Glenn Dale

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

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 real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

This research focuses on participants with Hidradenitis Suppurativa (HS) who have previously taken part in specific Incyte-sponsored clinical trials of povorcitinib. The study is a Phase 3b rollover trial designed to continue monitoring these individuals to gather further information on the treatment. It aims to evaluate the safety of povorcitinib over an extended period, including the proportion of participants experiencing treatment-emergent adverse events for up to about three years. Participants will continue taking the study drug povorcitinib orally as specified by the study protocol. This rollover study includes individuals who completed the treatment period in the parent studies without safety or tolerability issues and who showed clinical benefit from povorcitinib. During this study, participants will follow the protocol-defined dosing and procedures while avoiding pregnancy or fathering children as required. Throughout the study, participants will attend scheduled visits and assessments to monitor their health and treatment effects. Researchers will track adverse events and adherence to the treatment plan. The study involves ongoing evaluation for up to approximately three years to ensure safety and collect important long-term data on povorcitinib use in this group of patients with HS.

Researchers are evaluating the safety and effectiveness of ELLANSÉ®-S, a dermal filler, for treating nasolabial folds (NLFs) in a prospective, randomized, multi-center, split-face, controlled, double-blind clinical trial. Each of the 126 subjects will receive ELLANSÉ®-S treatment on one NLF and a control filler, Radiesse®, on the opposite side. The study includes an initial treatment, an optional touch-up at 4 weeks, and possible retreatments at 12 or 18 months if the fold returns to baseline or worsens. The trial aims to assess wrinkle severity changes and patient satisfaction over a 24-month follow-up period. Participants will be treated with sterile, pre-filled syringes containing either Ellanse S, a polycaprolactone and carboxymethylcellulose gel-based dermal filler, or a calcium hydroxylapatite and carboxymethylcellulose-based filler. Touch-ups after initial or retreatment injections are done using the same material as the initial treatment for each side. Safety visits occur at 2 weeks after each injection, with regular follow-ups scheduled at weeks 4 and 6, and months 3, 6, 9, 12, 18, and 24. Retreated subjects have additional safety visits at 3 and 6 months post-retreatment. Participants will have treatment area assessments using the Wrinkle Severity Rating Scale (WSRS) and additional scales like the Global Aesthetic Improvement Scale (GAIS) and FACE-Q questionnaires. Safety is monitored through telephone or email contacts 72 hours after injections and in-person visits. The study will last about 30 months, with all participants enrolled within 6 months after the first subject and followed for at least 24 months from initial treatment. The study includes diverse skin types and both male and female subjects.

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.

Researchers are conducting a multicenter screening study to determine how common the KIT D816V mutation is among people suspected of having clonal mast cell disease. This condition involves abnormal mast cells, and the study aims to better understand its presence in selected patient groups. The study includes participants with various related conditions such as suspected KITD816V mutated clonal mast cell disease. Participants will provide informed consent and relevant medical history before samples are collected for testing. The main intervention is screening to detect the KIT D816V mutation using advanced laboratory techniques, including digital droplet polymerase chain reaction and ultra-sensitive rolling circle amplification assays. The study includes multiple cohorts with specific inclusion criteria based on symptoms, diagnoses, or related conditions. During the study, researchers will assess the proportion of participants in cohort 1 who have the KIT D816V mutation in their blood on the first day of screening. Participants will be monitored through sample collection and medical history review. The study aims to improve understanding of the mutation's prevalence, which may guide future diagnosis and treatment approaches for clonal mast cell disease. The total duration and further follow-up details are not specified.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 study compares ruxolitinib cream to a vehicle cream, aiming to see if the treatment helps clear HS symptoms better than a non-active cream. The study focuses on participants with mild to moderate HS who have had the condition for at least six months. Participants will apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily to the affected areas. The study is double-blind and randomized, meaning neither the participants nor the researchers know who receives the active or vehicle cream during the treatment period. Participants must avoid using antibiotics or topical antiseptics on HS areas during the study and extension periods. Throughout the study, participants will be monitored to evaluate the proportion achieving a clinical response, specifically a 75% improvement in HS symptoms by week 16. Safety and treatment effects will be assessed through regular visits, and participants will be observed for any side effects or changes in their condition. The study's total duration includes the treatment and extension phases, with careful adherence to treatment application and restrictions to ensure accurate results.