Chambray Les Tours

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Barrett Esophagus is a condition affecting about 1.6% of people, with a risk of progression to precancerous changes known as dysplasia. This condition can lead to esophageal adenocarcinoma at a rate of about 0.5% per year. Current international recommendations support eradicating Barrett Esophagus when dysplasia or cancer in situ is present. Existing treatments, mainly thermal destruction by radiofrequency, achieve eradication of dysplasia in 81% to 100% of cases and Barrett Esophagus disappearance in 73% to 87%, usually over three sessions. However, thermal methods do not allow tissue analysis after treatment and may leave buried glands that carry a risk of cancer progression. This trial compares a new mechanical resection treatment using the EndoRotor® system to the standard radiofrequency ablation. The EndoRotor treatment involves injecting saline and adrenaline beneath the mucosa to lift it, then using a device to mechanically remove the affected tissue in one session, allowing for tissue collection and analysis. The radiofrequency method uses thermal ablation with specific probes depending on the lesion type and size, requiring multiple overlapping treatments to cover the affected area. Participants will be monitored through endoscopic check-ups at three months after treatment to evaluate the full eradication of Barrett Esophagus by absence of residual disease. The study also involves histological analysis of tissue samples from the EndoRotor procedure. The total duration and any further follow-up details beyond the three-month check are not specified, but safety and effectiveness are closely assessed during these evaluations.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the effectiveness and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in adults with recurrent or metastatic human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). This phase 3 study focuses on participants whose cancer has returned or spread and who have previously been treated with anti-PD-1/PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The main goal is to see if the combination improves progression-free survival and overall survival. Participants will be randomly assigned to one of three groups: two groups will receive different doses of ficlatuzumab plus cetuximab, and the third group will receive a placebo plus cetuximab. Treatments involve infusions of biological agents, with ficlatuzumab being a monoclonal antibody targeting hepatocyte growth factor (HGF) and cetuximab being an epidermal growth factor receptor (EGFR) antagonist. The study will enroll about 410 participants and is double-blinded, meaning neither participants nor researchers know who is receiving ficlatuzumab or placebo. During the study, participants will be monitored regularly through imaging scans (CT or MRI) to measure tumor response, along with physical exams and laboratory tests. Researchers will track overall survival from the time of randomization until death from any cause, which may take approximately 44 months. Safety assessments and compliance with study procedures will also be closely observed throughout the trial.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Researchers are evaluating the effectiveness and safety of induction therapy with Afimkibart (RO7790121) compared to a placebo in people with moderately to severely active ulcerative colitis (UC). This Phase III, multicenter, double-blind, placebo-controlled study focuses on participants aged 16 to 80 who have an established diagnosis of UC and have shown inadequate response or intolerance to previous UC treatments. Participants will receive either Afimkibart or a matching placebo. Those assigned to the Afimkibart group will get the drug first through an intravenous (IV) infusion, followed by subcutaneous (under the skin) injections. The placebo group will receive matching IV and subcutaneous treatments that do not contain the active drug. During the study, participants will be monitored for clinical remission at 12 weeks, which is the primary outcome measure. Researchers will assess safety and response through scheduled visits and evaluations. The study includes careful tracking of participants' health status and any side effects to understand the treatment's impact over the course of the trial.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the effectiveness and safety of standard chemotherapy alone or combined with INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma (PDAC) with a KRAS G12D mutation. This phase 3, randomized, double-blind study focuses on individuals who have not received prior treatment for metastatic PDAC. The goal is to understand if adding INCB161734 to chemotherapy improves outcomes in this group of patients. Participants will receive either oral INCB161734 tablets or a placebo, along with a chemotherapy regimen selected by the investigator following specific protocol requirements. The chemotherapy options are defined by the study protocol. Treatments will be administered as planned during the study period, with careful monitoring to assess their effects. Throughout the study, participants will be monitored for overall survival up to approximately three years, progression-free survival, and objective tumor response assessed up to about two years. Researchers will conduct regular evaluations including clinical assessments and imaging reviewed by blinded independent central review (BICR). Safety and efficacy data will be collected to understand the impact of the treatments over time.

Researchers are evaluating the safety and effectiveness of sacituzumab tirumotecan with or without bevacizumab compared to standard care in women with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. This phase 3 study aims to learn how well patients tolerate these treatments and whether they live longer without their cancer worsening. The study focuses on those who have already undergone second-line platinum-based chemotherapy and have specific cancer stages and types. Participants receive sacituzumab tirumotecan and may also receive bevacizumab through intravenous infusion. Before sacituzumab tirumotecan, rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash are given to help manage side effects. The study includes multiple treatment phases and compares these interventions to standard care. These treatments are administered under close medical supervision throughout the study. During the study, participants are monitored for adverse events and treatment tolerability over approximately six weeks in the first part, followed by progression-free survival tracking for up to about four years. Assessments include physical exams, performance status evaluations, and safety monitoring. Researchers also collect tumor tissue samples and conduct laboratory tests to evaluate treatment effects. The total participation time involves ongoing observation to measure safety and effectiveness outcomes.