Leawood

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are evaluating the safety and effectiveness of upadacitinib, an oral medication, in adults and adolescents with moderate to severe hidradenitis suppurativa HS who have not responded well or are intolerant to anti-tumor necrosis factor TNF therapy. HS is a painful inflammatory skin disease affecting areas such as the underarms, groin, and analgenital regions. This phase 3 study is double-blinded, meaning neither participants nor doctors know who receives upadacitinib or placebo. The trial includes three periods and involves about 1328 participants worldwide. Participants will take oral tablets of upadacitinib or placebo once daily for 36 weeks during the first two periods. In Period 1, they are randomly assigned to receive either upadacitinib Dose A or placebo for 16 weeks. In Period 2, based on their response in Period 1, participants are divided into six groups receiving various combinations of upadacitinib doses or placebo for 20 weeks. Eligible participants continue to Period 3, a long-term extension, taking upadacitinib or placebo daily for 68 weeks, followed by a 30-day follow-up. During the study, participants will have regular outpatient visits for medical assessments, side effect monitoring, and questionnaires to track changes in disease activity and adverse events. The main outcomes include the percentage achieving clinical response HiSCR 50 by week 16 and the number of adverse events up to week 108. Secondary outcomes measure changes in draining fistula count, symptom assessments, skin pain, odor, quality of life, and flare occurrence. This thorough monitoring helps evaluate treatment impact and safety over time.

Alopecia areata AA is a condition where the immune system attacks hair follicles causing hair loss, typically on the head and face but possibly anywhere on the body. This research aims to evaluate how safe, effective, and tolerable the drug upadacitinib is for adolescents and adults with severe AA. The study is a Phase 3 randomized, placebo-controlled trial involving about 1500 participants worldwide with severe AA, sponsored by AbbVie. Participants will be randomly assigned to one of three groups receiving either one of two doses of upadacitinib or a placebo. In the initial period, some participants receive placebo for 24 weeks, then based on their hair loss severity measured by the Severity of Alopecia Tool SALT score, they may be re-randomized to continue placebo or start one of the upadacitinib doses. Those on upadacitinib continue their assigned dose. Participants who complete the first studies can join an extension study with upadacitinib treatment for up to 108 weeks. Tablets are taken orally once daily for up to 160 weeks. Throughout the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in hair loss using the SALT score and track any adverse events during treatment and up to 30 days after the last dose. The study also evaluates other patient-reported outcomes related to hair growth and quality of life over time.

Researchers are evaluating the Freenome Multiomics Blood Test as a new way to screen for lung cancer in people at high risk. This observational study includes adults aged 50 and older who are current or former smokers with a significant smoking history. The goal is to see how well this blood test works alongside the standard Low-Dose Computed Tomography LDCT screening to detect lung cancer early. Participants will provide a blood sample of 50 ml that will be tested and stored by Freenome or its designee. They will also undergo a standard LDCT chest scan, ideally on the same day as the blood draw or within 45 days afterward. The study collects additional information such as medical history, lifestyle, environmental exposures, and results from diagnostic tests related to lung cancer detection. Participants will be monitored for at least 24 months following their baseline chest CT scan to track health outcomes. Researchers will review clinical data, imaging reports, and lab results during this period. The main outcome measured is the blood tests sensitivity and specificity in detecting lung cancer at 12 months, with additional measurements at 24 months. The study may end early if participants withdraw or pass away.

Researchers are evaluating the study medicine called elranatamab in people with multiple myeloma MM that has returned or not responded to previous treatments, including prior anti-CD38 antibody and lenalidomide therapies. This Phase 3 trial aims to compare elranatamab with other commonly used combination therapies to understand its safety and how well it works for people with relapsed or refractory MM. Participants will be randomly assigned to receive either elranatamab alone or an investigators choice of combination therapies. Elranatamab is given as a weekly shot under the skin at the study clinic, which may become less frequent later. The combination therapies include various medicines taken by mouth and given as shots or intravenous infusions at the clinic. Treatment continues until the MM no longer responds. During the study, participants will visit the clinic regularly for monitoring and assessments, including evaluations of disease progression and response to treatment. Follow-up contacts by telephone or visits will continue after treatment ends. The main measure is progression-free survival, and other outcomes include overall survival, response rates, quality of life, and safety. The study may last up to about five years for some measures.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication LSS with NC in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression IPD. The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the studys NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are evaluating the pharmacokinetics, safety, and effectiveness of povorcitinib in adolescents aged 12 to 17 years with moderate to severe hidradenitis suppurativa. This phase 2, open-label study aims to understand how the drug behaves in the body and its impact on this skin condition over a 54-week period. Participants have moderate to severe disease and have not responded adequately to previous systemic treatments. Participants will be assigned to receive one of two doses of povorcitinib orally as tablets for 54 weeks. The study monitors how the drug is absorbed, distributed, and cleared from the body during the first 24 weeks, while safety and skin condition responses are assessed throughout the full treatment period. The study does not use randomization or blinding. During the study, participants will undergo regular evaluations including monitoring of treatment-emergent adverse events and measurement of drug levels in the blood. Researchers will also assess changes in skin lesions, abscesses, draining tunnels, and skin pain using standardized clinical response criteria and quality of life questionnaires. This comprehensive monitoring helps understand the drugs safety and impact over the 54-week treatment period.

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.