This clinical trial is focused on studying a condition called Cutaneous Lupus Erythematosus, which affects the skin. The study will evaluate a treatment called Anifrolumab, which is given as a solution for injection. Anifrolumab is being compared to a placebo to see how effective it is in treating skin symptoms in adults who have not responded well to or cannot tolerate antimalarial therapy.
The purpose of the study is to assess the effectiveness and safety of Anifrolumab in improving skin conditions associated with Cutaneous Lupus Erythematosus. Participants will receive either Anifrolumab or a placebo through a subcutaneous injection, which means the injection is given under the skin. The study will be conducted in two stages, with the main focus on observing changes in skin symptoms at Week 24. The study will last up to 52 weeks, allowing researchers to monitor the long-term effects of the treatment.
Throughout the study, participants will be closely monitored for any changes in their skin condition and any side effects they may experience. The study aims to provide valuable information on whether Anifrolumab can be a beneficial treatment option for those with Cutaneous Lupus Erythematosus who have limited options due to their intolerance or inadequate response to existing therapies.
1Joining the study
Upon joining the study, the participant will be randomly assigned to receive either anifrolumab or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
2Initial treatment phase
The participant will receive a subcutaneous injection of either anifrolumab or a placebo. The injection is a solution administered under the skin.
The dosage and frequency of the injections will be determined by the study protocol, and the participant will be informed of the schedule.
3Monitoring and assessments
Throughout the study, the participant’s skin condition will be regularly assessed to evaluate the effectiveness of the treatment. This includes measuring changes in skin manifestations associated with cutaneous lupus erythematosus.
Assessments will occur at specified intervals, including at Week 12 and Week 24, to monitor progress and any potential side effects.
4Stage 1 evaluation
At Week 24, the primary goal is to assess the response of the skin condition to the treatment. This includes evaluating the CLA-IGA-R erythema response and the CLASI-70 response.
Secondary assessments will also be conducted to measure other skin-related outcomes and overall health.
5Stage 2 continuation
If the participant continues to the second stage, further assessments will be conducted to demonstrate the superiority of anifrolumab over the placebo.
The participant will continue receiving the assigned treatment and undergo regular evaluations up to Week 52.
6Final assessments and study completion
The study will conclude with final assessments to determine the long-term effects and safety of the treatment.
The participant’s overall experience, including any adverse events, will be documented to contribute to the study’s findings.
Who Can Join the Study?
Participants must be between 18 and 70 years old at the time of signing the consent form.
Participants must have a confirmed diagnosis of Cutaneous Lupus Erythematosus (CLE), which is a skin condition. This diagnosis should be confirmed both clinically (by a doctor) and histologically (by examining tissue under a microscope).
Participants must have a CLASI-A total score of 10 or more at the start and confirmed at randomization. This is a score used to measure the severity of skin symptoms in CLE.
Participants must have a CLA-IGA-R erythema score of 3 or more and a CLA-IGA-R OMC score of 1 or more at the start and confirmed at randomization. These scores are used to assess the redness and other skin changes in CLE.
Participants must have had an inadequate response or intolerance to antimalarial therapy. This means they either did not respond well to or could not tolerate medications usually used to treat CLE.
If antimalarial treatment was not started due to medical reasons, participants must have tried at least one of the following treatments for CLE before the start:
Topical calcineurin inhibitors for 3 months or more. These are creams or ointments used to reduce inflammation.
Systemic glucocorticoids for 6 weeks or more. These are steroid medications taken by mouth or injection to reduce inflammation.
A conventional immunosuppressant like azathioprine, mycophenolate mofetil, retinoids, dapsone, or methotrexate for 3 months or more. These are medications that help control the immune system.
Participants should have no history or signs of active or past tuberculosis (TB) infection. TB is a bacterial infection that mainly affects the lungs.
Participants must have a negative result on a TB test called an IFN-γ release assay (e.g., QFT-G test).
Participants must follow local guidelines for contraceptive use during the study.
Females who are or have been sexually active must have a normal cervical cancer screening result (like a Pap smear or HPV test) within 2 years before the study starts.
Participants must have a negative COVID-19 test result at the start and should not have had known or suspected exposure to COVID-19 within 2 weeks before the start. If exposed, they must test negative 2 weeks after exposure and have no symptoms to join the study.
Who Cannot Join the Study?
Patients with other serious skin conditions that could interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received certain medications that might affect the study results.
Patients with a history of severe allergic reactions to medications.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients with certain chronic diseases that are not well controlled.
Patients who have participated in another clinical trial recently.
Patients who have had a recent vaccination.
Patients with a history of cancer, except for some types of skin cancer.
Patients with a weakened immune system.
Patients who are unable to comply with the study procedures.
Anifrolumab is a medication being studied for its effectiveness in treating skin symptoms in adults with chronic and/or subacute cutaneous lupus erythematosus (CLE). This condition involves persistent skin rashes and lesions. Anifrolumab is being tested to see if it can help improve these skin issues in patients who have not responded well to or cannot tolerate standard antimalarial treatments. The trial aims to determine if anifrolumab is better than a placebo in reducing skin problems associated with CLE.
Cutaneous Lupus Erythematosus – This is a chronic autoimmune disease that primarily affects the skin, leading to inflammation and distinctive skin lesions. The disease can manifest in various forms, including discoid lupus erythematosus, which causes round, red, and scaly patches. These lesions often appear on sun-exposed areas such as the face, neck, and scalp. Over time, the lesions may lead to scarring and changes in skin pigmentation. The condition can fluctuate, with periods of flare-ups and remission. Environmental factors, such as sun exposure, can exacerbate the symptoms.
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