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.
The study aims to evaluate if an experimental drug called SAR441566 can improve signs and symptoms of moderate to severe ulcerative colitis (UC). 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 UC. 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 phase III trial compares the effectiveness of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Participants will be separated into two groups, or randomized (like flipping a coin). The first group of participants will receive high dose chemotherapy followed by an autologous stem cell transplant. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. The second group will be observed by the study doctor and study team with check-ins every six months for 12 years after joining the trial. The group of participants who receive a stem cell transplant will also be checked by their doctor and study team for every 6 months for 12 years after joining the study. The main risks of the study treatment include reduced blood cell counts, nausea and vomiting, and damage to other organs (due to high dose chemotherapy).
This study is testing whether adding a new drug, casdatifan, to cabozantinib works better than cabozantinib alone in adults with advanced kidney cancer (clear cell renal cell carcinoma) that has gotten worse after previous immunotherapy. It will compare the two treatments in patients around the world to see which is more effective. A total of 8 patients will be enrolled locally over the course of 26 months, and participants may be in the study for up to five years. Before joining, patients will complete a screening process with tests and assessments to determine eligibility. If eligible, participants will be randomly assigned to one of two groups: casdatifan plus cabozantinib or placebo plus cabozantinib. There is a 2 in 3 chance of being in the casdatifan group and a 1 in 3 chance of being in the placebo group. Both drugs are taken by mouth in pill form each day. During the study, patients will have assessments such as blood tests, imaging scans, heart monitoring, physical exams, biopsies, questionnaires, and a drug diary. Participants will visit the study site two times each 28-day cycle for the first two cycles, then once per cycle thereafter. The most important risks include low blood counts, low oxygen levels, fatigue, gastrointestinal problems, skin reactions, high blood pressure, weight loss, voice changes, and bleeding.
The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.
The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.
The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.
The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.
The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.
Zasocitinib (TAK-279) is an oral TYK2 inhibitor being studied as a potential treatment for moderate-to-severe plaque psoriasis in children and adolescents, a group with limited safe and effective oral options. TYK2 plays a crucial role in immune pathways involved in psoriasis, especially through IL-23's activation of Th17 cells and production of proinflammatory cytokines. Current treatments include injectable biologics and the oral agent apremilast, but few oral therapies match the efficacy of biologics. In phase 2b trials, zasocitinib showed promising results, with over two-thirds of adult participants achieving PASI-75 at certain doses by week 12 and no major safety concerns. Ongoing phase 3 trials are evaluating zasocitinib as a potential new oral treatment for pediatric plaque psoriasis.