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 34 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 LatinoLatina 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 treatments 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 LTI-03, an experimental inhaled medication, for the treatment of Idiopathic Pulmonary Fibrosis IPF, a progressive and fatal lung disease characterized by lung cell death and scarring that worsens breathing over time. This Phase 2 study aims to assess LTI-03s safety, side effects, impact on lung scarring, and symptom improvement compared to placebo in patients diagnosed within the last five years. Participants may be on stable doses of other approved IPF treatments like nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or a placebo, both delivered via inhaler capsules. The study includes a 28-day screening period, followed by a 24-week treatment phase, and a 4-week follow-up. About 120 participants will self-administer the study drug twice daily. Assessments include lung function tests, lung scans, blood samples for biomarkers, and symptom questionnaires. Participants will visit the clinic up to nine times during the study for safety checks including physical exams, vital signs, heart monitoring, and blood tests. Lung function will be tested regularly, and specialized lung scans will be done at baseline and end of treatment to measure fibrosis changes. Researchers will monitor adverse events and study drug use throughout. The main outcome is safety and tolerability measured by treatment-related side effects during the 24 weeks of treatment.

Researchers are evaluating remibrutinib, a drug that inhibits Brutons tyrosine kinase BTK, to see if it can reduce inflammatory skin lesions in adults with moderate-to-severe papulopustular rosacea PPR. This Phase 2 study also assesses the safety and tolerability of remibrutinib for this condition. The study is randomized, double-blind, placebo-controlled, and conducted across multiple centers. After a screening period of up to 30 days, which may be extended by 2 weeks for washout from prior rosacea or systemic treatments, participants will be randomly assigned to receive either oral remibrutinib or a matching placebo. The treatment phase lasts 16 weeks, followed by a safety follow-up visit about 30 days after the last dose. Participants are asked to avoid other treatments targeting PPR during the study. Participants will have their facial inflammatory lesion counts measured at baseline and after 16 weeks to evaluate changes. The Investigators Global Assessment IGA of disease severity will also be recorded. Safety and tolerability will be monitored throughout treatment and during the follow-up visit. The study involves regular visits for assessments and questionnaires over the treatment period, with total participation lasting approximately 20 weeks including screening and follow-up.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to address agitation symptoms in this population by comparing the investigational drugs with a placebo. The study is sponsored by Bristol-Myers Squibb and uses established diagnostic criteria for Alzheimers Disease. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo with specified doses on designated days. The study includes a parallel group design and treatment lasts for 14 weeks. The main focus is to assess changes in agitation using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA total score. During the study, participants will undergo regular assessments including cognitive and behavioral evaluations, safety monitoring through vital signs, laboratory tests, electrocardiograms, and rating scales for movement disorders and suicidal ideation. Caregivers will be involved to help monitor participant status and medication compliance. The primary outcome is measured at Week 14, with safety follow-up extending to Week 18. Participants are expected to be engaged throughout the treatment period and follow-up assessments.

Researchers are studying a treatment approach for adult men with PSMA-positive metastatic castration resistant prostate cancer mCRPC who have previously received one androgen receptor pathway inhibitor ARPI and may or may not have had taxane chemotherapy. This phase IbII trial aims to first evaluate the safety, tolerability, and how the body processes the drug AMO959 combined with lutetium 177Lu vipivotide tetraxetan AAA617 and ARPI. Then, it will assess the preliminary effectiveness of this combination in patients who have not yet been treated with taxane chemotherapy for mCRPC. The study includes two phases Phase Ib with small groups receiving escalating doses of AMO959 alone, then combined with AAA617 and ARPI abiraterone or enzalutamide to determine the recommended dose and Phase II where participants are assigned to treatment arms receiving AMO959 with AAA617 and ARPI, AAA617 with ARPI, or other dosing regimens. Treatments involve taking AMO959 twice daily for 14 days followed by combinations with AAA617 every six weeks for up to six cycles, along with continuous ARPI therapy. Participants will undergo safety monitoring for side effects and dose adjustments during treatment lasting up to about two years. The study measures include biochemical responses like PSA levels, progression-free survival, overall response rates, and quality of life assessments. Blood samples will track drug levels and radiation doses. Follow-up continues to monitor adverse events and disease progression for up to nearly four years from treatment start, with regular visits during treatment cycles.