Westville

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating barzolvolimab in a Phase 3, randomized, double-blind, placebo-controlled study for adults with cold induced urticaria or symptomatic dermographism who continue to have symptoms despite using H1-antihistamines. The study aims to assess the safety and activity of barzolvolimab compared to a placebo in these participants. Participants must have a diagnosis of these conditions for at least 3 months and meet specific diagnostic criteria related to provocation testing and symptom severity. The study includes a screening period of up to 4 weeks, followed by a 24-week treatment period where participants receive either barzolvolimab or placebo by subcutaneous injection. Those on barzolvolimab receive a 450mg dose at the start and then 150mg every 4 weeks. After this, there is a 28-week treatment phase where all participants receive 300mg barzolvolimab every 8 weeks. Finally, a 16-week follow-up period observes all participants without treatment. During the study, participants will complete daily symptom electronic diaries and attend regular study visits. Researchers will monitor safety through blood counts, liver function tests, and provocation testing to measure response. The main outcome measured is the complete response to provocation testing at Week 12 from the first dose. The total study duration includes screening, treatment, and follow-up phases to evaluate long-term safety and effectiveness.

Researchers are evaluating whether different doses of the medicine called BI 3000202 can help adults with moderate to severe systemic lupus erythematosus (SLE). This phase II study is designed to find the best dose of BI 3000202 for people living with this condition. Participants must have a confirmed diagnosis of SLE with specific disease activity and antibody markers. Participants are randomly divided into five groups. Four groups receive varying doses of BI 3000202, while one group receives a placebo that looks like the real medicine but contains no active drug. All participants continue their usual SLE treatments during the study. The tablets are taken daily for one year. During the study, participants visit the study site regularly for health checkups and to monitor any side effects. Researchers measure the treatment's effectiveness by the achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response at week 32. The total participation time is a bit longer than one year, during which safety and health are closely observed and compared between groups.