Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.
This study is for patients that have been diagnosed with metastatic or locally advanced unresectable solid tumors with tumor protein 53 (TP53) mutation/loss with or without brain metastasis. This study is testing an investigational drug called AO-252. "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 maximum tolerated dose (MTD), the recommended phase II does (RP2D), and the safety profile of AO-252. The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months, followed by a 12-month follow-up period.
The MOMENTOUS study will test the prospective performance of the Tempus Pulmonary Hypertension ECG model within patients with interstitial lung disease (ILD) who do not have a diagnosis of Pulmonary Hypertension. The purpose of the study is to provide information on the clinical utility of this new technology within a multicenter randomized study. The study will target approximately 1000 participants completing the study over a period of 2-3 years. Study participation will consist of 4 visits over a period of 6 months.
A 144-week clinical research study to look at how well an investigational obesity medicine works, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.
This study also includes a placebo.
This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.
The purpose of this clinical research study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of Lichen Planopilaris (LPP). The study will also look at how safe and effective brepocitinib is and will monitor the long-term safety of brepocitinib when taken for a period up to 52 weeks.
This research study will evaluate the long-term safety and effectiveness of APG777 in patients with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a previous APG777 study. The study is multicenter and double-blind, and participants will continue with the same dose and injection schedule as in their prior study. The study includes three periods: a screening visit, an extended treatment period of about 92 weeks, and a post-treatment follow-up of up to 52 weeks. Patients who met certain improvement criteria in the previous study will continue their maintenance regimen, while others will enter an open-label Escape Arm with a different dosing schedule. The study aims to determine whether long-term use of APG777 is safe and effective for patients who may benefit from continued treatment.
The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe Crohn's disease (CD). SAR441566 is a new drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. This study will also help the Sponsor to understand which dose of SAR441566 is most effective and safe in participants with moderate to severe CD. To do this, 3 different doses of SAR441566 will be tested along with a placebo. The study will last about 1 year, will include about 260 adult participants across over 26 countries.
This study is for participants that have been diagnosed with Intermediate or High-risk Primary or Secondary Myelofibrosis. This study is testing an investigational drug called Nuvisertib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the efficacy and safety of Nuvisertib. Nuvisertib is an oral PIM1 selective inhibitor. A PIM1 selective inhibitor is a drug that specifically targets and blocks the activity of the PIM-1 kinase, an enzyme implicated in cancer cell growth. This drug is given to participants by mouth. Participants in this study can expect to be in the treatment phase of this study for 19 months and the long term follow up phase for 3 years.