Cadiz

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating the efficacy and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in people with recurrent or metastatic RM HPV-negative head and neck squamous cell carcinoma HNSCC. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants who have not responded to prior anti-PD-1PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The goal is to see if adding ficlatuzumab improves survival outcomes in this patient group. Participants are assigned to one of three groups two groups receive different doses of intravenous ficlatuzumab plus cetuximab on days 1 and 15 of each 28-day cycle, while the third group receives a placebo plus cetuximab on the same schedule. The study will enroll about 410 participants and compare progression-free survival and overall survival among these groups. Treatment cycles continue until disease progression or other study endpoints. During the study, participants will undergo regular imaging scans CT or MRI to assess tumor response every 8 weeks during the first year, then every 12 weeks in years 2 and 3, and every 6 months thereafter. Researchers will monitor safety, quality of life, and immune responses, including antidrug antibodies. The study period spans approximately 44 months with ongoing evaluations from randomization until death or last response assessment.

Researchers are evaluating the study drug Corabotase IPN10200 for treating Cervical Dystonia CD in adults. This condition causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches, possibly related to brain and genetic factors. The study compares Corabotase to a placebo to assess its safety and effectiveness, aiming for a longer-lasting treatment than current botulinum toxin injections. This is a Phase II, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive one of several doses of Corabotase Dose A, Dose B, or possibly Dose C or placebo. The study drug is given by intramuscular injection into different muscles in the head, neck, and shoulders in a single treatment cycle on Day 1 of the treatment period. The study includes a screening period of up to 4 weeks followed by a 36-week treatment period with 10 in-clinic visits and one remote phone visit 12 visits for those receiving Dose C. During the study, participants will undergo physical and neurological exams, blood and urine sample collections, and clinical assessments. They will complete questionnaires to track symptoms and treatment effects. Researchers will measure changes in the Toronto Western Spasmodic Torticollis Rating Scale TWSTRS scores and other pain and disability scales at multiple time points up to week 36. Safety, antibody formation, and adverse events will also be closely monitored. Total participation lasts about 40 weeks.

Researchers are evaluating KT-621, an oral drug, for its safety and effectiveness in treating adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b randomized, double-blind, placebo-controlled trial aims to understand how KT-621 affects lung function and asthma control compared to a placebo. The study is sponsored by Kymera Therapeutics, Inc. and seeks to provide detailed information on KT-621s behavior in the body and its tolerability. Participants will be randomly assigned to one of four groups receiving different doses of KT-621 or a matching placebo. The treatment period lasts 12 weeks, during which participants take the study drug orally. The trial includes regular assessments to monitor lung function, asthma symptoms, and quality of life, with additional follow-up extending to 16 weeks to evaluate safety and drug levels in the blood. Throughout the study, participants will attend scheduled visits for lung function tests, questionnaires about asthma control and quality of life, and blood sampling to measure drug concentration and monitor safety. Researchers will track changes in lung function from the start through Week 12 and observe any adverse events up to Week 16. Participants are expected to comply with all study visits, treatments, and procedures, including keeping an electronic diary to record relevant health information.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating the pharmacokinetics how the drug moves through the body, safety, and tolerability of Vaborem, a combination of meropenem and vaborbactam, in children from birth to under 18 years old who have suspected or confirmed Gram negative infections requiring hospitalization and intravenous antibiotic treatment. This Phase 2 trial focuses on infections that may include complicated urinary tract infections, intra-abdominal infections, pneumonia, and bloodstream infections. All participants receive Vaborem intravenously every 8 hours for 10 to 14 days. After at least 3 days of Vaborem treatment, they may switch to oral antibiotics if appropriate. Pharmacokinetic samples are collected after participants have received at least 6 doses of Vaborem. This is a single-arm study where all enrolled participants receive the investigational drug. Participants will be monitored throughout their hospital stay and during scheduled follow-up visits after treatment completion. Researchers will assess drug levels in the blood on Day 3 and monitor for any adverse events up to 30 days after starting treatment. Clinical conditions and tolerability will be carefully observed to evaluate the study drugs safety and how the body processes it.

Researchers are evaluating the effectiveness of glofitamab alone compared to an investigators choice of treatments for adults with relapsed or refractory mantle cell lymphoma MCL. This phase III trial focuses on patients whose lymphoma has returned or not responded after previous treatments, including those who have received BTK inhibitors. The study aims to determine which treatment better controls the disease and improves patient outcomes. Participants in the glofitamab group will first receive two intravenous doses of obinutuzumab before starting glofitamab infusions every 21 days for up to 12 cycles. Those in the comparison group will receive either bendamustine plus rituximab for up to six 28-day cycles or rituximab combined with daily oral lenalidomide for 28-day cycles until their disease progresses. Tocilizumab may be given intravenously as needed to manage side effects like cytokine release syndrome. Throughout the study, participants will undergo regular assessments including scans to measure tumor size, blood tests, and quality of life questionnaires. The main measure is progression-free survival up to about 24 months, with additional evaluations of response rates, overall survival, symptom changes, and drug levels. Safety monitoring and long-term follow-up will occur during this period to track treatment effects and patient well-being.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.