Phase 2 N=187 Randomized Quadruple-blind Prevention

Study of Anti-Malarials in Incomplete Lupus Erythematosus

Systemic Lupus Erythematosus

Bottom Line

View on ClinicalTrials.gov: NCT03030118 ↗

Enrolled (actual)

187

Serious AEs

5.0%

Results posted

Aug 2025

Primary outcome: Primary: SLICC Score — 62; 56; 46; 41 participants — p=0.72

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hydroxychloroquine (Drug); Placebo Oral Capsule (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY SLICC Score	62; 56; 46; 41; 35; 40	0.72
SECONDARY Number of Subjects With Disease Progression	12; 12	0.81
SECONDARY Number of Subjects Meeting Disease Activity Scores Defined Below	43; 45; 44; 37; 36; 45	0.74
SECONDARY Count of Participants With Defined Disease Activity	0; 0; 67; 66; 9; 10	0.77
SECONDARY Patient Reported Outcome Physical Function	48.5; 48.9; 49.6; 49.7; 49.5; 49.4	0.386
SECONDARY Patient Reported Outcomes Fatigue	54.7; 55.0; 53.0; 53.1; 52.2; 53.2	0.497
SECONDARY Physician Global Asssessment	1; 1; 39; 40; 35; 31	0.99
SECONDARY Fluorescence Intensity (FI) of Autoantibodies in Serum	1319; 1243; 5461; 5454; 2838; 2582	>0.05
SECONDARY Ophthalmologic Toxicity as Measured by Snellen Visual Acuity	6; 7; 0; 0; 4; 6	>0.5
SECONDARY Ophthalmologic Toxicity by Humphrey Visual Field Testing	0; 0	1.00
SECONDARY Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.	0; 0	1.00

Summary

This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. This trial is a first step in testing a prevention strategy for lupus.

Eligibility Criteria

Inclusion Criteria

Between 15 and 49 years of age, inclusive, at Visit 1.
Anti-nuclear antibody (ANA) titer of 1: 80, or greater, as determined by immunofluorescence assay (IFA).
Participants must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria

The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e., ANA plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis).
The subject has been diagnosed with another autoimmune disorder, other than autoimmune thyroid conditions.
The subject has fibromyalgia, based on clinical history and exam.
The subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine, or quinacrine.
The subject is currently or has been treated with immunosuppressive, immune modifying, or cytotoxic medications as listed in Section 7.2.
Use of any investigational agent within the preceding 12 months.
History of primary immunodeficiency.
Active bacterial, viral, fungal, or opportunistic infection.
Evidence of infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
Concomitant malignancy or history of malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
The subject has significant findings on ophthalmological examination that, in the opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine.
The subject has other contraindications to treatment with hydroxychloroquine including pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to the drug or class.
Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1.
Starting, stopping, or changing the dose of over the counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1.
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Inability to comply with the study visit schedule and procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03030118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.