Clifton

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

Researchers are evaluating Rezpegaldesleukin, a drug being studied for patients aged 12 years and older with moderate to severe atopic dermatitis. This Phase 3, randomized, double-blind study compares Rezpegaldesleukin to a placebo to assess its effect on the condition. The study is designed as a parallel group trial and aims to understand treatment outcomes over approximately 15 months. Participants receive Rezpegaldesleukin injections subcutaneously during an induction period every 2 weeks and then during a maintenance period at varying intervals of every 4 or 12 weeks. Some participants will receive placebo injections on a similar schedule during the induction and maintenance periods. An open-label escape phase allows dosing frequency to be adjusted by the investigator. The study includes both blinded and open-label phases to monitor responses. During the study, participants will undergo regular assessments including Investigators Global Assessment IGA scores, Eczema Area and Severity Index EASI scores, and symptom rating scales for itch, skin pain, and sleep impact. Researchers will also track asthma control and sinusitis symptoms in applicable patients. Safety is monitored through reports of adverse events throughout the study. The total participation time is about 15 months, with key evaluations at weeks 0, 6, 24, and ongoing safety follow-ups.

Researchers are evaluating the effectiveness, safety, and drug levels of Deucravacitinib BMS-986165 in adolescents aged 12 to less than 18 years who have moderate to severe plaque psoriasis. This phase 3 study is randomized, double-blind, and placebo-controlled to thoroughly assess the treatments impact on this skin condition. The study is sponsored by Bristol-Myers Squibb and aims to provide detailed information on how Deucravacitinib works in this younger population. Participants will receive either Deucravacitinib or a placebo, with doses given on specified days as part of the treatment. The study groups include an active drug group and a placebo group, and the design is parallel to compare these treatments directly. The treatment period includes monitoring drug levels and observing the participants responses over time. During the study, participants will be regularly assessed for improvements in their psoriasis using measures such as the Psoriasis Area and Severity Index PASI and the static Physicians Global Assessment sPGA at week 16. Additional evaluations include body surface area involvement, itch severity, quality of life, and antibody protection. Safety is closely monitored through laboratory tests, physical exams, vital signs, and adverse event tracking for up to five years, with ongoing measurement of growth and sexual maturation during this time.

Researchers are evaluating Barrigel, a biodegradable gel designed to create space between the anterior rectal wall and the prostate or prostate bed during radiotherapy for prostate cancer patients who have had a prostatectomy and now face cancer recurrence. The goal is to reduce radiation exposure to the rectum by positioning it away from the radiation target area. This prospective, randomized, controlled, single-masked multicenter study focuses on men receiving intensity-modulated external beam radiation therapy for this condition. Participants will be randomly assigned to one of two groups. One group will receive an injection of Barrigel between the rectum and prostate bed guided by transrectal ultrasound, while the control group will undergo a sham procedure involving insertion of a transrectal ultrasound probe without Barrigel injection. Barrigel is made of absorbable material and maintains the created space throughout the radiation therapy course before gradually being absorbed by the body. During the study, participants will undergo assessments including imaging and quality of life questionnaires at set intervals, particularly three months after treatment. Researchers will measure the reduction in the volume of rectum exposed to radiation, monitor grade 2 toxicities, and evaluate bowel and urinary quality of life using the Expanded Prostate Cancer Index Composite. Safety and adherence to the study protocol will be closely monitored throughout the treatment and follow-up periods.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

This research aims to evaluate the Shield blood tests performance for colorectal cancer CRC screening in people aged 45 to 81 who are at average risk for CRC. The study focuses on assessing the test during a second round of screening, using colonoscopy as the reference standard. CRC is a common and serious disease, especially affecting older adults and certain minority groups, with early detection being key to improving outcomes. Participants will undergo the Shield blood test as part of their routine standard care, and their results will be compared to colonoscopy findings. This study is observational and collects real-world evidence over a period of 33 to 42 months after enrollment to assess how well the Shield test performs in detecting CRC or its precursors during the second screening interval. Participants will be involved in scheduled study procedures and standard care assessments, with data collected on the tests accuracy and effectiveness over time. The main outcome measured is the performance of the Shield test during the second testing period. The study will continue until December 2030, monitoring participants to gather long-term information about CRC screening efficacy in an average-risk population.