Discoid Lupus Erythematosus (DLE)

Researchers are evaluating the use of a non-ablative 1470 nm laser for treating androgenetic alopecia and scarring alopecia in this single-center, open-label pilot study. The study aims to enroll up to 10 participants with biopsy-confirmed alopecia who seek improvement in hair loss. The study includes two treatment groups one for androgenetic alopecia and one for scarring alopecia, with five participants in each. Participants will receive up to three treatments using the Sciton HALO 1470nm non-ablative laser. Each treatment targets affected scalp areas and lasts approximately 10 to 15 minutes. Before treatment, a topical anesthetic and antiseptic cleaning are applied, followed by post-treatment care including topical betamethasone dipropionate cream. Treatments follow a set protocol to create controlled zones in the scalp skin to potentially enhance hair growth. Participants will have follow-up visits at months 6, 9, 12, and 15 after their initial treatment. During these visits, standardized photographs and hair density measurements using the Canfield HairMetrix device will be collected and compared to baseline. Participants will also complete questionnaires regarding pain, satisfaction, and self-assessment of hair growth. The study monitors safety and treatment effects over a total period of approximately 15 months.

Researchers are evaluating VENT-03 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.

Researchers are investigating the effects of enpatoran in adults with active cutaneous lupus erythematosus, with or without systemic lupus erythematosus SLE. This global, multicenter Phase 3 study aims to evaluate the efficacy and safety of enpatoran over a 24-week treatment period, focusing on skin manifestations of lupus. The study is designed as a randomized, double-blind, placebo-controlled trial to assess how well enpatoran works alongside standard care in this population. Participants will receive either enpatoran tablets or placebo tablets twice daily for 24 weeks while continuing their investigator-recommended standard of care. Dosing occurs orally from Day 1 to Day 168. Visits are scheduled every four weeks, except for a televisit at Week 2. The study includes treatment and follow-up visits throughout the treatment period, which lasts up to 35 weeks in total. During the study, participants will undergo regular assessments including evaluation of skin disease severity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index CLASI, and other lupus activity measures. Safety will be monitored by tracking adverse events and laboratory results. Researchers will also assess symptoms such as itch and skin changes. The main outcome is the reduction of skin disease severity at Week 24. Participants may expect scheduled clinic visits and evaluations over the study course until completion in May 2029.

Researchers are studying enpatoran in adults with active skin symptoms of lupus erythematosus, with or without systemic involvement. This global, multicenter Phase 3 trial aims to assess the effectiveness and safety of enpatoran compared to a placebo over 24 weeks. Participants must have certain types of cutaneous lupus, including discoid, subacute, or acute forms, and may also have systemic lupus erythematosus SLE. The study is sponsored by EMD Serono Research & Development Institute, Inc.

Researchers are studying how patients with cutaneous lupus erythematosus CLE respond to quinacrine, a medication originally used to treat malaria that might help improve skin symptoms in CLE. This randomized, double-blind, placebo-controlled trial aims to carefully evaluate the safety, effectiveness, and how quinacrine works in the body to better understand if it could become a standard treatment for CLE. Participants will be randomly assigned to receive either quinacrine 100 mg daily or a placebo for the first 12 weeks, with a 11 chance of being in either group. After this period, all participants will receive quinacrine for an additional 16 weeks, making the total treatment duration 28 weeks. The placebo looks like the study drug but contains no active medication, and neither participants nor the study team will know group assignments during the first 12 weeks. Throughout the study, participants will be assessed for changes in their skin condition using the Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity CLASI-A score at 12 weeks and other skin-related and quality of life measures up to 24 weeks. Safety, effectiveness, and patient-reported outcomes will be monitored during regular visits. Participation lasts about 28 weeks in total.

Researchers are evaluating how mosunetuzumab works in people with systemic lupus erythematosus SLE, including those who may have active lupus nephritis LN. This Phase II open-label study aims to assess the drugs effects on disease remission and kidney response in this population. Hoffmann-La Roche sponsors the study to understand efficacy, safety, and pharmacokinetics of mosunetuzumab in these patients. Participants will receive mosunetuzumab through subcutaneous SC injections. The study is a single-group design where all participants receive the investigational drug. Treatment and observation will continue up to 2.5 years, with key outcome assessments scheduled up to Week 76 and beyond for kidney response and safety monitoring. During the trial, participants will undergo various assessments including disease activity evaluations, kidney response measurements, blood tests for immune markers, and monitoring for adverse events. Researchers will track remission status, renal outcomes, drug levels, and immune responses. The total study duration extends up to about 2.5 years, including long-term safety follow-up and evaluation of fatigue and disease activity changes.

