Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating SAR445399 in adults with moderate to severe hidradenitis suppurativa, a chronic skin condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of two different doses of SAR445399 compared to placebo. The study is sponsored by Sanofi and involves adult participants who have had symptoms for at least six months and meet specific severity criteria. Participants will be randomly assigned to receive one of two SAR445399 dose regimens or a matching placebo. The study involves a 32-week treatment period, which is divided into a 16-week initial double-blind phase followed by a 16-week treatment-blinded extension phase. SAR445399 and placebo are given by injection. The trial includes a total of 16 visits over approximately 46 weeks. During the study, participants will undergo regular assessments to measure skin improvement, pain levels, quality of life, and safety. Researchers will monitor clinical responses using standardized scales such as the Hidradenitis Suppurativa Clinical Response HiSCR and other quality of life questionnaires. Laboratory tests, vital signs, and ECGs will also be performed. Safety will be tracked throughout the treatment and extension periods, with follow-up visits included in the 46-week study duration.
Actively Recruiting
Degenerative cervical myelopathy DCM is a common cause of spinal cord dysfunction in adults, leading to progressive problems with movement, sensation, and autonomic functions. Standardized and accurate assessment of neurological function is crucial for making clinical decisions, predicting outcomes, and comparing treatments. This study aims to create and validate a Turkish version of the Modified Japanese Orthopaedic Association mJOA score, a widely used tool that measures neurological status in DCM patients, since no validated Turkish version currently exists. The study is a prospective, cross-sectional validation involving adult patients with confirmed DCM. Researchers will culturally adapt the mJOA score into Turkish using a standardized translation process. They will review previous cervical MRI scans to assess the level of spinal cord damage and collect clinical data including age, sex, symptom duration, and treatment status. The Turkish mJOA scores will be compared with other clinical scales like the Neck Disability Index and Nurick grading system to evaluate validity. Reliability will be tested by comparing scores from two independent evaluators and by repeating the test after 7 to 14 days in stable patients. Participants will attend outpatient clinics where clinical scales and questionnaires will be administered. The study will record the time needed to complete the Turkish mJOA and note any difficulties. Researchers will analyze correlations between scores and evaluate consistency between raters and over time. The main outcomes include the Turkish mJOA score and Neck Disability Index on the first day. This research will help standardize DCM assessment in Turkish clinical practice and support international comparisons.