Slomniki

Researchers are evaluating the effects of BMS-986368, a FAAH/MAGL inhibitor, on spasticity in people with Multiple Sclerosis (MS). This Phase 2 study aims to assess the drug's efficacy, safety, and tolerability by comparing three different doses of BMS-986368 to a placebo in participants who have experienced MS-related spasticity for at least six months. Participants will receive oral doses of BMS-986368 or placebo at specified times. The study includes four groups: three groups receive different doses of BMS-986368, and one group receives a placebo. Treatment is administered according to a set schedule, and the trial is conducted at multiple centers with a double-blind design to ensure unbiased results. During the study, participants' spasticity levels will be measured using the Total Numeric-transformed Modified Ashworth Scale focusing on the most affected lower limb at week 6. Additional evaluations include safety and tolerability assessments. Participants are monitored throughout the treatment period for changes in spasticity and any side effects. The study includes adults aged 18 to 70 years with specific MS-related disability and spasticity criteria.

Researchers are evaluating the safety and appropriate dosing of two drugs, Iberdomide (CC-220) and CC-99282, combined with the standard R-CHOP-21 chemotherapy regimen for treating adults with aggressive B-cell lymphoma who have not received prior treatment. This Phase 1b study includes two parts: Part 1 focuses on finding the best tolerated doses of CC-220 or CC-99282 added to R-CHOP-21, and Part 2 involves a randomized dose expansion using the recommended Phase 2 dose (RP2D). An additional group will explore combining polatuzumab vedotin with CC-220 or CC-99282 and R-CHOP-21 after the RP2D is established. In Part 1, participants receive either CC-220 or CC-99282 by mouth for specified days within each 21-day treatment cycle, alongside the R-CHOP-21 regimen, which includes Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone administered via intravenous infusion or orally according to standard schedules for up to six cycles. Part 2 will test the recommended doses of CC-220 and/or CC-99282 combined with R-CHOP-21, and may add polatuzumab vedotin in new participant cohorts. Treatment cycles last 21 days, with specific dosing days for each drug. Participants will be closely monitored throughout the study for safety, tolerability, and dose recommendations. Assessments include laboratory tests, physical exams, and evaluations of side effects and responses during treatment cycles. The primary outcomes measured are maximum tolerated dose and recommended Phase 2 dose during early treatment cycles, as well as safety and tolerability from first dose until 28 days after the last dose. Participants' involvement may last through multiple cycles with ongoing monitoring to evaluate the treatments' effects on lymphoma.