Recruiting
Phase 3

Hydroxychloroquine

Sponsor:

NYU Langone Health

Code:

NCT05799378

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Hydroxychloroquine

Placebo

Study Details

Brief summary:

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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT05799378

Start date

Jun 27, 2024

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age ≥ 55 years at time of enrollment
  • Normal OCT and VF assessment within 6 months of screening visit
  • Ability to take oral medication
  • Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)
  • Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.

  • Criterion 1: Clinical SLEDAI= 0
  • Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is no disease activity and 3 is maximum disease activity)
  • Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily
  • No moderate or severe flares one year prior to screening
  • Taking ≥ 200 HCQ daily for ≥ 7 years

Exclusion Criteria:

  • Any patient that does not attain stable disease status by DORIS
  • Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)
  • Clinical SLEDAI > 0
  • Taking > 5 mg/day prednisone
  • Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)
  • Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI
  • HCQ level < 100 ng/ml as this would support noncompliance and less reliance on HCQ to control activity
  • Patient unwilling or unable to comply with study procedures for any reason
  • Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydroxychloroquine (HCQ)

Patients will receive a 90-day supply of HCQ at their screening visit and at 3 months, 6 months, 9 months and 12 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ dose administered will match each patient's dosage of HCQ at enrollment.

placebo comparator: HCQ-Matching Placebo

Patients will receive a 90-day supply of HCQ-matching placebo at their screening visit and at 3 months, 6 months, 9 months and 12 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ-matching placebo dose administered will match each patient's dosage of HCQ at enrollment.

Interventions

Hydroxychloroquine

Hydroxychloroquine 200mg capsules. Administered orally.

Placebo

Hydroxychloroquine-matching placebo capsule. Administered orally.

Primary outcome measure

  • Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI) [ Time Frame: Up to Month 12 ]

Central Contacts and Locations

Central contacts

Mala Masson

(212) 263-0372Mala.Masson@nyulangone.org

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

University of California: San Diego

Recruiting

San Diego, California, United States, 92093

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Hackensack Meridian Health

Recruiting

Hackensack, New Jersey, United States, 07601

VA NY Harbor Healthcare System

Recruiting

New York, New York, United States, 10010

NYC Health + Hospitals/Bellevue

Recruiting

New York, New York, United States, 10016

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Columbia University Irving Medical Center/New York Presbyterian

Recruiting

New York, New York, United States, 10032

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Penn State MS Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Hydroxychloroquine
  • systemic lupus erythematosus
  • elderly lupus disease
  • lupus
  • sle
  • plaquenil

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-20.