Prosper

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC) in this 26-week phase 3 study. The study is randomized, double-blind, and placebo-controlled, involving multiple centers. It aims to compare three doses of tenapanor (5 mg, 25 mg, and 50 mg taken twice daily) against a placebo, with a focus on improving spontaneous bowel movements. Participants will first undergo a 2-week screening where their eligibility is assessed through medical history, physical exams, lab tests, ECG, and self-reported constipation symptoms using an electronic diary (eDiary). Eligible patients will then be randomly assigned to receive one of the three doses of tenapanor or placebo twice daily for 26 weeks. During this treatment period, patients will continue daily and weekly symptom reporting via the eDiary and attend regular safety visits at weeks 2, 4, 8, 12, 16, 20, and 26. After completing the 26-week treatment, patients enter a 4-week treatment-free safety follow-up period to monitor any adverse events. A final visit occurs at the end of this follow-up to assess safety. The main outcome measured is the durable complete spontaneous bowel movements response over 12 weeks. Overall, the study involves careful monitoring of symptoms, safety, and treatment effects over approximately 32 weeks.

This research aims to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa, a chronic inflammatory skin condition. The study is a Phase 2 and Phase 3, dose-ranging, randomized, double-blind, placebo-controlled trial comparing BFB759, a biological treatment that blocks multiple pro-inflammatory cytokines, to a placebo. Participants have had hidradenitis suppurativa for at least one year and have disease that is not well controlled by antibiotics. Participants receive either BFB759 or a placebo in a blinded manner over the course of the study. The study lasts approximately 36 to 40 weeks during which the treatment's effects and safety are assessed. The trial evaluates the drug's impact on hidradenitis suppurativa symptoms and monitors for any adverse reactions. Throughout the study, participants attend regular visits to assess their condition and safety. Researchers monitor the efficacy of BFB759 from the start to Week 16 and Week 32. Participants are asked to follow study instructions carefully, attend scheduled visits, and avoid certain other medications. The trial includes adults aged 18 to 75 years and collects data on treatment effectiveness and safety over the full study period.

Researchers are conducting a Phase 3, double-blind, placebo-controlled study to evaluate the effectiveness and safety of AXS-14 (Esreboxetine) in treating fibromyalgia. The study aims to understand how well AXS-14 manages fibromyalgia symptoms and maintains therapeutic response over time. The study includes a 12-week open-label treatment period where all participants receive AXS-14 tablets once daily. Participants who respond to this treatment are then randomly assigned in a 1:1 ratio to either continue taking AXS-14 or switch to placebo tablets once daily for another 12 weeks. This randomized withdrawal period continues until 12 weeks or until a loss of therapeutic response occurs. Participants will be involved in the study for at least 24 weeks, including both treatment phases. Researchers will monitor the time from randomization to loss of therapeutic response as the primary outcome. Assessments will include safety evaluations and adherence to medication, with regular follow-ups to track symptom management and treatment effects throughout the study.

Researchers are evaluating the clinical benefits of using hereditary cancer genomic diagnostics in individuals aged 65 years or older to assess their overall genetic cancer risk profile. This study aims to help guide physicians in pursuing preventive measures that may lead to early detection and treatment of cancer. The evaluation focuses on the use of diagnostic hereditary cancer testing ordered based on medical necessity rather than screening. Participants undergo hereditary cancer genomic testing through a buccal swab, examining a variety of genes linked to cancer risk including ATM, BRCA1, BRCA2, and others. The specific genes tested may be updated over time as new knowledge emerges. This is a non-interventional study where the testing is ordered and performed according to individual care considerations, independent of the study protocol. Data collection occurs retrospectively over an observation period of 120 to 150 days using a single case report form. Researchers will record genetic test results, physician-recommended treatments, brief medical histories, demographic data, and investigator specialty. The primary outcome is the evaluation of genomic cancer screening within 120 days. An interim analysis will determine if data collection needs adjustment to meet study objectives.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.

Researchers are evaluating the effectiveness and safety of ruxolitinib cream in people with hidradenitis suppurativa (HS), a chronic skin condition. This Phase 3 trial focuses on participants with mild to moderate HS who have had the condition for at least six months. The study aims to see how well the cream works in reducing HS symptoms compared to a placebo cream (vehicle cream). Participants will be randomly assigned to apply either ruxolitinib cream or a matching vehicle cream as a thin layer twice daily on affected areas. The study specifically includes those with a certain number of abscesses and nodules but no draining tunnels, affecting at least two different body areas. The study also requires participants to avoid using antibiotics or antiseptic products on affected areas during the vehicle-controlled period and part of an extension phase. During the study, researchers will monitor participants closely through assessments of the skin condition and safety checks. They will measure the proportion of participants who achieve a significant clinical response by week 16. The total body surface area treated must not exceed 20%, and participants will be followed to ensure adherence and safety throughout the trial period.

Researchers are conducting a Phase 2, multi-center study to evaluate the effects of tibulizumab in adults with hidradenitis suppurativa (HS), a chronic skin condition. The study aims to assess the efficacy, safety, and tolerability of tibulizumab compared to a placebo. Participants will have a history of HS with specific skin lesions and inflammation. The study includes two periods lasting a total of 32 weeks. During the first 16 weeks (Period 1), participants will be randomly assigned to receive either one of two doses of tibulizumab or a placebo under double-blind conditions. After this, all participants will enter a 16-week open-label extension (Period 2) where they will receive tibulizumab. Tibulizumab is an antibody targeting BAFF and IL-17 pathways. Participants will be involved in regular assessments including counting abscesses and inflammatory nodules, with the primary outcome measured as the percent change from baseline at 16 weeks. Safety, tolerability, and other evaluations will be monitored throughout both periods. The total participation duration may extend beyond 32 weeks including follow-up and safety monitoring.