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Researchers are studying ZL-1503 in a phase 11b clinical trial to assess its safety, tolerability, and how the body processes the drug. The study includes both healthy adults and adults with moderate to severe atopic dermatitis AD, a skin condition characterized by inflammation and itching. This randomized, double-blind, placebo-controlled trial aims to better understand the effects of ZL-1503 in these groups. The trial has two parts Part A involves single increasing doses of ZL-1503 given to healthy volunteers, while Part B involves multiple increasing doses given to adults with moderate to severe AD. Participants will receive either ZL-1503 or a placebo. The study monitors participants closely during dosing to evaluate how the drug is tolerated and how it behaves in the body. Participants will undergo various assessments throughout the study, including monitoring for adverse events, vital signs, laboratory tests, and electrocardiograms ECGs for up to 48 weeks after the last dose. These evaluations help researchers track safety and any potential side effects. The total participation period can last up to 48 weeks following dosing to ensure thorough observation.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are evaluating the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata, a condition causing significant hair loss. This randomized, double-blind, placebo-controlled Phase 1 study aims to better understand how FB102 works compared to a placebo in this patient group. Up to 32 participants will be randomly assigned in a 3 to 1 ratio to receive either FB102 or a matching placebo. Both treatments are given intravenously. The study will monitor participants over several weeks, assessing safety and changes in hair loss severity. Participants will be involved in the study for up to 36 weeks after their first dose. During this time, they will undergo regular evaluations including tracking treatment-related side effects and measuring changes in hair loss using the Severity of Alopecia Tool SALT score. Researchers will carefully monitor safety and treatment responses throughout the study.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide CPA, in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. IMV Inc.. Participants will be randomly assigned to one of two groups one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants health and treatment effects over time.

Researchers are evaluating whether metformin, a medication commonly used for diabetes, can be repurposed to slow kidney function decline in adults diagnosed with early-stage Autosomal Dominant Polycystic Kidney Disease ADPKD. ADPKD causes cyst growth in kidneys leading to pain, high blood pressure, chronic kidney disease, and reduced quality of life. This global Phase III randomized controlled trial aims to find effective, affordable treatments to reduce illness impact and improve life quality for ADPKD patients. Participants are randomly assigned to receive either extended-release metformin Metformin XR or a placebo, alongside standard care, for 104 weeks. The metformin dose ranges from 500 to 2000 mg daily based on individual tolerance and kidney function. The study includes a control group receiving identical placebo tablets for comparison. This design allows assessment of metformins effect on slowing disease progression. During the study, participants undergo regular monitoring including kidney function tests, assessment of kidney disease progression, quality of life questionnaires, and tracking of side effects and healthcare use over 24 months. The primary outcome is the change in estimated glomerular filtration rate eGFR. Secondary outcomes include kidney failure, mortality, medication dosing changes, and symptoms related to ADPKD. Safety and effectiveness are carefully followed throughout the trial period, which may last until 2030.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are investigating whether combining the investigational drug mevrometostat PF-06821497 with enzalutamide works better than enzalutamide alone for men with metastatic castration-sensitive prostate cancer mCSPC who have not previously received androgen receptor pathway inhibitors ARPI or chemotherapy in this setting. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to compare these treatments to understand if the combination improves outcomes for participants. Participants will be randomly assigned to one of two groups one group will receive mevrometostat 875 mg twice daily plus enzalutamide 160 mg once daily, while the other group will receive a placebo plus enzalutamide 160 mg once daily. The study includes several phases Screening, Randomization, Treatment, Safety Follow-up, and Long-Term Follow-up. Prior short-term androgen-deprivation therapy ADT of up to 3 months is allowed if there is no disease progression before starting the study. During the study, participants will have regular assessments including radiographic scans to monitor disease progression, laboratory tests, patient-reported questionnaires on pain and quality of life, and blood samples to evaluate tumor DNA and drug levels. The main measure is radiographic progression-free survival tracked for up to about 4 years. Safety outcomes and overall survival will also be monitored for several years. The total participation may last up to nearly 9 years, including long-term follow-up to understand treatment effects and safety over time.

This research aims to find out whether an early three-day oral steroid treatment called dexamethasone can improve both physical and mental recovery in children with Sydenhams chorea. Sydenhams chorea is a movement disorder caused by brain inflammation after an abnormal immune response to certain bacterial infections, affecting childrens movements, mood, and concentration. The condition commonly affects children with acute rheumatic fever, and recovery can take months. The study is a phase 3, randomized, double-blinded, placebo-controlled trial involving children in New Zealand and Australia. Participants will be randomly assigned to receive either oral dexamethasone or a placebo for three days. The dexamethasone dose is 20 mg per square meter of body surface per day, divided into three doses, with a maximum of 24 mg per day. The placebo group will take matching capsules on the same schedule. This short course treatment is being tested to see if it reduces the severity of Sydenhams chorea and its psychiatric symptoms. Children in the study will be monitored through scheduled visits on days three, seven, one month, three months, and twelve months. Researchers will assess chorea severity, relapse rates, psychiatric symptoms, hospital stay length, and treatment failure. Safety will be checked for any side effects possibly related to dexamethasone. The trial plans to recruit 80 participants, and overall involvement may last up to 12 months to track recovery and treatment effects comprehensively.