Clarksville

Researchers are evaluating the safety and effectiveness of oral brepocitinib in adults with lichen planopilaris, a condition affecting the scalp. This Phase 23 trial aims to understand how well this medication works compared to a placebo in treating active and symptomatic lichen planopilaris. The study is sponsored by Priovant Therapeutics, Inc. and uses a randomized, double-blind design to ensure reliable results. Participants are randomly assigned to receive either oral brepocitinib or a placebo. The study is conducted in parallel groups, with neither the participants nor the researchers knowing who receives the active drug or placebo. The treatment period lasts 24 weeks, during which the participants take the assigned oral medication. The main goal is to measure improvement in the Investigator Global Assessment IGA score by Week 24. Throughout the study, participants will be regularly monitored for safety and symptom changes. Researchers will assess the proportion of participants who achieve significant improvement in their IGA scores at Week 24 and track changes in symptom severity using a numerical rating scale. The total study duration extends until July 2029, allowing for thorough evaluation of treatment effects and safety over time.

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 the safety and effectiveness of D-2570 in adults with moderate to severe plaque psoriasis. This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to assess how well D-2570 works and how safe it is for participants with this skin condition. The study focuses on participants who have had stable disease without major flares for at least six months. Participants will be randomly assigned to receive either a low dose or a high dose of D-2570 tablets, or placebo tablets that look identical. Treatments are given over a 12-week period, during which participants and researchers will monitor their responses to the study drug or placebo. The study uses a quadruple-blind design where participants, care providers, investigators, and outcome assessors do not know which treatment is given. During the study, participants will undergo various assessments including measurement of psoriasis severity using the Psoriasis Area and Severity Index PASI, Physicians Global Assessment PGA, and evaluation of body surface area affected. The primary outcome is improvement in PASI-90 after 12 weeks of treatment or placebo. Laboratory tests and safety monitoring will also be performed throughout the study to track any changes and ensure participant safety.

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.

Researchers are evaluating the safety and effectiveness of VDPHL01, an investigational oral drug, in female subjects with Androgenetic Alopecia AGA, a genetic condition causing hair loss due to an excessive response to hormones called androgens. This Phase 3, multi-center, double-blind study aims to better understand treatment outcomes for women aged 18 to 65 with mild to moderate AGA. The study is sponsored by Veradermics, Inc. and includes about 13 months of participation with 11 scheduled visits. Participants will be randomly assigned to one of several groups receiving different regimens of VDPHL01 or placebo. Some groups take VDPHL01 twice daily BID for the entire 12 months, while others begin with placebo or a combination of VDPHL01 once daily QD and placebo before switching treatments after 6 months. The study maintains a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the first 6 months. Throughout the study, participants will attend visits for screening, baseline assessment, and follow-ups at weeks 2, months 1, 2, 4, 6, 8, 10, 12, and 13. Researchers will evaluate hair counts in target areas at 6 months and participants own assessment of treatment benefit. Participants agree to maintain consistent hair length, style, and color, and will have a small tattoo placed on their scalp for photographic monitoring. Safety and treatment effects will be carefully monitored during the study period.

Researchers are evaluating the safety and effectiveness of ENV-294 in adults with moderate to severe atopic dermatitis. The study aims to find out if ENV-294 can reduce the severity and area affected by atopic dermatitis and to monitor any medical problems participants may experience while taking the drug. This is a phase 2, randomized, double-blind, placebo-controlled trial sponsored by Enveda Therapeutics. Participants will take either ENV-294 or a placebo once daily by mouth for 12 weeks. Those in the treatment arm will receive ENV-294 tablets, while those in the placebo arm will receive matching tablets without the active drug. Participants will visit the clinic every 2 to 4 weeks for checkups and tests during the treatment period. After 12 weeks, participants will return to the clinic for a final study visit at about week 16. During the study, participants will keep a diary to record their symptoms and study drug intake. Researchers will assess the severity and extent of atopic dermatitis, monitor adverse events, and evaluate patient-reported outcomes and pharmacokinetics of ENV-294 from baseline through week 12. Safety and effectiveness will be closely monitored throughout the trial, with a total participation duration of approximately 16 weeks.

This research aims to assess the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment phase followed by an open-label extension. The goal is to better understand how well deuruxolitinib works and how safe it is for this age group with significant hair loss. Participants will be randomly assigned to receive either deuruxolitinib tablets or matching placebo tablets taken orally twice daily for 24 weeks during the initial treatment period. Following this, all participants will have the opportunity to receive deuruxolitinib for an additional 52 weeks in an open-label extension phase. This design allows comparison of the drug to placebo and longer-term evaluation of the drugs effects. Throughout the study, participants will have regular assessments of their hair loss using the Severity of Alopecia Tool SALT at multiple time points up to week 24 and beyond. Safety will be closely monitored by tracking side effects, vital signs, heart tests, lab results, and physical exams. Additional measurements include patient and clinician impressions of improvement, quality of life, and mental health assessments. The total study duration can extend up to 76 weeks of treatment plus safety follow-up to fully evaluate outcomes and tolerability.