The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.
Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.
Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.
An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.
Adolescence is a time of development in the brain and microbiome, including the microbiome present in the mouth called the oral microbiome. Alcohol use often begins and escalates during adolescence, which can cause changes to the oral microbiome leading to changes in the brain. The alcohol specific changes to the oral microbiome and the brain may make adolescents more vulnerable to a lifelong struggle with alcohol use disorder. This study will collect (1) saliva to assess the composition of the oral microbiome and (2) brain measurements using magnetic resonance imaging (MRI) across adolescents who may or may not use alcohol. Findings from this study will help form a more thorough understanding of the biological consequences of adolescent alcohol use, with the long-term goal of informing novel prevention and intervention efforts.
This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.
Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.
If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.
This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.
This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.
This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well Petosemtamab works at curing this type of cancer. The study results may be used to help others in the future.
This research study is being done to see the long term effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. You could be eligible to participate in the study if you completed the first double blind study successfully and your study doctor see's that you meet all the criteria for this study.
This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.
This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.