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Found 6 Actively Recruiting clinical trials
Actively Recruiting
This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.
Actively Recruiting
Researchers are evaluating the safety and effects of two study medicines, PF-07275315 and PF-07264660, in adults with moderate to severe atopic dermatitis (AD). AD is a long-lasting itchy red rash caused by a skin reaction. The study seeks participants aged 18 or older who have had AD for at least six months, have not responded well to topical treatments, and are considered by their doctors to have moderate to severe AD. The study is divided into four stages. In Stage 1, participants received either PF-07275315, PF-07264660, or placebo; this stage is complete. In Stage 2, participants receive either PF-07275315 or placebo. In Stage 3, participants who previously received anti-inflammatory proteins will receive PF-07275315 or placebo. In Stage 4, participants will receive PF-07264660 or placebo. All treatments are given as multiple shots under the skin at the clinic during each stage. Placebo shots look like the study medicines but contain no active drug. Participants will be involved for up to 40 weeks (10 months) in Stages 1, 2, and 4, and up to 52 weeks (13 months) in Stage 3. Researchers will regularly assess their skin condition, measure improvements, and monitor for any side effects. The main outcome is the number of participants achieving at least 75% improvement in their eczema severity score at week 16. Participants will attend scheduled visits, lab tests, and follow study procedures throughout the study.
Actively Recruiting
Researchers are studying the effects of a drug called KAI-9531, given as a subcutaneous injection once a week, in adults living with obesity or overweight who also have type 2 diabetes. The main goal is to see if KAI-9531 is better than a placebo at reducing body weight and lowering hemoglobin A1c (HbA1c), a measure of blood sugar control, over a 76-week period. This Phase 3, randomized, double-blind, placebo-controlled trial focuses on those who have tried and struggled to lose weight through diet and exercise. Participants receive either KAI-9531 or a placebo through weekly injections under the skin. The study compares doses 3 and 4 of KAI-9531 against placebo to evaluate changes in body weight and HbA1c from the start of the study to week 76. The treatment is monitored closely throughout the trial to assess effectiveness and safety. During the study, participants will have their body weight and HbA1c measured at baseline and again at week 76 to observe changes. Researchers will also monitor safety and any side effects. The overall participation includes regular follow-ups and assessments to track progress and health status over the study duration.
Actively Recruiting
Researchers are evaluating the effects of KAI-9531, a weekly subcutaneous injection, on body weight changes in adults living with obesity or overweight who also have weight-related health conditions but do not have diabetes. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare KAI-9531 against a placebo to understand its impact on weight reduction over time. Participants will receive either KAI-9531 or a placebo as a subcutaneous injection once a week. The study focuses on the percent change in body weight from the start of treatment to week 76. Both the treatment and placebo groups will be monitored throughout the trial to assess efficacy and safety. During the study, participants will have their body weight measured at baseline and week 76 to track changes. Researchers will also monitor safety and other health factors throughout the trial. The total participation duration includes the treatment period up to week 76, with assessments to evaluate the impact of the injections on weight and related health conditions.
Actively Recruiting
Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous lunsekimig compared to a placebo in adults aged 40 to 80 years with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This Phase 2b/Phase 3, parallel, 3-arm study focuses on participants who have a history of COPD with an eosinophilic profile and have not achieved control with current treatments. Eligible participants will receive either lunsekimig or a matching placebo through subcutaneous injections over a randomized treatment period of approximately 48 weeks. The study involves three periods: an initial screening period lasting up to 4 weeks, followed by the 48-week treatment period, and finally an 8-week follow-up period. The total study duration may last up to 60 weeks. During the study, participants will be regularly assessed for the annualized rate of moderate-to-severe COPD exacerbations from baseline up to 48 weeks. Researchers will monitor safety, tolerability, and treatment effects through various evaluations throughout the treatment and follow-up periods. Participant involvement includes completing assessments and receiving scheduled injections as part of the study protocol.
Actively Recruiting
Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.