Riverdale

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

Researchers are evaluating the safety and effects of a study medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. This condition makes breathing difficult and affects quality of life. The study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to determine if PF-07275315 is safe and effective for this group. Participants will receive either PF-07275315 or a placebo through multiple subcutaneous injections administered in the clinic over 12 weeks. The study compares these two groups to assess treatment responses. The trial includes a total of 9 clinic visits and lasts about 7.5 months for each participant. During the study, participants will undergo various assessments including lung function tests to measure forced expiratory volume in 1 second (FEV1), safety monitoring through adverse event tracking, laboratory tests, vital sign checks, and electrocardiograms. These evaluations occur from baseline through 24 weeks to observe changes and treatment tolerability.

Researchers are evaluating the safety of DBV712 250 micrograms (mcg) epicutaneous immunotherapy in children aged 1 to 3 years with peanut allergy. This Phase 3, randomized, double-blind, placebo-controlled study aims to observe adverse events over a 6-month treatment period. The study includes participants diagnosed by a physician with peanut allergy, confirmed by specific tests and a strict peanut-free diet. Participants will be randomly assigned in a 3:1 ratio to receive either the DBV712 250 mcg active treatment or a matching placebo patch applied to the skin. The study consists of a 6-week screening period, a 26-week double-blind treatment period, followed by an optional 18-month open-label extension where all participants can receive the active treatment. During the study, participants will be monitored for adverse events, treatment-emergent adverse events, and serious adverse events throughout the 6-month double-blind treatment period. The total study duration for each child is about 112 weeks, including follow-up assessments. Researchers will carefully evaluate safety outcomes and adherence to the treatment regimen to ensure participant well-being.