Researchers are studying the use of the AVAVA Device, a 1550nm Non-Ablative Fractional Laser, to treat various dermatologic conditions including acne, acne scars, wrinkles, pigment lesions, and skin texture disorders. The study aims to collect and analyze patient feedback on their overall experience with the device treatment. The primary focus is on responses to post-treatment questionnaires, while secondary measures include evaluations by physicians and patients regarding improvements and side effects. Participants will receive treatment using the AVAVA Device targeting their dermatologic condition. The study includes follow-up periods at 3, 6, and 12 months after the final treatment to assess outcomes. During these times, trained dermatologists will review before and after images, and both physicians and subjects will complete satisfaction and clinical improvement scales. The treatment process involves digital photography and adherence to specific skincare and sun exposure guidelines. Throughout the study, participants will complete questionnaires immediately after treatment and during follow-up visits to report their experience and tolerance of the procedure, including pain levels. Researchers will monitor the skins response and improvements over time through imaging and clinical assessments. The study requires participants to comply with study instructions, maintain consistent skincare, and attend scheduled visits. The total participation duration spans from initial treatment through 12 months of follow-up.

Researchers are studying the use of CART19, a CD19-directed chimeric antigen receptor T cell therapy, in children and young adults aged 12 to 29 years with refractory systemic lupus erythematosus SLE. This includes patients diagnosed with lupus nephritis and those with non-renal SLE. The study is a single-center, single-arm, open-label phase 12 trial aiming to evaluate the safety and effectiveness of CART19 cells in this population, building on previous limited clinical experience with this approach. Participants will receive an intravenous infusion of CART19 cells that have been genetically modified using a lentiviral vector to express anti-CD19 components. Phase 1 focuses on safety, with 6 to 12 patients enrolled and dose de-escalation possible based on dose-limiting toxicities. Phase 2 will then assess the therapys efficacy and continue safety evaluations. The treatment aims to deeply reduce the B cell compartment involved in SLE. During the study, participants will be monitored for up to 24 months after infusion to assess dose-limiting toxicities and other outcomes such as clinical remission off steroids, survival rates, renal response, cell persistence, and cytokine levels. Researchers will evaluate the feasibility of manufacturing CART19 cells and monitor participants health through clinical assessments and laboratory tests. The total duration of participation may extend up to two years post-treatment to capture long-term data and safety.

Researchers are evaluating the safety and tolerability of SOF-SKN cream applied topically in healthy volunteers aged 18 to 64 years. The study is designed in two parts Part 1 uses a single ascending dose SAD approach, and Part 2 uses a multiple ascending dose MAD approach. This phase I clinical trial aims to monitor how the body reacts to different concentrations of the cream and to assess pharmacokinetics. The study includes four dose levels 0.25%, 0.5%, 1%, and 2% applied as 2 g of SOF-SKN cream to a 10 x 30 cm area on either side of the participants back. Part 1 participants receive a single application, while Part 2 participants apply the cream daily for 14 days. Each participant also receives a placebo cream on the opposite side of the back to serve as a control. Safety monitoring will be conducted throughout the dose escalation. Participants will undergo a 28-day screening before dosing. After treatment, safety assessments will be made by tracking target toxicities, adverse events, and serious adverse events over days following the last application. Pharmacokinetic measurements will be taken at multiple timepoints up to 24 hours after a single dose and up to 17 days for multiple doses. The study will enroll up to 32 participants, with up to 16 in each part, and will follow them closely to monitor safety and how the drug behaves in the body.

Researchers are collecting biological and clinical data from patients with systemic autoimmune diseases to better understand these complex conditions. These diseases affect a notable portion of adults, mostly women, and involve the immune system attacking the body. The study aims to identify new biomarkers and improve diagnosis and treatment options by exploring the clinical, biological, and genetic differences among patient groups. Participants will provide blood samples during their routine diagnosis and follow-up visits, with a larger amount of blood taken specifically for this study. This observational study focuses on patients with rare systemic autoimmune diseases or atypical forms who may be undergoing innovative treatments such as new drugs, gene therapy, or cell therapy. During the study, researchers will collect biological samples and clinical data and analyze them to find new diagnostic and prognostic markers, predict relapses or treatment responses, and understand disease mechanisms. The study will monitor patients for about one year, with the goal of improving personalized medicine approaches for these autoimmune diseases.