Litchfield Park

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

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 studying how well lebrikizumab works for adolescents and adults with moderate atopic dermatitis (eczema) who have a high level of itchiness and limited areas affected on the body. The study focuses on participants who have had eczema for at least one year and aims to measure improvements in skin condition and itch severity. This is a Phase 4, open-label, single-arm trial involving individuals aged 12 and older. Participants will receive lebrikizumab through subcutaneous injections. The treatment period lasts for 24 weeks (6 months), during which the medication is administered as per the study protocol. The entire participation, including screening and follow-up, spans approximately 38 weeks (9 and a half months). During the study, participants will undergo regular assessments including skin evaluations and itch severity ratings to track changes from baseline. Researchers will measure the percentage of participants achieving at least a 75% improvement in eczema severity or a 4-point reduction in itch intensity by week 16. Safety and adherence to treatment will also be monitored throughout the study duration.

This research aims to evaluate the safety and effectiveness of additional doses of ADX-324 in people with Type I and Type II hereditary angioedema (HAE). It is a Phase 3 extension study following the completion of a previous trial (ADX-324-301). The study also assesses pharmacodynamic, pharmacokinetic, and health-related quality of life measures to better understand the treatment's impact. Participants will receive one of two doses of ADX-324, a small interfering RNA (siRNA) duplex oligonucleotide targeting prekallikrein. This extension study follows the initial phase and continues monitoring participants who have completed the earlier trial. The treatments are given to assess safety and continued efficacy over an extended period. During the study, participants will be regularly monitored for safety, including evaluations of how the drug is processed in the body and its biological effects. Health-related quality of life will be assessed to understand the treatment's impact on daily living. The primary outcome is the safety of ADX-324 measured at 36 months, ensuring long-term monitoring of participants who have access to acute therapies for HAE attacks.

Researchers are evaluating the effectiveness and safety of ADX-324, a siRNA duplex oligonucleotide, in adults with Type 1 or Type 2 hereditary angioedema (HAE). This Phase 3, randomized, double-blind, placebo-controlled study aims to prevent HAE attacks and also assess the drug's pharmacokinetics, pharmacodynamics, and impact on health-related quality of life. Participants will receive either ADX-324 or a placebo (saline) during the study. The study treatment period focuses on evaluating the efficacy of ADX-324 in preventing HAE attacks from Day 22 to Week 25. The study compares the investigational drug with a placebo to determine its potential benefits and safety profile. Throughout the study, participants will be monitored for HAE attack frequency and other health measures. Researchers will assess treatment effects, safety, and quality of life using clinical evaluations and laboratory tests. Participants must be at least 18 years old and have a documented diagnosis of HAE-1 or HAE-2, with confirmed recent attacks and the ability to use acute therapies for treatment. The study focuses on participant well-being while closely observing the investigational medication's effects.