiting
NYC Health + Hospitals/Bellevue	New York	New York	10016	Recruiting
NYU Langone Health	New York	New York	10016	Recruiting
Hospital for Special Surgery	New York	New York	10021	Recruiting
Columbia University Irving Medical Center/New York Presbyterian	New York	New York	10032	Recruiting
Montefiore Medical Center/Albert Einstein College of Medicine	The Bronx	New York	10461	Completed
Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	73104	Recruiting
Penn State MS Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05799378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2026 · Synced Sep 4, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05799378 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →