Litchfield Park

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab as add-on treatments for adults with moderate to severe chronic spontaneous urticaria CSU that is not well controlled by second generation H1-antihistamines sgH1-AH. This Phase 3b, multi-center, randomized, double-blind, double-dummy study focuses on early treatment effects within 4 weeks. The study addresses the need for better management of CSU symptoms such as hives and itch. Participants will be assigned to one of two treatment groups one group will receive remibrutinib tablets twice daily plus placebo injections, while the other group will receive dupilumab injections with matching placebo tablets. Both groups continue their stable background therapy of sgH1-AH daily. The study includes a screening period up to 4 weeks, a 12-week core double-blind treatment period, and an optional 12-week open-label extension where all participants may receive remibrutinib if it is not commercially available. After treatment, safety follow-up occurs for up to 12 weeks, with phone calls and possible site visits. Participants will be monitored through regular assessments including symptom severity scores, urticaria activity scores, and daily diaries. Safety follow-up includes phone calls and visits depending on treatment continuation. The main outcome is the change in weekly urticaria activity score at Week 4. Other measures include severity of hives and itch at Weeks 1 and 4. Total study participation may last up to 24 weeks, including optional extension and follow-up phases.

Researchers are studying an extension of a Phase 3 clinical trial to evaluate additional dosing of ADX-324 in adults with Type I or Type II hereditary angioedema HAE. This study aims to provide further information on the safety and effectiveness of ADX-324, a siRNA duplex oligonucleotide drug, in preventing HAE attacks while also assessing its impact on participants quality of life. Pharmacodynamic and pharmacokinetic data will also be collected to understand how the drug behaves in the body. Participants who completed the initial Phase 3 ADX-324-301 trial will receive either of two dose levels of ADX-324 in this extension study. The study will monitor the effects of these doses over time, with participants continuing to have access to acute therapies for treating HAE attacks if needed. The trial uses a double-blind design where neither participants nor researchers know which dose level is administered. During the study, participants will be closely monitored for safety and efficacy outcomes over a period extending to 36 months. Researchers will measure the safety of ADX-324 and evaluate its effectiveness in preventing HAE attacks. Health-related quality of life assessments and pharmacokinetic and pharmacodynamic measurements will also be conducted. The total duration of participation is expected to last until the studys completion in 2030.

Researchers are evaluating the efficacy and safety of ADX-324 in adults diagnosed with Type 1 or Type 2 hereditary angioedema HAE. This Phase 3 study also assesses pharmacokinetics, pharmacodynamics, and the impact on health-related quality of life measures for participants with this condition. The trial is sponsored by ADARx Pharmaceuticals, Inc. and aims to prevent HAE attacks while understanding the drugs overall effects. Participants are randomly assigned to one of three groups two different dose levels of ADX-324, which is an siRNA duplex oligonucleotide drug, or a placebo containing saline. The study uses a quadruple-blind design to evaluate the treatments over a period from Day 22 to Week 25. The trial includes screening to confirm eligibility and monitors participants closely while receiving the study drug or placebo. During the study, participants undergo regular assessments to measure the frequency and quality of HAE attacks, safety evaluations, and collect data on drug behavior in the body. Researchers also observe pharmacodynamics and health quality of life changes. The primary outcome focuses on preventing HAE attacks within the main treatment period, with secondary outcomes exploring attack characteristics. The total study duration extends through the treatment and monitoring phases until study completion in late 2027.