Systemic Lupus ErythematosusPhase 2SMILENCT03030118
Study of Anti-Malarials in Incomplete Lupus Erythematosus
A Phase 2 study testing Hydroxychloroquine in people with Systemic Lupus Erythematosus, run by Milton S. Hershey Medical Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Dec 2017to 30 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Medical University of South Carolina
Charleston, South Carolina, 29425
UT Southwestern Medical Center
Dallas, Texas, 75390
Northwell Health
Great Neck, New York, 11021
Penn State MS Hershey Medical Center
Hershey, Pennsylvania, 17033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the detailed description
Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidenced-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE). We propose to treat ILE patients with hydroxychloroquine (HCQ) in the "Study of Anti-Malarials in Incomplete Lupus Erythematosus" or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE.
The major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus disease activity as measured by standard scoring indices; (2) improves patient reported outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are:
- To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ can modify disease features so that accumulation of abnormalities leading to a classification of SLE can be significantly slowed.
- To determine effects of HCQ on disease activity and patient-reported outcomes in patients with ILE.
- To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies, cytokines and chemokines will be measured on multiplex arrays for developing insights into underlying mechanisms.
- To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE patients. All enrolled patients will have standardized ophthalmologic examinations before and after study treatment. Recommendations for use and monitoring in this patient population will be developed.
The SMILE trial will determine whether or not HCQ should be given to ILE patients, will provide insights into the appropriate target population, and will propose candidate biomarkers to guide treatment decisions. While not part of the Precision Medicine Initiative®, SMILE is consistent with its goals. It will be the first step towards testing the feasibility of disease prevention studies in SLE and will accumulate biological samples in a repository that will be available to the lupus research community for further in-depth mechanistic studies.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Hydroxychloroquine, Placebo Oral Capsule
- Keywords
- hydroxychloroquine
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
Placebo Oral CapsuleDrug
Also called Placebo
An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Active comparator | Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks. Receives: Drug: Hydroxychloroquine |
| Placebo oral capsule | Placebo comparator | Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks. Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLICC Score
The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.
Measured: Measured every 12 weeks for 96 weeks.
Secondary outcomes (10)
Number of Subjects With Disease Progression
The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.
Measured: Measured up to 96 weeks.
Number of Subjects Meeting Disease Activity Scores Defined Below
Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease
Measured: Measured every 12 weeks for 96 weeks.
Count of Participants With Defined Disease Activity
Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity
Measured: Measured every 12 weeks for 96 weeks
Patient Reported Outcome Physical Function
The PROMIS 29 Adult Profile: Physical Function T Scores The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.
Higher score indicates better physical function
Measured: Measured every 12 weeks for 96 weeks
Patient Reported Outcomes Fatigue
Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items T Scores are reported. The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.
Higher scores indicate more fatigue
Measured: Measured every 12 weeks for up to 96 weeks
Physician Global Asssessment
Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status
Measured: Measured every 12 weeks for up to 96 weeks
Fluorescence Intensity (FI) of Autoantibodies in Serum
Fluorescence intensity of Autoantibodies will be measured using a slide array. Minimum score is 0.1 Maximum score >100 A higher score indicates higher level of the autoantibody being measured.
Measured: Measured at baseline and final visit up to 96 weeks.
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Snellen visual acuity measured in right and left eyes Scale 10 to 50 with higher numbers indicating lower visual acuity Number of participants with each level of visual acuity in right eye and left eye are counted in the two groups at the final visit
Measured: Measured at up to 96 weeks or final visit
Ophthalmologic Toxicity by Humphrey Visual Field Testing
Number of participants with abnormal visual field testing at the final visit.
Measured: Measured at final visit up to 96 weeks
Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.
Number of participants with abnormal spectral domain ocular coherence tomography at final visit
Measured: Measured at up to 96 weeks or final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start28 Dec 2017
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Nancy Olsen, Milton S. Hershey Medical Center
- Investigators
- Nancy J Olsen, MD, Principal investigator, Penn State MS Hershey Medical CenterDavid R Karp, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030118
- Sponsor's protocol ID
- STUDY00003506
- Other IDs
- U01AR071077
- Acronym
- SMILE
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2017
- Last updated
- 16 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators upon reasonable request. This will include all patient-level measurements and instruments, as well as the laboratory results.
Publications
Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802.
PubMed 30369087Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7.
PubMed 30572906Olsen NJ, Liao D, James JA, Guthridge JM, Arriens C, Kamen D, Ishimori M, Wallace DJ, Striebich C, Narain S, Chong BF, He F, Schaefer EW, Chinchilli VM, Karp DR. A Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Incomplete Lupus. Arthritis Rheumatol. 2026 Apr;78(4):870-879. doi: 10.1002/art.43391. Epub 2025 Dec 12.
