Leawood

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

Researchers are evaluating the safety, effectiveness, and tolerability of upadacitinib in adolescents and adults with severe alopecia areata (AA), a condition where the immune system attacks hair follicles causing hair loss on the head, face, or other body parts. This phase 3 study involves about 1500 participants worldwide and compares upadacitinib to a placebo to assess treatment impact on severe AA. Participants are randomly assigned to one of three groups receiving either upadacitinib or placebo oral tablets once daily for up to 160 weeks. There is a chance for re-randomization at weeks 24 and 52 based on Severity of Alopecia Tool (SALT) scores. Those completing initial studies may join an extension study to receive upadacitinib for up to an additional 108 weeks. Follow-up occurs for 30 days after the last dose. Throughout the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers measure the percentage of participants achieving a SALT score of 20 or less at week 24 and track adverse events up to 164 weeks. The study may involve a higher treatment burden compared to usual care due to frequent visits and evaluations.

Researchers are evaluating the Freenome Multiomics Blood Test as a tool to help detect lung cancer earlier in people at high risk. This prospective, multi-center observational study involves participants eligible for standard lung cancer screening using a low-dose computed tomography (LDCT) scan. The study collects blood samples and compares the test's results with routine screening to see how well the blood test detects lung cancer over time. Participants who qualify and consent will have 50 ml of blood drawn for analysis by Freenome or its designee. Blood collection is done within 30 days of consent, and ideally on the same day as the LDCT screening, but up to 45 days after blood collection is allowed for the scan. The study collects detailed clinical and demographic information, including medical history, lifestyle, family history, and exposure risks, along with diagnostic and follow-up imaging and pathology reports related to lung cancer diagnosis. Participants will be followed for at least 24 months from their initial screening CT scan or until early study exit due to withdrawal or death. The researchers will monitor the sensitivity and specificity of the blood test in detecting lung cancer during this period. All clinical data, imaging, lab tests, and outcomes related to lung cancer diagnosis will be carefully recorded and analyzed to evaluate the blood test's performance.

Researchers are evaluating a medicine called elranatamab for the treatment of multiple myeloma (MM), a type of cancer. This study focuses on people aged 18 or older who have MM that has returned or not responded to previous treatments, including prior use of an anti-CD38 antibody and lenalidomide. The goal is to compare elranatamab to other common combination therapies that include 2 to 3 different MM medicines. This is a Phase 3 study to learn about the safety and effectiveness of elranatamab compared to these other treatments. Participants will be randomly assigned to receive either elranatamab or a combination therapy selected by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, which may later reduce in frequency. The combination therapy options include medicines taken by mouth and given either as shots under the skin or through a needle in the vein at the clinic. The combination medicines used may be elotuzumab, pomalidomide, dexamethasone, bortezomib, or carfilzomib, depending on the chosen treatment plan. Participants may continue their assigned treatment until their MM stops responding. During the study, participants will visit the clinic regularly for monitoring and evaluation. Researchers will track how well the treatments work by measuring progression-free survival and will watch for any side effects or safety concerns. Follow-up will continue after treatment ends through phone calls or visits. The study may last up to about 5 years to fully assess the outcomes of the treatments.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the pharmacokinetics, safety, and effectiveness of povorcitinib in adolescents aged 12 to under 18 years who have moderate to severe hidradenitis suppurativa. This Phase 2, open-label study focuses on this skin condition over a 54-week treatment period to better understand how the drug behaves in the body and its potential benefits and risks for this age group. Participants will receive povorcitinib as an oral tablet throughout the study. The treatment period lasts 54 weeks, during which the participants take the medication and are monitored closely. The study does not mention comparator groups or placebo, focusing solely on povorcitinib administration and its effects. During the study, participants will be regularly assessed for treatment-emergent adverse events and various pharmacokinetic parameters such as drug clearance, absorption, plasma concentration, and half-life up to week 24. Safety and effectiveness will be monitored throughout the 54 weeks. Participants will also undergo physical exams and laboratory tests to track their health and response to the treatment.

Researchers are evaluating the safety and effectiveness of VDPHL01, an oral investigational drug, in treating female patients with Androgenetic Alopecia (AGA), a genetic condition causing hair loss due to an excessive hair follicle response to hormones. This Phase 3, multi-center, double-blind study involves adult women aged 18 to 65 with mild to moderate AGA. The study aims to assess changes in hair counts and participants' evaluation of treatment benefit after 6 months. Participants will be randomly assigned to receive either VDPHL01 extended release tablets once daily or twice daily, or a placebo tablet. The study includes 11 visits over approximately 13 months: screening, baseline (day 1), weeks 2, months 1, 2, 4, 6, 8, 10, 12, and a final visit at month 13. During the study, participants must maintain consistent hair length, style, and color, and agree to have a micro dot tattoo placed on the scalp for photography and assessment. Throughout the trial, researchers will monitor hair growth through non-vellus target area hair counts and collect participants' feedback on treatment benefits at 6 months. The study involves multiple assessments including photography of the scalp, questionnaires, and general health evaluations. Safety and efficacy data will be collected until the final visit at month 13.