Victoria Park

Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in adults with moderate to severe Systemic Lupus Erythematosus SLE. This Phase 1b open-label pilot study aims to assess the safety and tolerability of CLN-978 in patients who have active SLE with inadequate response to standard treatments, including corticosteroids, antimalarials, immunosuppressants, or biologics. The study is sponsored by Cullinan Therapeutics Inc. and plans to enroll adults aged 18 to 70 years. Participants will receive CLN-978 administered by subcutaneous injection in two parts Part A involves dose escalation cohorts to determine safe dosing levels, and Part B further evaluates treatments at higher doses or extended schedules for eligible patients from Part A. The treatment duration includes up to 48 weeks of monitoring with specified dosing days. Patients must meet defined laboratory and disease activity criteria to participate, and those in Part B must have had no dose-limiting toxicity or treatment discontinuation in Part A and wait at least 90 days after the last dose. During the study, participants will undergo regular safety and tolerability assessments, including laboratory tests to monitor blood cell counts, kidney and liver function, and immune response markers. Pharmacokinetics, immunogenicity, and pharmacodynamics biomarkers related to treatment effects will also be evaluated over 48 weeks. The study aims to monitor adverse events closely and ensure ongoing assessment of treatment impact on disease activity and patient well-being throughout the trial.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Psoriatic arthritis PsA is a chronic inflammatory condition affecting the joints and skin. This trial evaluates the long-term safety, tolerability, and effectiveness of the drug zasocitinib in adults with active PsA, including those who have not previously used biologic DMARDs or those with inadequate response to biologic DMARDs. The study is a phase 3, multicenter, randomized, quadruple-blind trial designed as a long-term extension to previous parent studies, focusing on continued treatment with zasocitinib. Participants who completed a 52-week treatment in one of the parent studies may join this continuation study. All participants will receive oral zasocitinib once daily at one of two doses Dose A or Dose B for up to 104 weeks. Those previously assigned to zasocitinib will continue their dose, and those previously on an active comparator will be re-randomized to one of the zasocitinib doses. After treatment, a 4-week follow-up period will monitor health. During the study, participants will undergo regular safety assessments including monitoring of adverse events, vital signs, and laboratory values up to week 108. Effectiveness will be evaluated by measuring response criteria such as ACR20, ACR50, ACR70, minimal disease activity, and improvements in skin symptoms at weeks 24, 48, and 104. The entire participation period is approximately two years, including treatment and follow-up to ensure comprehensive long-term data collection.