Edmond

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

Researchers are evaluating the safety and preliminary effects of a single intradiscal injection of BRTX-100 in adults with chronic lumbar disc disease, a condition causing back and leg pain due to degeneration of spinal discs confirmed by imaging and clinical evaluation. This is a phase 2, double-blind, randomized study with controlled and blinded assessments to compare BRTX-100 against a sham procedure treatment. Participants will be randomly assigned to receive either BRTX-100, which contains specially cultured stem cells from their own bone marrow combined with platelet lysate, or a control group receiving a sham procedure with saline. Those in the treatment group will undergo bone marrow collection to prepare the BRTX-100 injection, while the control group will have bone marrow and blood collected but will not receive the active injection. The study includes a Safety Run-In phase with close monitoring of the first four treated participants before continuing the randomized phase. Follow-up visits will occur at weeks 2, 12, 26, 52, and 104 or early termination. During the study, participants will be monitored through physical exams, lab tests, and safety assessments to track any adverse effects and evaluate treatment impact. Primary safety measures will be assessed from baseline through week 104, and efficacy will be evaluated through week 52. The study aims to gather detailed information on safety and initial effectiveness while participants continue regular evaluations over two years, with careful oversight by medical monitors and a data safety board.

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy (GA), a late stage of Age-related Macular Degeneration (AMD) that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups: one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

Researchers are evaluating the safety and effectiveness of KT-621 in adults with uncontrolled moderate to severe eosinophilic asthma. This Phase 2b study aims to understand how well KT-621 treats this condition, how safe and tolerable it is, and how the drug behaves in the body. Participants have asthma that has been diagnosed for at least one year and meets specific lung function and inflammatory marker criteria. Participants will receive one of several doses of KT-621 or a placebo, all administered orally. The study is randomized, double-blind, and placebo-controlled, and includes multiple centers. The main treatment period lasts 12 weeks, during which doses are given to assess effects on lung function and asthma control. Safety and drug concentration in the blood will be monitored up to 16 weeks. During the study, participants will attend scheduled visits for lung function tests, asthma control questionnaires, and quality of life assessments. Blood samples will be collected to measure drug levels and eosinophil counts. Safety monitoring will track adverse events throughout the study period. The primary outcome is the change in lung function from baseline to Week 12. Participants must comply with the treatment plan and complete electronic diaries to record their symptoms and medication use.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

Researchers are evaluating the effectiveness of AXS-05 compared to bupropion in preventing the return of depressive symptoms in adults with major depressive disorder (MDD) who have already responded to treatment with AXS-05. This is a randomized, double-blind, active-controlled study conducted across multiple centers, aiming to assess relapse prevention in people diagnosed with MDD without psychotic features. Participants will first receive open-label AXS-05 treatment for up to 10 weeks, during which their response and remission will be monitored. Those who meet response and remission criteria will then be randomly assigned to continue taking AXS-05 or switch to bupropion tablets, both taken twice daily, for a double-blind treatment period lasting up to 26 weeks or until depressive symptoms relapse. Throughout the study, participants will be closely monitored for signs of depressive symptom relapse using regular assessments. The main outcome measured is the time from randomization to relapse over the 26-week double-blind period. The entire study period includes an initial 10-week treatment phase followed by up to 26 weeks of randomized treatment, with ongoing evaluation by the study team to track safety and treatment effects.

This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease (COPD) who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.

Researchers are evaluating the effectiveness of NBI-1065845 as an additional treatment to delay the return of depressive symptoms in adults with major depressive disorder (MDD). This Phase 3 study compares NBI-1065845 with a placebo to understand its ability to maintain symptom relief in participants who have had an inadequate response to oral antidepressants. The study is led by Neurocrine Biosciences and uses a randomized, double-blind, placebo-controlled design. Participants will first receive NBI-1065845 during an open-label treatment period. Then, they will be randomly assigned to continue either NBI-1065845 or switch to a matching placebo during a double-blind maintenance phase. The treatments are given as oral tablets, and participants will continue their existing oral antidepressants at the same dose throughout the study. Participants will be monitored from randomization to the earliest relapse or the end of the study, which can last up to about 32 months. Researchers will assess the time until depressive symptoms return using the Hamilton Depression Rating Scale. Safety and adherence to study procedures will be regularly checked to ensure participant well-being during the trial.

Researchers are evaluating CD388, a long-acting antiviral treatment, to prevent symptomatic influenza infections in adults and adolescents at higher risk for influenza complications. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well CD388 works compared to placebo, as well as its safety and tolerability. Participants are randomly assigned to receive either a single dose of 450 mg CD388 or a matching placebo, both given by three subcutaneous injections. The study is conducted across multiple centers and includes participants aged 12 years and older. The trial compares the incidence of influenza-like illness starting from 7 days after dosing up to 24 weeks later. During the study, participants undergo screening tests including rapid antigen tests for influenza and COVID-19 before dosing. Researchers monitor participants for influenza-like illness, collect blood samples at several visits to measure CD388 levels and immune responses, and record any side effects. The overall participation lasts up to about 24 weeks, during which adherence to study procedures and safety are closely followed.