NCT05799378

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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 =60 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 2 months for one year to assess disease activity and flares.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Hydroxychloroquine 200mg capsules. Administered orally.
DRUG	Placebo	Hydroxychloroquine-matching placebo capsule. Administered orally.

Timeline

• Start date: 2024-06-27
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2023-04-05
• Last updated: 2026-02-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study