El Paso

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis: narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatment's safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are studying the long-term safety and effects of ritlecitinib, an oral medicine, for children with severe alopecia areata, a condition that causes significant hair loss. This Phase 3 trial focuses on participants who completed previous Pfizer studies and have notable scalp hair loss or specific vaccination history. The study aims to understand how well ritlecitinib is tolerated and its impact on hair regrowth and quality of life over time. Participants will take ritlecitinib capsules once daily at home for up to three years. Those who previously received different doses of ritlecitinib will continue the same dose, while others will be randomly assigned to either a higher or lower dose. Dose adjustments and treatment continuation will be evaluated at specific months, with some participants switched to placebo if they do not meet efficacy criteria, though they remain in the study. During the trial, participants will attend 17 clinic visits and receive monthly phone calls. Researchers will monitor safety by tracking adverse events and assess effectiveness using tools like the Severity of Alopecia Tool (SALT), eyebrow and eyelash assessments, and patient-reported outcomes on anxiety, depression, behavior, and quality of life. The study includes ongoing safety checks and measures cognitive function at select points, ensuring thorough evaluation throughout the three-year participation period.

Researchers are evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with primary membranous nephropathy (PMN) who have anti-PLA2R antibodies and persistent proteinuria despite optimized RAAS inhibitor treatment. This Phase 2, open-label study aims to assess the safety, pharmacodynamics, and preliminary efficacy of this investigational drug in this patient group. Participants will receive one of three sequential intravenous dose regimens of budoprutug. Each participant will receive single IV doses on Days 1, 15, 169, and 183. Approximately 45 subjects will be enrolled across three different dose cohorts. Following treatment, participants will be monitored through Week 48, with extended follow-up for B-cell recovery as needed. Throughout the study, researchers will track safety by recording treatment-emergent adverse events up to Week 48. They will also evaluate changes in total B cell count, anti-PLA2R antibodies, proteinuria, kidney function measures (eGFR, UACR), and remission rates. Participants will have regular assessments including laboratory tests and clinical evaluations to monitor these outcomes and ensure safety.

Researchers are studying LTI-03, an experimental inhaled medication, for treating Idiopathic Pulmonary Fibrosis (IPF), a progressive and fatal lung disease characterized by lung cell death and scarring. The study aims to evaluate LTI-03's safety, side effects, impact on lung scarring, and symptom improvement. The trial includes patients diagnosed with IPF within the last five years, some of whom may be on stable doses of approved IPF treatments like nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or a placebo via a dry powder inhaler, self-administered twice daily. The study is a Phase 2, randomized, double-blind, placebo-controlled trial with a 28-day screening period, a 24-week treatment phase, and a 4-week follow-up. Approximately 120 participants will be involved, with lung scans conducted at the start and end of treatment to measure fibrosis changes. Throughout up to nine clinic visits, participants will undergo physical exams, vital sign checks, heart monitoring, blood tests, lung function tests, and lung diffusion capacity tests. They will complete questionnaires about their symptoms and safety evaluations. Researchers will monitor lung function, disease biomarkers, and side effects to assess the treatment's safety and effectiveness over the course of the study.

Researchers are evaluating petosemtamab compared with investigator's choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation linked to Alzheimer's Disease. This phase 3 trial aims to understand how these treatments impact agitation symptoms in this population. The study is sponsored by Bristol-Myers Squibb and uses rigorous methods to compare the investigational drugs against a placebo. Participants will receive either the combination of Xanomeline/Trospium Chloride capsules (KarXT + KarX-EC) or a placebo, with doses given on specified days. The study is randomized, double-blind, and placebo-controlled, ensuring objective assessment of treatment effects over a 14-week period. The trial includes a parallel group design where participants are assigned to either the experimental treatment group or placebo group. During the study, participants will be assessed for changes in agitation using the Cohen-Mansfield Agitation Inventory and other related scales at week 14. Researchers will monitor safety through adverse event reports, clinical labs, vital signs, ECGs, and specific rating scales up to week 18. Caregivers will assist by attending visits and reporting on participant status. Total participation involves regular visits and assessments over the course of the trial.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMO959 combined with lutetium (177Lu) vipivotide tetraxetan (AAA617) and an androgen receptor pathway inhibitor (ARPI) in adult men with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI treatment. This phase Ib/II study focuses on participants who may or may not have prior taxane chemotherapy exposure, aiming to explore new treatment options for this patient population. The study consists of two phases: Phase Ib includes dose escalation cohorts to establish the recommended dose of AMO959 when combined with AAA617 and ARPI (abiraterone or enzalutamide). Initially, AMO959 is given alone, then combined with AAA617. Phase II randomizes participants into three groups receiving different combinations of AMO959, AAA617, and ARPI at the recommended dose levels. Treatments are administered in cycles every six weeks for up to six cycles, with varying schedules of AMO959 and AAA617 dosing as described for each group. Participants will be closely monitored throughout the study for safety, adverse events, dose adjustments, and treatment exposure lasting up to 24 to 45 months depending on phase. Researchers will assess biochemical responses, progression-free survival, overall response, and quality of life measures. Blood samples will be collected to measure drug levels and radiation doses, and imaging scans will be used to evaluate disease progression. The total participation duration may extend up to several years with ongoing safety and efficacy evaluations.