Cutaneous Lupus Erythematosus (CLE)Phase 2NCT07694336
A Study of Quinacrine in Participants With Cutaneous Lupus Erythematosus
A Phase 2 study testing Quinacrine Hydrochloride in people with Cutaneous Lupus Erythematosus (CLE), run by Victoria Werth at 1 site in United States.
Trial summary
The research study is being conducted to learn more about how patients with cutaneous lupus erythematosus (CLE) respond to the use of quinacrine. Quinacrine is a medication that was originally developed and used starting in the 1930's to treat malaria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- Quinacrine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age at the time of signing the informed consent form.
- Willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and assessments schedule, including the ability to receive or self-administer study treatment at home or outside of the study site clinic.
- Must have diagnosis of SCLE or DLE that has been histologically confirmed (in the past or at Screening), with or without systemic LE manifestations. For participants without historical biopsy data, a skin biopsy must be performed at Screening to confirm CLE diagnosis prior to randomization.
- All participants must also have active skin manifestations that fulfill the following:
- CLASI-A ≥8 at Screening and randomization
- Must have active CLE despite an adequate trial of conventional therapies (defined topical corticosteroids and HCQ used for at least 12 weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12 weeks OR the requirement to discontinue these agents due to side effects or poor tolerability.
- If patients are using HCQ during screening, the same dose should be continued until the end of the study.
Who cannot join
- Have any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
- Have undergone phlebotomy with removal of ≥ 500 mL of blood within 30 days prior to the Screening Visit.
- Have received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to the Screening Visit.
- Have participated in any other study involving an investigational product within the last 30 days or 5 half-lives, whichever is greater, prior to the Screening Visit.
- Subjects receiving treatment with primaquine or any concomitant medication that is a substrate of CYP2D6 at screening or during the study.
- Subjects receiving concomitant medications that are classified as moderate or strong inhibitors of CYP3A4/5 at screening or during the study.
Show all 24Show fewer
- Have any of the following laboratory abnormalities at the Screening Visit (as per the central laboratory)
- Aspartate aminotransferase (AST) ≥ 1.5 x~ upper limit of normal (ULN).
- Alanine aminotransferase (ALT) ≥ 1.5 x~ ULN.
- Total bilirubin ≥ 1.5 ULN. Note: A participant with elevated fasting unconjugated serum bilirubin with documented Gilbert syndrome may be enrolled at the Investigator's discretion.
- Subjects with eGFR < 45 at the time of screening..
- Subjects with G6PD deficiency defined as <30% of normal enzyme activity at the time of screening.
- Have had a cardiovascular event (e.g., acute myocardial infarction, stroke) or revascularization procedure (e.g., percutaneous coronary intervention, coronary artery bypass graft) within 6 months of the Screening Visit.
- Have evidence of prolonged QT (QTcF > 450 msec for males and > 470 msec for females) on electrocardiogram (ECG) at the Screening Visit.
- Have a recent serious infection requiring injectable antimicrobial therapy or hospitalization within the 4 weeks prior to Screening Visit or any ongoing febrile illness or infection requiring oral antimicrobial therapy within 1 week of the Screening Visit.
- Have had any surgical procedure (except for minor procedures) within 4 weeks prior to the Screening Visit.
- Have known active nephritis or neuropsychiatric SLE.
- Have current inflammatory skin disease other than SCLE/DLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- Use of immunosuppressive or disease-modifying treatments for SLE that were initiated less than 3 months prior to Screening, have not been at a stable dose for at least 1 month prior to Screening.
- Have received/used any of the following prior medications or undergone any of the following therapeutic procedures:
- Use of high-potency topical corticosteroid and/or topical agents (immunosuppressant) for skin lesions within 7 days prior to randomization.
- Use of high-potency intralesional corticosteroid within 4 weeks prior to randomization.
- JAK or TYK2 inhibitors within 1 month before the visit 1.
