Rolling Meadows

Researchers are studying how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is divided into two parts Part A includes both children and teenagers, while Part B includes only children. Initially, only teenagers who meet the study requirements can participate, with children joining after sufficient information is collected from other studies. Participants in Part A will be randomly assigned to receive either zasocitinib or a matching placebo daily for the first 16 weeks, followed by open-label zasocitinib treatment until the study ends. In Part B, all children will receive zasocitinib throughout the study. The treatment doses for children will be based on their weight, and adolescents will receive a fixed dose. The study lasts up to 4 years and 2 months, including screening, treatment, and safety follow-up periods. During the study, participants will visit the study site multiple times for assessments. Researchers will measure improvements in skin condition using tools like the Static Physicians Global Assessment and Psoriasis Area and Severity Index at Week 16 and throughout the open-label period. Safety and drug levels in the body will also be monitored. After treatment, there is a 4-week safety follow-up. Overall, participants will be involved for up to 217 weeks, including screening, treatment, and follow-up.

Researchers are evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.

Researchers are conducting an observational study to create precision external control groups using current and future data from patients with advanced or metastatic non-small cell lung cancer NSCLC. This study aims to evaluate different patient cohorts based on specific genetic mutations, PD-L1 status, and lines of therapy to better understand outcomes in this population. Participants are grouped into various cohorts depending on their treatment stage and genetic profile, including those starting first line therapy with immune checkpoint inhibitors ICI, patients with actionable EGFR or KRAS mutations, and those receiving second or later line therapies. The study collects information on patients receiving treatments such as ICI alone or in combination with chemotherapy, targeted therapies like osimertinib, and other physician-chosen regimens. During the study, participants medical data and treatment responses will be observed without intervention. Researchers will assess objective response rates, progression-free survival, overall survival, and time to next treatment across cohorts from September 2025 to April 2029. Participants will be followed over time to gather this information, with no additional treatments or procedures mandated by the study.

Researchers are evaluating the long-term safety and effectiveness of ORKA-001 in adults with moderate-to-severe plaque psoriasis who previously participated in an Oruka Therapeutics study. This open-label extension study allows participants to continue treatment and observe outcomes over an extended period. The study focuses on monitoring adverse events and psoriasis symptom control over time. Participants will receive ORKA-001 via subcutaneous injection following one of several dosing schedules once yearly at a high or low dose, twice yearly, or no drug until certain psoriasis response criteria are met. The treatment period lasts up to approximately 96 weeks, followed by a post-treatment follow-up period of about 48 weeks after the last study visit. During the study, participants will be regularly assessed for safety through monitoring treatment-emergent adverse events. Researchers will also measure psoriasis severity using tools like the Psoriasis Area Severity Index PASI and Investigators Global Assessment IGA to track symptom changes over the treatment and follow-up periods. The total study duration extends over several years to capture long-term outcomes and tolerability.

Researchers are evaluating the efficacy and safety of ORKA-001 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled phase 2 study aims to identify the best induction dosing regimen of ORKA-001 by comparing three different dose levels with a placebo. The study includes approximately 160 adult participants who have had plaque psoriasis for more than six months and meet specific severity criteria. Participants will be assigned to receive one of three doses of ORKA-001 or a placebo during the induction period, which lasts up to 28 weeks. Following this, they may enter a maintenance period lasting up to about 72 weeks, where three maintenance regimens are evaluated based on participant response. ORKA-001 and placebo are given by subcutaneous injection. After treatment, participants can opt to join an open-label extension study or enter a follow-up period of 48 weeks if they withdraw or do not join the extension. During the study, participants will undergo multiple assessments including skin evaluations using PASI and IGA scores to measure psoriasis severity and improvement. Safety will be monitored throughout the study and during follow-up by tracking adverse events. The primary outcome focuses on the proportion of participants achieving complete clearance of psoriasis at week 16. Total participation may last up to nearly two years, including screening, treatment, maintenance, and follow-up phases.

Researchers are evaluating the efficacy and safety of ORKA-002 in adults with moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blinded, placebo-controlled study aims to find the best induction dosing regimen of ORKA-002. Approximately 160 adult participants with this skin condition will take part in the Phase 2 trial. Participants will be randomly assigned to receive one of three different induction dosing regimens of ORKA-002 or a placebo. Both ORKA-002 and placebo are given by subcutaneous injection. The study includes three periods Screening, Induction, and Post-treatment Follow-up. During the study, participants will undergo assessments including evaluations of skin severity using PASI and IGA scores. Researchers will monitor treatment-emergent adverse events through Week 48. The primary outcome is the proportion of participants achieving complete clearance of psoriasis at Week 16. The total participation time includes screening, treatment, and follow-up periods to assess safety and treatment response.

