Wellesley

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.

This research aims to evaluate whether the combined use of the EXOMIND BTL-699-2 and EMSELLA HPM-6000UF devices can improve depressive symptoms, sexual function, and urinary incontinence in women who are perimenopausal or postmenopausal, aged 40 years and older, without other medical causes. The study uses a prospective, multi-center, randomized, single-blinded design with two groups to assess safety and efficacy over approximately five months. Participants are randomly assigned in a 31 ratio to either an active treatment group or a sham treatment group. The active group receives six sessions of transcranial magnetic stimulation using the BTL-699-2 device over the left dorsolateral prefrontal cortex at intensities up to 70% of their motor threshold, and six treatments with the HPM-6000UF device applied to pelvic floor muscles at intensities up to 100%. The sham group receives similar procedures at minimal intensities 1%. Treatments are spaced 3 to 7 days apart. During the study, participants complete several assessments including the Patient Health Questionnaire-9, Hamilton Depression Rating Scale, Greene Climacteric Scale, International Consultation on Incontinence Questionnaire, Female Sexual Function Index, Warwick-Edinburgh Mental Wellbeing Scale, Columbia Suicide Severity Rating Scale, Therapy Comfort Questionnaire, and Subject Satisfaction Questionnaire. These are completed at baseline, during treatment, and at follow-ups 1 month and 3 months post-treatment. Researchers monitor changes in depressive symptoms, sexual function, urinary incontinence, mental well-being, therapy comfort, satisfaction, and any treatment-related adverse events.

The Contrast-Enhanced Spectral Mammography Imaging Screening Trial CMIST aims to find out if dual-energy contrast-enhanced spectral mammography CESM can detect more breast cancers with fewer false positives than digital breast tomosynthesis DBT in women with dense breasts. The study evaluates these two imaging methods at baseline and after one year to improve breast cancer screening accuracy in women aged 45 to 74 with dense breast tissue. Participants will receive both standard DBT and CESM screenings on the same day at the start of the study and again after one year. At the two-year point, participants will return to their usual mammography screening without CESM. The study involves routine imaging procedures without additional treatments, aiming to compare the diagnostic performance of these imaging techniques. Throughout the study, participants will have baseline and one-year imaging visits, followed by a two-year follow-up contact to confirm no interval breast cancer diagnosis. Researchers will monitor cancer detection rates at baseline and recall rates at one year. Safety questions about adverse events will be asked during follow-up, and participants usual breast cancer screening care will continue after study completion.

Researchers are collecting Optical Coherence Tomography OCT data to study both normal and diseased eyes, including conditions such as retinal disease, glaucoma, and corneal disease. This observational study aims to gather detailed imaging information to better understand these eye conditions using the A10900 OCT device. Participants will undergo OCT imaging with the A10900 device, which captures detailed pictures of the eyes structures. The study includes groups with retinal disease, glaucoma, corneal disease, and healthy eyes. Each participant will have OCT scans taken to collect data relevant to their specific eye condition or normal eye status. During the study, participants will have their eyes scanned with OCT and may undergo vision tests like best-corrected visual acuity BCVA. Researchers will count the number of OCT scans performed over one year to measure outcomes. Participants will be monitored for their ability to tolerate imaging and comply with study procedures. The study includes healthy volunteers and people with various eye diseases, with ongoing safety and imaging quality assessments.

Researchers are evaluating an online intervention designed to support conversations between fathers and their high-school-aged teens about sex and relationships. This pilot study aims to assess the programs acceptability, feasibility, and early effects using Social Cognitive Theory and an Intervention Mapping approach. The study will involve 50 father-teen pairs and will help determine if a larger-scale study is justified. The intervention includes three weekly online modules delivered via Qualtrics and Zoom, featuring separate lessons for fathers and teens, joint father-teen activities, and weekly father support group sessions. Each module lasts one week and includes self-paced lessons, interactive activities, and scheduled group meetings to encourage discussion and learning. Participants will receive reminders and have access through computer or tablet. Participants will complete surveys before and after the intervention to measure changes in sexual health knowledge, communication self-efficacy, and comfort discussing these topics with family. Feasibility is tracked through enrollment, retention, lesson participation, and feedback collected via surveys and interviews. The study includes detailed assessments of program acceptability and participant experiences, with involvement lasting approximately six weeks.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of a modified dosing schedule of ublituximab for adults with relapsing multiple sclerosis RMS. This phase 3b study has three parts Part A is an open-label single-arm study, Part B is a randomized, double-blind, placebo-controlled study, and Part C is an open-label single-arm study focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The primary goal is to measure changes in T1 Gadolinium-enhancing brain lesions and drug levels in the blood. Participants receive ublituximab by intravenous infusion following different dosing regimens depending on the study part. In Part A, participants initially received infusions on Day 1 of Week 1, Day 15 if applicable, and Week 24. In Part B, participants receive either 600 mg ublituximab on Week 1 Day 1 followed by placebo on Day 15 and 450 mg ublituximab at Week 24, or 150 mg ublituximab on Day 1 followed by 450 mg on Day 15 and Week 24. Part C participants receive 150 mg on Day 1, then 450 mg on Day 15 and Week 24. Enrollment in Parts A and B has closed according to protocol updates. During the study, participants undergo regular assessments including brain imaging to track T1 Gadolinium-enhancing lesions, blood tests to measure drug levels, and evaluations for infusion-related reactions. Treatment satisfaction questionnaires are collected at baseline, Week 24, and Week 48. Safety and efficacy are monitored up to 48 weeks. The total study duration covers treatment and follow-up visits, with primary outcomes measured at Week 48 to assess changes from baseline.