Montgomery

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

Researchers are evaluating the use of pemigatinib for adults with advanced or metastatic pancreatic cancer that has spread locally or to distant parts of the body. This study focuses on patients whose cancer has specific abnormal changes in the FGFR gene, which can promote cancer growth. The goal is to see if pemigatinib can block these abnormal genes to stop tumor growth and improve quality of life. Participants take pemigatinib orally once daily for 14 days in each 21-day cycle, continuing as long as the cancer does not worsen or side effects are manageable. During the study, patients undergo blood tests, CT andor MRI scans, and optical coherence tomography OCT. Additional scans like whole body bone scans and eye exams may be performed if needed. After treatment, patients are followed up 30 days later and then every 4 months for one year. Throughout the study, researchers assess tumor response using imaging and blood tests, including monitoring cell-free DNA to track response and resistance. They measure overall response rate up to 24 months and evaluate progression-free survival, disease control, overall survival, and side effects up to 12 months. Safety and tolerability are closely monitored, and patients overall health and treatment effects are regularly checked to understand the impact of pemigatinib.

This research aims to evaluate the safety and effectiveness of increasing doses of NNC0662-0419 for adults living with obesity. The study is a phase 2 randomized trial comparing different dosing approaches of NNC0662-0419 and semaglutide, both administered by subcutaneous injection. Participants include adults with obesity who are committed to losing at least 25% of their body weight. Participants are randomly assigned to one of four groups receiving either NNC0662-0419 or semaglutide, or their matching placebos. All treatments are given by subcutaneous injection in a dose-escalation manner, meaning doses increase over time. This allows researchers to compare the safety and response to these drugs and their placebos. Throughout the study, participants are monitored for gastrointestinal side effects from week 0 to week 39. Body weight and body mass index BMI changes are also measured from week 0 to week 32. Participants will attend regular visits for dosing, safety assessments, and evaluations of weight and related health measures. The trial is expected to last until July 2027.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

Alopecia areata AA is a chronic autoimmune condition causing hair loss on the scalp and other body areas, affecting children, adolescents, and adults of all backgrounds. This study focuses on patients aged 12 years and older who are prescribed ritlecitinib, a medication approved for severe AA. Researchers aim to understand patient and disease characteristics, treatment patterns, and outcomes with ritlecitinib in everyday clinical practice. Participants receive ritlecitinib according to approved guidelines and their doctors judgment, reflecting real-world treatment rather than a controlled trial setting. The study observes patients over time, assessing how the medication is used and its impact on AA symptoms. No placebo or control group is involved, as the study is observational. Throughout the study, patients attend regular clinic visits to monitor their condition, complete questionnaires about their experience and quality of life, and undergo assessments like the Severity of Alopecia Tool SALT score. The main measurement is the percentage change in SALT score after 24 weeks, with additional follow-ups at later weeks to evaluate ongoing effectiveness and patient satisfaction. The total study period extends to April 2028.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

This research aims to evaluate an Interactive Digital PrEP Toolkit designed to help cisgender women in Alabama and Mississippi learn about and access pre-exposure prophylaxis PrEP, a medication that prevents HIV infection. The study focuses on addressing barriers such as limited PrEP awareness, low HIV risk perception, and challenges in client-provider communication, especially in rural southeastern U.S. regions where PrEP use among women remains low. Participants will use the Digital PrEP Toolkit on a tablet during a clinic visit, which includes educational content tailored to women and information about various PrEP options, such as daily pills and injections. After using the Toolkit, participants receive a Personalized HIV Prevention Summary and discuss PrEP options with healthcare staff. Those interested can schedule a PrEP clinic appointment. Follow-up includes phone interviews at 3 months and medical record reviews at 3 and 6 months to assess PrEP uptake and persistence. Participants will be involved in a 30-minute enrollment visit including consent and baseline assessments, use of the Digital PrEP Toolkit, and follow-up interviews. Researchers will evaluate feasibility by measuring Toolkit completion rates and time, acceptability through satisfaction surveys, and preliminary efficacy by tracking PrEP initiation and knowledge changes. Medical records will be reviewed up to 6 months post-enrollment to monitor ongoing PrEP use, with total study participation lasting up to 18 months.

Researchers are studying the effects of povetacicept in adults with primary membranous nephropathy pMN, a kidney condition. This study aims to evaluate how well povetacicept works, its safety, and how well patients tolerate it compared to another treatment called tacrolimus. The trial includes adults aged 18 to 75 years and is conducted by Vertex Pharmaceuticals Incorporated. Participants will be randomly assigned to receive either one of two doses of povetacicept, which is given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The dosing for povetacicept is based on previous phase 2b results. This study follows a sequential design and is conducted in phases 2 and 3. During the study, researchers will monitor participants for clinical remission of their kidney disease at 104 weeks. They will also track safety by recording adverse events up to week 112. Participants will have scheduled visits to assess their condition and treatment response. The total study duration extends up to nearly four years, concluding in late 2028.

Researchers are evaluating two different treatments for patients with cervicogenic headaches linked to type II whiplash associated disorder, which often follows motor vehicle accidents. The study aims to compare the effects of non-thrust mobilization combined with exercise versus thrust manipulation combined with dry needling to determine if one approach works better for reducing headache and neck pain. This is a randomized clinical trial involving physical therapy techniques commonly used for these conditions. Participants will be randomly assigned to one of two groups for up to eight treatment sessions over four weeks. One group receives dry needling to the craniofacial, upper cervical, and cervicothoracic areas along with high-velocity thrust manipulation to the upper and midlower cervical and cervicothoracic spine regions. The other group receives non-thrust joint mobilization to similar spine regions, along with cranio-cervical flexion exercises, resistance exercises for the shoulder blade area, and electrothermal treatments. Throughout the study, participants will be assessed at baseline, 4 weeks, 3 months, and 6 months for changes in headache intensity using a pain rating scale. Additional measures include headache and neck pain frequency and duration, medication use, disability related to neck function, and pain catastrophizing. The study uses double-blind methods and monitors participants for up to six months to evaluate treatment effects and safety, with the total participation lasting about half a year.