- IFN1/IFN1R inhibitors within 3 months before the Screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, 19104
Victoria P Werth, MD, 215-615-2940, werth@pennmedicine.upenn.edu
Robert Haskins, 215-615-2940, Robert.haskins@pennmedicine.upenn.edu
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Quinacrine (QC) in Participants With Active Cutaneous Lupus Erythematosus (CLE), Including Subacute CLE (SCLE) and/or Discoid LE (DLE), With or Without Concurrent Systemic Manifestations
The research study is being conducted to learn more about how patients with cutaneous lupus erythematosus (CLE) respond to the use of quinacrine. Quinacrine is a medication that was originally developed and used starting in the 1930's to treat malaria. It has been used for decades to help reduce inflammation in the body. Doctors have observed that quinacrine may also help improve skin symptoms in patients with CLE, a condition in which the immune system mistakenly attacks the skin, causing rashes, sores, and other skin problems. Although some doctors have prescribed quinacrine for CLE based on these observations, it has not yet been formally approved by the U.S. Food and Drug Administration (FDA) for this use. The purpose of this clinical trial is to carefully study how safe and effective quinacrine is for treating CLE, as well as how it works in the body. This can help researchers better understand whether it should become a standard treatment option.
Participation will last for about 28 weeks in total. This study is a randomized, double-blind, placebo-controlled study. "Placebo-controlled" means that participants may receive quinacrine or participants may receive a placebo for the first 12 weeks of the study. A placebo looks like the study drug but contains no active medication. It is used to help find out if the results of the study are due to the study drug or due to something else.
Randomized means participants will be put into the study drug group or the placebo group by chance. Participants have a 1:1 chance of receiving the study drug. This means for every 2 people in the study, 1 will receive the study drug and 1 will receive the placebo. Double-blind means that neither participants nor the study team will know which study group participants have been put in. For the next 12 weeks of the study (Week 12-Week 28), all participants will receive the study drug.
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Being tested
- Quinacrine Hydrochloride, Placebo
- Keywords
- Cutaneous Lupus Erythematosus, Quinacrine
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinacrine HydrochlorideDrug
Quinacrine Hydrochloride 100mg Daily
PlaceboOther
Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| Quinacrine (Experimental) | Experimental | Quinacrine 100mg Daily for 12 Weeks Receives: Drug: Quinacrine Hydrochloride |
| Placebo | Placebo comparator | Placebo daily for 12 weeks Receives: Other: Placebo |
| Open Label Extension | Experimental | Quinacrine 100 mg daily for 12 weeks Receives: Drug: Quinacrine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score
Differences in the change in score from baseline to Week 12 between the Quinacrine arm versus placebo arm. Scores range from 0 to 70 with higher scores representing more severe, active disease.
Measured: 12 weeks
Secondary outcomes (6)
Binary responder endpoints based on Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) improvement
- ≥4 point reduction
- ≥50% reduction
- ≥70% reduction
Measured: 24 Weeks
Low Cutaneous Lupus Activity - Investigator's Global Assessment (CLA-IGA) scores
Low activity defined as scores of 0-1 on a scale of 0 (Clear) to 4 (Severe Activity)
Measured: 24 weeks
Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Scores range from 0-100 where lower scores indicate a poorer quality of life
Measured: 24 Weeks
Change From Baseline in Physician Global Assessment (PGA) Score
Scores range from 0 (Clear / no signs of disease) to 5 (Very severe disease activity)
Measured: 24 Weeks
Change From Baseline in Patient Global Assessment (PtGA) Score
Scores range from 0 (Clear / no signs of disease) to 5 (Very severe disease activity)
Measured: 24 Weeks
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank 2.0 - Cognitive Function - Short Form 8a
Standardized measure of cognitive functioning where scores range from 0 - 100. Scores lower than 50 represent impairment, while scores above 50 represent better than average functioning.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start30 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victoria Werth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Victoria Werth, University of Pennsylvania
- Investigators
- Victoria P Werth, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694336
- Sponsor's protocol ID
- AISU0001
- Status last verified
- Aug 2026
- First submitted
- 23 May 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Quinacrine (QC) in Participants With Active Cutaneous Lupus Erythematosus (CLE), Including Subacute CLE (SCLE) and/or Discoid LE (DLE), With or Without Concurrent Systemic Manifestations
- ClinicalTrials.gov ID
- NCT07694336
- Acronym / sponsor ID
- AISU0001
- Conditions
- Cutaneous Lupus Erythematosus (CLE)
- Keywords
- Cutaneous Lupus Erythematosus, Quinacrine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Victoria WerthUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research study is being conducted to learn more about how patients with cutaneous lupus erythematosus (CLE) respond to the use of quinacrine. Quinacrine is a medication that was originally developed and used starting in the 1930's to treat malaria. It has been used for decades to help reduce inflammation in the body. Doctors have observed that quinacrine may also help improve skin symptoms in patients with CLE, a condition in which the immune system mistakenly attacks the skin, causing rashes, sores, and other skin problems. Although some doctors have prescribed quinacrine for CLE based on these observations, it has not yet been formally approved by the U.S. Food and Drug Administration (FDA) for this use. The purpose of this clinical trial is to carefully study how safe and effective quinacrine is for treating CLE, as well as how it works in the body. This can help researchers better understand whether it should become a standard treatment option.
