Fairport

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating VENT-03 to see if it can treat adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). The study also aims to learn about the safety of VENT-03 and how the body processes it. Participants will be compared to those receiving a placebo to determine if VENT-03 affects disease activity and severity, as well as to monitor any side effects. Participants will take either VENT-03 tablets or placebo tablets for 4 weeks in a double-blind phase. After this, all participants will switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study involves monthly clinic visits for checkups and tests throughout the treatment periods. During the study, researchers will assess the effect of VENT-03 on the interferon gene signature in the skin from baseline to the end of the double-blind treatment (up to Day 28). Participants will have regular evaluations including clinical assessments and safety monitoring to track how the treatment affects their condition and to watch for any side effects or adverse events over the total duration of the study.

This Phase 3 study investigates the use of HyBryte, a topical gel containing 0.25% hypericin, combined with visible light therapy to treat patients diagnosed with patch/plaque phase cutaneous T-cell lymphoma (CTCL), including stages IA, IB, or IIA. The goal is to evaluate whether an 18-week treatment course can induce a treatment response compared to placebo gel with visible light. The study focuses on assessing disease severity changes in selected skin lesions using a modified Composite Assessment of Index Lesion Severity (mCAILS) score. Participants receive either HyBryte gel or placebo gel applied twice weekly to all readily accessible lesions for 18 weeks. After application, treated areas are covered with opaque material, such as clothing, and about 21 hours later, participants undergo visible light exposure. Three to five index lesions per participant are identified and monitored throughout the study to evaluate treatment effects. Following the 18-week treatment period, participants are followed every 4 weeks for an additional 12 weeks to monitor ongoing outcomes. Throughout the study, several assessments are performed including evaluation of lesion severity using mCAILS, monitoring of safety and adverse effects, and documentation of treatment response at 18 weeks. The study closely tracks participants' adherence to treatment schedules and visible light exposure protocols. The total participation duration spans 30 weeks, including the treatment and follow-up periods, allowing comprehensive evaluation of HyBryte's effects on CTCL skin lesions.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.