Rolling Meadows

Researchers are evaluating the effects, safety, and response to the medicine zasocitinib in children and teenagers aged 4 to under 18 years who have moderate-to-severe plaque psoriasis. The study is designed in two parts, with Part A including both children and teenagers and Part B including only children. Initially, only teenagers meeting the study criteria can join, with children joining later after more data is collected from other studies. In Part A, participants are randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all receive zasocitinib for the rest of the study. Participants in Part B receive zasocitinib throughout. The treatment period lasts up to 208 weeks, followed by a 4-week safety follow-up. Both drug and matching placebo are used, and the study is conducted at multiple centers. Participants will attend multiple visits to the study site over a total duration of up to 4 years and 2 months, including a screening period of up to 35 days. Researchers will assess improvements in psoriasis severity using measures like the Static Physician's Global Assessment and Psoriasis Area and Severity Index at week 16. In Part B, they will also study how the body absorbs and processes zasocitinib by measuring drug levels at specific times. Safety and tolerability will be monitored throughout the study.

Researchers are evaluating patients with advanced or metastatic non-small cell lung cancer (NSCLC) to create control arms using current and future treatment information. This prospective study aims to generate precise external controls for patients receiving therapies recommended by the National Comprehensive Cancer Network (NCCN). The focus is on patients treated in second or third line with NCCN-approved systemic therapies. Participants must have pathologically confirmed NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status greater than 1, indicating they are fit for further systemic therapy. Eligible patients are those starting or within 14 days of starting second line therapy according to NCCN guidelines. The study monitors patients over time to assess treatment responses and outcomes. During the study, researchers assess the objective response rate (ORR) by patient cohort from September 2025 to April 2029. Participants are followed closely with imaging and clinical evaluations to ensure compliance with study protocols. Safety and life expectancy of more than three months are considered to support ongoing participation and data collection.

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

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 efficacy and safety of different dose regimens of IMG-007 compared to placebo in adult participants with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will last up to 52 weeks and aims to find the best dosing strategy for this condition. Participants will receive either IMG-007 or a placebo by subcutaneous injection. The study involves multiple dose regimens to assess how well IMG-007 works and how safe it is. Participants will be randomly assigned to one of the treatment groups, and both participants and researchers will be unaware of the treatment assignment to ensure unbiased results. During the study, participants will be monitored regularly with assessments including the Eczema Area and Severity Index (EASI) to measure skin condition changes, focusing on the mean percent change from baseline at Week 20. Safety will also be closely tracked throughout the study. The total participation period may extend up to 52 weeks, allowing for thorough evaluation of treatment effects and safety over time.

Researchers are conducting a multicenter, randomized, double-blinded, placebo-controlled Phase 2 study to evaluate the safety and effectiveness of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study aims to find the best induction dosing regimen of ORKA-001 by comparing three different dosing schedules to placebo. Participants in this study have a diagnosis of plaque psoriasis lasting more than 6 months and meet specific severity criteria. The study involves four periods: a screening phase lasting up to 6 weeks; an induction period up to 28 weeks where participants receive one of three ORKA-001 dosing regimens or placebo via subcutaneous injection; a maintenance phase lasting about 72 weeks from week 28 to week 100; and a post-treatment follow-up phase. After the end of treatment or if a participant withdraws, they may choose to enter an open-label extension study or be followed for 48 weeks. During the study, participants will have regular assessments to measure the proportion achieving complete clearance of psoriasis symptoms by week 16, using the PASI score. Safety and other clinical evaluations will also be monitored throughout the study and follow-up periods to track treatment effects and participant health over time.

Researchers are evaluating a device designed to non-invasively measure the flow in cerebrospinal fluid (CSF) shunts. This study involves patients with existing implanted ventricular CSF shunts, whether functional or non-functional, including various types of distal catheters. The goal is to collect continuous data over time to better understand shunt flow dynamics in individuals with hydrocephalus. The study uses a wireless thermal anisotropy measurement device, a sensor placed on the skin over the implanted shunt. This device contains a thermal actuator and temperature sensors to assess the flow through the shunt. Participants will wear the device either at home or in an inpatient hospital setting, depending on their situation, over a 30-day measurement period. The device allows for remote and in-person follow-up during this time. Participants will be monitored for up to 90 days, during which skin temperature and acceleration data will be collected. Subjects or their caregivers must communicate clearly in English and document shunt symptoms. The study includes signed consent and, for minors aged 12 and older, verbal assent. Researchers will track safety and device performance throughout the study period, aiming to gather reliable longitudinal data on CSF shunt flow.

Researchers are evaluating the effectiveness and safety of a reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl 20%) combined with photodynamic therapy (PDT) for treating actinic keratosis (AK) on the face or bald scalp. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 160 adults with 4 to 8 mild to moderate AK lesions. The study aims to compare different treatment methods and incubation times, measuring outcomes such as complete clearance rate at 12 weeks, partial clearance, lesion count changes, recurrence, cosmetic response, and patient satisfaction, while monitoring safety through adverse events and lab tests. Participants will be randomly assigned to one of four groups based on treatment type (active drug or vehicle) and incubation time. The treatment involves using a topical solution of reformulated Levulan Kerastick or a vehicle without the active ingredient, combined with up to two PDT sessions using the BLU-U4170E blue light illuminator, depending on lesion clearance. The treatment area is limited to either the face or bald scalp, not both. Throughout the study, participants will be evaluated for lesion clearance at week 12 and monitored for safety by recording local skin reactions, vital signs, and laboratory tests. The study includes adherence to skincare routines, avoidance of sunbathing or tanning devices, and stopping topical products near clinic visits. The total study duration includes initial treatment and follow-up assessments to evaluate treatment effectiveness and safety.

Researchers are evaluating the safety and effectiveness of a reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for treating actinic keratosis (AK) on the upper arms. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 260 adults who have 4 to 8 mild to moderate AK lesions on one arm. The study aims to compare the active treatment to a placebo vehicle control, with the main goal of measuring the complete clearance of all AK lesions by Week 12. Participants will receive either the active Levulan Kerastick solution or a vehicle solution applied topically to the treatment area on one arm, followed by exposure to blue light using a BLU-U4170E device. Depending on how well the lesions clear, up to two photodynamic therapy sessions may be given during the study. The treatments focus on the extensor surface of a single upper extremity, covering about 25 cm8. Throughout the study, patients will undergo evaluations including lesion clearance rates, changes in lesion count and area, recurrence, cosmetic responses, and satisfaction. Safety will be monitored through adverse event reporting, local skin reactions, vital signs, and laboratory tests. The study period includes screening, treatment sessions, and follow-up to measure outcomes at Week 12.

Researchers are evaluating a non-interventional study that includes multiple centers and cohorts, focusing on people diagnosed with cancer. The study aims to collect and analyze blood samples over time to profile circulating tumor DNA (ctDNA) biomarkers alongside the participants' standard cancer treatments. This approach helps to observe how ctDNA levels change during and after treatment. Participants will undergo regular blood sample collection at specific times throughout the study to monitor ctDNA biomarkers. There is no experimental treatment given as part of this study; instead, the study observes changes in ctDNA in addition to the usual care provided by their healthcare team. This design allows researchers to gather important data while participants continue their standard cancer therapies. Throughout the study, participants will provide blood samples at baseline, during treatment, and after treatment for up to five years. Researchers will analyze these samples to track changes in ctDNA over time. The study focuses on measuring these biomarker changes to enhance understanding of cancer progression and treatment response. Participants' safety and standard care are maintained, and no additional interventions are required beyond blood sample collection.