Saint Joseph

Researchers are evaluating VENT-03 in adults with active cutaneous lupus erythematosus CLE, including those who may also have systemic lupus erythematosus SLE. This Phase 2a clinical trial aims to determine if VENT-03 affects the activity and severity of CLE and to assess its safety and how the body processes the drug. Participants will be compared to a placebo group to better understand VENT-03s effects. Participants will take either VENT-03 tablets or a placebo for the first 4 weeks. After this double-blind phase, all participants switch to taking VENT-03 for an additional 8 weeks in an open-label extension. The study uses a randomized, double-blind design with monthly clinic visits for checkups and tests throughout the treatment periods. During the study, participants will visit the clinic once a month for assessments including physical exams and tests to monitor the drugs effects and safety. Researchers will evaluate changes in interferon gene signature in the skin, CLE disease severity, skin biopsy markers, and record any treatment-emergent adverse events. Blood samples will be collected to study the drugs concentration over time. The total treatment duration is 12 weeks with ongoing safety and efficacy monitoring.

Researchers are evaluating the effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.

This research aims to evaluate the effectiveness and safety of upadacitinib at different doses for adults with moderate to severe atopic dermatitis AD who have not responded well to dupilumab treatment. AD is a skin condition causing rash and itching due to inflammation. The study includes approximately 200 adults aged 18 to less than 64 years, all current dupilumab users with a history of inadequate response. The trial is conducted in two periods to compare upadacitinib 15mg to dupilumab 300mg and adjust doses based on clinical response. In Period 1, participants are randomly assigned to receive either upadacitinib 15mg tablets once daily or dupilumab 300mg subcutaneous injections every two weeks for eight weeks. Participants on upadacitinib 15mg may have their dose increased to 30mg after two weeks depending on response. Period 2 lasts 24 weeks, during which participants continue or adjust doses based on their Eczema Area and Severity Index EASI response at Week 8. Participants may remain on their assigned dose or switch doses accordingly. Participants attend regular visits at hospitals or clinics during the 35-day screening, 8-week Period 1, and 24-week Period 2, plus a 30-day follow-up. Assessments include medical exams, blood tests, monitoring for side effects, and questionnaires. Researchers measure outcomes such as the percentage achieving at least a 90% reduction in eczema severity EASI 90 at Week 8. The study monitors treatment effects and safety carefully throughout the 32-week treatment and follow-up period.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

This research aims to evaluate the effectiveness and safety of plixorafenib in participants with cancers that have specific BRAF gene alterations. These include locally advanced or metastatic solid tumors, primary central nervous system tumors, and rare BRAF V600E-mutated solid tumors such as anaplastic thyroid, ovarian, and cholangiocarcinoma cancers. The study focuses on participants with BRAF V600E mutations or BRAF fusions and seeks to understand treatment effects across various cancer types. Participants receive plixorafenib orally in continuous 3-week cycles. Dosing may be increased as tolerated and continues until disease progression, unacceptable side effects, or withdrawal for other reasons. The study includes different subprotocols tailored to tumor type and BRAF alteration, such as unresectable solid tumors with BRAF fusions, recurrent primary CNS tumors with BRAF V600E mutations, rare non-CNS solid tumors with BRAF V600E mutations, and other advanced solid tumors with BRAF V600E mutations. Participants will undergo scans before starting treatment to assess tumor changes, and regular monitoring will continue during treatment. Researchers will evaluate tumor response, progression-free survival, overall survival, treatment safety, and drug levels in the blood over up to approximately four years. The study tracks side effects and collects detailed pharmacokinetic data to understand how the drug is processed. Participants remain in the study until disease progression or other withdrawal criteria are met, with ongoing safety and efficacy assessments.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years who have nonsegmental vitiligo. The study focuses on pediatric participants with depigmented areas of skin caused by this condition and seeks to better understand how the cream may impact these areas. Participants will be randomly assigned to receive either ruxolitinib 1.5% cream or a matching vehicle cream. Both creams are applied topically as a thin film twice daily to the affected skin areas according to the study protocol. The trial includes a 24-week treatment period during which improvements in skin pigmentation and safety outcomes are monitored. During the study, children will have regular assessments including evaluations of the affected skin areas using the Facial Vitiligo Area Scoring Index and Total Body Vitiligo Area Scoring Index. Safety is monitored through reports of any side effects and laboratory tests at various timepoints up to 52 weeks. Participants are followed closely for adherence to treatment and overall health throughout the study duration.

Researchers are evaluating the pharmacokinetics and safety of Dupilumab in children and adolescents aged 6 months to less than 18 years with prurigo nodularis, a chronic skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to better understand how Dupilumab behaves in the body and its safety profile in this young population. Participants will receive Dupilumab administered by subcutaneous injection, with dosing based on their weight and age. The study includes three periods a screening period lasting 2 to 4 weeks, a treatment period of 24 weeks during which Dupilumab is given, and a post-intervention follow-up period of 16 weeks. Each participant will have a total of 6 planned study visits over approximately 42 to 44 weeks. Throughout the study, participants will complete daily symptom diaries and undergo evaluations to measure Dupilumab concentration in the blood from Day 1 to Week 40. The study will also monitor any treatment-emergent or serious adverse events and check for the development of antibodies against Dupilumab. Safety and effectiveness assessments will continue during the follow-up period to ensure comprehensive monitoring of participant health and treatment response.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.