Middleton, Wisconsin

Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Amnio-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of these visits will be recorded. Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure. Additionally, pain and safety will be assessed as secondary endpoints.

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

LUNAR-2 is a pivotal, randomized, open-label study that aims to evaluate the effectiveness and safety of Tumor Treating Fields (TTFields) concomitantly administered with pembrolizumab and platinum-based chemotherapy for the treatment of metastatic non-small cell lung cancer (NSCLC). The primary objectives of the study are to assess overall survival (OS) and progression-free survival (PFS) in subjects treated with TTFields, pembrolizumab, and platinum-based chemotherapy compared to those treated with pembrolizumab and platinum-based chemotherapy alone. PFS will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The secondary endpoints of this study will evaluate PFS and OS, stratified by the specific histological subtype of NSCLC and PD-L1 Tumor Proportion Score (TPS). The population will consist of subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and will be stratified as follow: 1. Histology - Squamous vs. non-squamous 2. PD-L1 expression level - TPS <1% vs. TPS 1-49% vs. TPS ≥50% 3. Prior treatment with immunotherapy - yes vs. no The study will be conducted globally at approximately 130 participating sites. The study device, NovoTTF-200T, is a portable, battery-operated system that delivers TTFields at a frequency of 150kHz. It utilizes insulated transducer arrays to deliver electric forces intended to disrupt cancer cell division.

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib. All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study: - If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib. If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib. - All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib. - If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued. - RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study. The treatment duration per participant will be approximately 3 years of OL tolebrutinib.

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations. Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.

A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)

A Study of LP-300 with Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma

Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs) will be eligible for enrollment. The trial will proceed in two stages. In the safety lead-in stage, 6 patients will be enrolled and treated with the LP-300 co-administered in combination with carboplatin and pemetrexed. In the absence of any safety signals in these patients, the second stage of the trial protocol will begin. This second stage consists of randomizing patients in a 2:1 allocation ratio to one of two arms: investigational arm of carboplatin, pemetrexed, and LP-300 or the standard of care arm of carboplatin and pemetrexed. Treatment of both groups will be on Day 1 of a 21-day cycle. A total of 4 to 6 treatment cycles are planned (number of cycles determined by PI discretion), with the possibility of patients going into a pemetrexed maintenance phase afterwards.

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

A Study of SGN-B6A in Advanced Solid Tumors