PubMed 40955637Porta SV, Ugarte-Gil MF, Garcia-de la Torre I, Bonfa E, Gomez-Puerta JA, Arnaud L, Cardiel MH, Alarcon GS, Pons-Estel BA, Pons-Estel G. Controversies in Systemic Lupus Erythematosus: Are We Treating Our Patients Adequately? J Clin Rheumatol. 2022 Mar 1;28(2):e651-e658. doi: 10.1097/RHU.0000000000001803.
PubMed 34897194
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-Malarials in Incomplete Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03030118
- Acronym / sponsor ID
- SMILE / STUDY00003506
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- hydroxychloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidenced-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE). We propose to treat ILE patients with hydroxychloroquine (HCQ) in the "Study of Anti-Malarials in Incomplete Lupus Erythematosus" or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE.
The major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus disease activity as measured by standard scoring indices; (2) improves patient reported outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are:
- To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ can modify disease features so that accumulation of abnormalities leading to a classification of SLE can be significantly slowed.
- To determine effects of HCQ on disease activity and patient-reported outcomes in patients with ILE.
- To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies, cytokines and chemokines will be measured on multiplex arrays for developing insights into underlying mechanisms.
- To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE patients. All enrolled patients will have standardized ophthalmologic examinations before and after study treatment. Recommendations for use and monitoring in this patient population will be developed.
The SMILE trial will determine whether or not HCQ should be given to ILE patients, will provide insights into the appropriate target population, and will propose candidate biomarkers to guide treatment decisions. While not part of the Precision Medicine Initiative®, SMILE is consistent with its goals. It will be the first step towards testing the feasibility of disease prevention studies in SLE and will accumulate biological samples in a repository that will be available to the lupus research community for further in-depth mechanistic studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Active comparator | Drug: HydroxychloroquineHydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks. |
| Placebo oral capsule | Placebo comparator | Drug: Placebo Oral CapsulePlacebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilHydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis. | Drug | Hydroxychloroquine |
| Placebo Oral CapsuleAlso: PlaceboAn oral capsule placebo is made to match the active intervention medication hydroxychloroquine. | Drug | Placebo oral capsule |
Primary outcome
SLICC Score
Time frame: Measured every 12 weeks for 96 weeks.
The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.
10 secondary outcomes
Number of Subjects With Disease Progression
Time frame: Measured up to 96 weeks.
Number of Subjects Meeting Disease Activity Scores Defined Below
Time frame: Measured every 12 weeks for 96 weeks.
Count of Participants With Defined Disease Activity
Time frame: Measured every 12 weeks for 96 weeks
Patient Reported Outcome Physical Function
Time frame: Measured every 12 weeks for 96 weeks
Patient Reported Outcomes Fatigue
Time frame: Measured every 12 weeks for up to 96 weeks
Physician Global Asssessment
Time frame: Measured every 12 weeks for up to 96 weeks
Fluorescence Intensity (FI) of Autoantibodies in Serum
Time frame: Measured at baseline and final visit up to 96 weeks.
Ophthalmologic Toxicity as Measured by Snellen Visual Acuity
Time frame: Measured at up to 96 weeks or final visit
Ophthalmologic Toxicity by Humphrey Visual Field Testing
Time frame: Measured at final visit up to 96 weeks
Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.
Time frame: Measured at up to 96 weeks or final visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30369087Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802.
- Background: PubMed 30572906Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7.
- Derived from this study: PubMed 40955637Olsen NJ, Liao D, James JA, Guthridge JM, Arriens C, Kamen D, Ishimori M, Wallace DJ, Striebich C, Narain S, Chong BF, He F, Schaefer EW, Chinchilli VM, Karp DR. A Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Incomplete Lupus. Arthritis Rheumatol. 2026 Apr;78(4):870-879. doi: 10.1002/art.43391. Epub 2025 Dec 12.
- Derived from this study: PubMed 34897194Porta SV, Ugarte-Gil MF, Garcia-de la Torre I, Bonfa E, Gomez-Puerta JA, Arnaud L, Cardiel MH, Alarcon GS, Pons-Estel BA, Pons-Estel G. Controversies in Systemic Lupus Erythematosus: Are We Treating Our Patients Adequately? J Clin Rheumatol. 2022 Mar 1;28(2):e651-e658. doi: 10.1097/RHU.0000000000001803.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators upon reasonable request. This will include all patient-level measurements and instruments, as well as the laboratory results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy J Olsen, MD principal investigator
Penn State MS Hershey Medical Center
David R Karp, MD PhD principal investigator
University of Texas Southwestern Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine in people with Systemic Lupus Erythematosus, run by Milton S. Hershey Medical Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLICC Score (time frame: Measured every 12 weeks for 96 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030118, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.