Participation will last for about 28 weeks in total. This study is a randomized, double-blind, placebo-controlled study. "Placebo-controlled" means that participants may receive quinacrine or participants may receive a placebo for the first 12 weeks of the study. A placebo looks like the study drug but contains no active medication. It is used to help find out if the results of the study are due to the study drug or due to something else.
Randomized means participants will be put into the study drug group or the placebo group by chance. Participants have a 1:1 chance of receiving the study drug. This means for every 2 people in the study, 1 will receive the study drug and 1 will receive the placebo. Double-blind means that neither participants nor the study team will know which study group participants have been put in. For the next 12 weeks of the study (Week 12-Week 28), all participants will receive the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quinacrine (Experimental) | Experimental | Drug: Quinacrine HydrochlorideQuinacrine 100mg Daily for 12 Weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo daily for 12 weeks |
| Open Label Extension | Experimental | Drug: Quinacrine HydrochlorideQuinacrine 100 mg daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age at the time of signing the informed consent form.
- Willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and assessments schedule, including the ability to receive or self-administer study treatment at home or outside of the study site clinic.
- Must have diagnosis of SCLE or DLE that has been histologically confirmed (in the past or at Screening), with or without systemic LE manifestations. For participants without historical biopsy data, a skin biopsy must be performed at Screening to confirm CLE diagnosis prior to randomization.
- CLASI-A ≥8 at Screening and randomization
- Must have active CLE despite an adequate trial of conventional therapies (defined topical corticosteroids and HCQ used for at least 12 weeks prior to Screening) OR previously documented failure to respond to these agents when used for at least 12 weeks OR the requirement to discontinue these agents due to side effects or poor tolerability.
Key exclusion criteria (24 listed)
- Have any medical condition or laboratory abnormality during the Screening Period that, in the opinion of the Investigator, is clinically significant and could interfere with the participant's ability to be included in the study.
- Have undergone phlebotomy with removal of ≥ 500 mL of blood within 30 days prior to the Screening Visit.
- Have received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to the Screening Visit.
- Have participated in any other study involving an investigational product within the last 30 days or 5 half-lives, whichever is greater, prior to the Screening Visit.
- Subjects receiving treatment with primaquine or any concomitant medication that is a substrate of CYP2D6 at screening or during the study.
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 |
|---|---|---|
| Quinacrine HydrochlorideQuinacrine Hydrochloride 100mg Daily | Drug | Open Label Extension, Quinacrine (Experimental) |
| PlaceboMatched Placebo | Other | Placebo |
Primary outcome
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score
Time frame: 12 weeks
Differences in the change in score from baseline to Week 12 between the Quinacrine arm versus placebo arm. Scores range from 0 to 70 with higher scores representing more severe, active disease.
6 secondary outcomes
Binary responder endpoints based on Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) improvement
Time frame: 24 Weeks
Low Cutaneous Lupus Activity - Investigator's Global Assessment (CLA-IGA) scores
Time frame: 24 weeks
Change From Baseline in Cutaneous Lupus Erythematosus-Quality of Life (CLE-QoL) Score
Time frame: 24 Weeks
Change From Baseline in Physician Global Assessment (PGA) Score
Time frame: 24 Weeks
Change From Baseline in Patient Global Assessment (PtGA) Score
Time frame: 24 Weeks
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank 2.0 - Cognitive Function - Short Form 8a
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Victoria P Werth, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quinacrine Hydrochloride in people with Cutaneous Lupus Erythematosus (CLE), run by Victoria Werth at 1 site 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 7 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria P Werth, MD (2156152940, penndermautoimmune@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.