Discoid Lupus Erythematosus (DLE)

Researchers are evaluating the use of a non-ablative 1470 nm laser to treat androgenetic alopecia and scarring alopecia in adults. This pilot study is open-label, baseline-controlled, and conducted at a single center. The study includes participants with biopsy-proven alopecia who have experienced stable hair loss for at least six months. The goal is to explore the laser's effects on hair loss improvement, as it has not yet been tested for these conditions despite FDA clearance for dermatologic use. Participants will be divided into two groups, each with five people: one group for androgenetic alopecia and one for scarring alopecia. Each subject may receive up to three laser treatments targeting multiple areas of the scalp. Treatments last about 10 to 15 minutes and follow a protocol that includes topical anesthetic and antiseptic cleaning before the laser application. Post-treatment care includes applying a topical steroid cream. Follow-up visits are scheduled at months 6, 9, 12, and 15 to monitor progress. Throughout the study, researchers will conduct clinical assessments including standardized photography and hair density measurements using the Canfield HairMetrix® device. Participants will complete questionnaires to report pain levels, hair growth self-assessments, and any adverse events. Primary outcomes include live and photographic assessments of hair loss, hair density, and hair counts at multiple timepoints up to month 15. Subject satisfaction will also be tracked. The study duration allows careful monitoring of changes and safety over more than a year.

Researchers are evaluating litifilimab (BIIB059), a monoclonal antibody, in adults with active cutaneous lupus erythematosus (CLE). This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus (SLE), who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts: Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are evaluating VENT-03, an oral tablet, to treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study aims to understand if VENT-03 affects CLE activity and severity, assess its safety, and learn how the body processes the drug. This Phase 2a trial compares VENT-03 to a placebo to determine its effects on the skin's interferon gene signature and disease severity. Participants will be randomly assigned to receive either VENT-03 or a placebo tablet daily for 4 weeks during a double-blind period. After this, all participants will take VENT-03 for an additional 8 weeks in an open-label extension. Clinic visits will occur monthly for checkups, tests, and to monitor treatment effects and side effects. During the study, participants will undergo skin biopsies and lab tests to evaluate immune markers and drug levels in the body. Researchers will track disease severity changes and record any side effects or adverse events throughout the 12-week treatment period. Safety assessments and drug concentration measurements will be done at set times to understand how VENT-03 is absorbed and tolerated.

Researchers are evaluating the effectiveness and safety of enpatoran in adults with active skin symptoms of lupus erythematosus, with or without systemic disease. This global, multicenter Phase 3 study aims to understand how well enpatoran works over 24 weeks compared to a placebo, while participants continue their standard care for lupus. The study is sponsored by EMD Serono Research & Development Institute, Inc. Participants will be randomly assigned to receive either enpatoran tablets or placebo tablets taken orally twice daily from Day 1 through Day 168. The study treatment lasts 24 weeks, with visits scheduled every 4 weeks, except for a Week 2 telemedicine visit. Standard of care treatment will be provided alongside the study medication during this period. During the study, participants will have regular visits to assess their skin lupus disease activity using the CLASI score and other lupus activity measures. Researchers will monitor safety by tracking adverse events and laboratory tests. The main outcome is the percentage of participants achieving a 70% improvement in their skin lupus severity after 24 weeks. Overall participation can last up to 35 weeks, including screening and follow-up assessments.

Researchers are evaluating the safety and effectiveness of Enpatoran in adults with active skin symptoms of lupus erythematosus, including those with or without systemic disease. This global, multicenter Phase 3 study aims to better understand how Enpatoran affects the severity of cutaneous lupus over 24 weeks of treatment. The study is sponsored by EMD Serono Research & Development Institute, Inc., and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either Enpatoran or a matching placebo, taken orally twice daily for 24 weeks, alongside standard care recommended by their investigators. The study includes regular visits every 4 weeks, with one televisit at Week 2. The study medication is in the form of film-coated tablets. The total study duration can last up to 35 weeks, including treatment and follow-up. During the study, participants will undergo assessments of their skin disease severity using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and other lupus activity measures. Researchers will monitor adverse events, changes in laboratory tests, and symptom changes such as itch severity and skin inflammation. The main outcome measured is the percentage of participants achieving at least a 70% improvement in cutaneous lupus symptoms at Week 24. Safety and tolerability will also be carefully observed throughout the study period.

Researchers are evaluating how mosunetuzumab works in adults with systemic lupus erythematosus (SLE), including those who may also have active lupus nephritis (LN). This Phase II open-label study aims to assess the effectiveness, safety, and how the drug moves through the body in this patient group. The study is sponsored by Hoffmann-La Roche and focuses on important measures like remission rates and kidney response over time. Participants will receive mosunetuzumab through subcutaneous (under the skin) injections. The treatment period includes monitoring up to 2.5 years, with assessments of remission by Week 76 and kidney responses at several time points up to Week 104. The study does not involve placebo or masking, allowing all participants to receive the active drug. During the study, participants will undergo various evaluations including blood tests for drug levels, immune markers, and infection monitoring. They will also complete fatigue and disease activity assessments. Safety is closely monitored, including adverse events and immune responses. The overall study participation may last up to 2.5 years, with regular visits to track progress and outcomes.

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 skin's 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 evaluating the use of CART19, a CD19-directed chimeric antigen receptor autologous T cell therapy, in children and young adults aged 12 to 29 years with refractory Systemic Lupus Erythematosus (SLE), including those with lupus nephritis (LN) and non-renal SLE. This phase 1/2 open-label study aims to assess the safety and effectiveness of CART19 cells, which are designed to deeply reduce B cells that play a central role in lupus activity. Previous treatments targeting CD19 have had mixed results, and this trial explores a new cellular therapy approach that may lead to remission without ongoing immunosuppression. Participants will receive an intravenous infusion of the study treatment, which consists of CART19 cells engineered via a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ. The study includes a phase 1 safety evaluation with dose de-escalation if needed, followed by a phase 2 assessment of effectiveness and safety. The treatment is given once, and patients will be monitored for up to 24 months after infusion to assess outcomes and side effects. During the study, participants will undergo regular assessments including laboratory tests, clinical evaluations, and monitoring of CART19 cell behavior such as expansion and persistence in the body. Researchers will measure the frequency of dose-limiting toxicities, rates of clinical remission without steroids, renal response, survival, flare-free survival, cytokine levels, and the feasibility of producing CART19 cells. Safety follow-up and detailed monitoring will occur throughout the two-year period after treatment to understand the long-term effects and impacts of CART19 therapy.

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 participant's 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.