Researchers are evaluating a non-invasive device designed to measure flow in cerebrospinal fluid CSF shunts in patients who already have an implanted shunt. The study focuses on hydrocephalus and aims to collect longitudinal data on shunt function using this new wireless thermal anisotropy measurement device. The study is interventional in nature but does not involve active treatment changes. Participants will wear the thermal anisotropy measurement device, which is placed on the skin over the implanted CSF shunt. This device uses a thermal actuator and temperature sensors to assess the flow through the shunt without requiring invasive procedures. The study includes a feasibility assessment cohort, and the device data acquisition is non-interventional. Participants may use the device at home or in an inpatient setting, with remote or in-person follow-up during a 30-day measurement period. During the study, researchers will monitor skin temperature and acceleration data for up to 90 days to assess device performance. Participants will be asked to communicate and document shunt symptoms in English, and verbal assent is required for minors 12 years and older. The study includes safety monitoring and follow-up to ensure data reliability and participant well-being. The total duration of participation varies depending on the setting and follow-up schedule.

Researchers are evaluating the efficacy and safety of reformulated Levulan Kerastick aminolevulinic acid HCl 20% combined with photodynamic therapy PDT for treating actinic keratosis AK lesions on the face or bald scalp. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 160 adult patients having 4 to 8 mild to moderate AK lesions. The study aims to compare different treatment approaches and incubation times to understand their effects on AK clearance and patient satisfaction. Participants will be assigned to one of four groups based on treatment typeeither the active drug Levulan or a vehicle without active ingredientand one of two incubation times before blue light therapy is applied. Up to two PDT sessions may be given depending on how the lesions respond. The study includes both drug and device interventions, specifically topical solutions and a blue light PDT device. During the study, participants will undergo multiple assessments including evaluations of lesion clearance, changes in lesion count and size, cosmetic response, and patient satisfaction at various time points up to 24 weeks. Safety will be monitored through adverse event reporting, skin reaction assessments, vital signs, and laboratory tests. The main outcome measure is the complete clearance rate of AK lesions at 12 weeks. Participants will be followed closely to assess treatment effects and safety over the study period.

Researchers are evaluating the efficacy and safety of a reformulated Levulan Kerastick solution containing aminolevulinic acid hydrochloride ALA HCl 20%, combined with photodynamic therapy PDT, for treating actinic keratosis AK lesions on the upper extremities. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study focuses on adults with 4-8 mild to moderate AK lesions on one arm. The study aims to assess complete clearance of AK lesions and other related outcomes including partial clearance, lesion count changes, recurrence, cosmetic response, and patient satisfaction. Participants will be randomly assigned to receive either the active treatment with reformulated Levulan Kerastick plus blue light PDT or a vehicle solution plus blue light PDT. Treatment involves applying the solution with occlusion and incubation followed by exposure to blue light using the BLU-U4170E device. Up to two PDT sessions may be administered depending on lesion clearance. The study includes a control group receiving the vehicle solution to compare outcomes. During the study, participants will undergo evaluations at multiple time points including weeks 4, 8, 12, 20, and 24 to assess lesion clearance, cosmetic response, and patient satisfaction. Safety monitoring includes checks for adverse events, local skin reactions, vital signs, and laboratory tests. The primary outcome, complete clearance rate, will be measured at week 12. The total study duration involves follow-up through week 24 to assess sustained effects and recurrence rates.

Researchers are evaluating participants with cancer in a non-interventional, multicenter, multicohort study to observe plasma circulating tumor DNA ctDNA biomarker changes over time. This study aims to gather valuable data alongside participants standard cancer treatments to better understand cancer biology. The study is sponsored by Tempus AI and focuses on various cancer types including KRAS mutated colorectal, pancreatic, and lung cancers, gastric cancer, metastatic prostate cancer, and others. Participants in this observational study will not receive any study interventions or treatments. Instead, they will provide blood samples at specific time points throughout their treatment journey for ctDNA analysis and other molecular studies. The study includes multiple cohorts representing different cancer types, but no additional therapies are assigned by the study team. During the study, participants will undergo regular blood draws to monitor ctDNA levels at baseline, during treatment, and after treatment for up to five years. Researchers will also generate DNA, RNA, immune, and other molecular datasets from these samples. The study involves no experimental treatments, focusing on data collection to support future cancer research. Participation may last up to five years, with ongoing monitoring of biomarker changes and data generation.