Rocklin

Researchers are evaluating the safety and effectiveness of BFB759, a human monoclonal antibody that blocks multiple pro-inflammatory cytokines involved in atopic dermatitis. This phase 2, double-blind, placebo-controlled study focuses on adults with moderate to severe atopic dermatitis that has not responded adequately to topical treatments. Participants are observed over approximately 36 to 40 weeks to compare BFB759 with a placebo. Participants are randomly assigned to receive either BFB759 or a placebo, with dosing aimed at assessing different levels of the drug's effects. The study is designed as a parallel-arm trial, meaning groups receive different treatments simultaneously without crossover. The investigational drug targets key inflammatory pathways believed to drive symptoms in atopic dermatitis. During the study, participants attend regular visits for monitoring and assessments. Researchers evaluate the drug's efficacy at 16 and 32 weeks using specific outcome measures. Safety is closely monitored throughout the treatment period. Participants are also expected to follow study instructions, avoid certain medications, and complete all scheduled visits during the study duration.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating the effectiveness of remibrutinib compared to dupilumab in adults with moderate to severe chronic spontaneous urticaria (CSU) that is not adequately controlled by second generation H1-antihistamines (sgH1-AHs). This Phase 3b, multi-center, randomized, double-blind, double-dummy study is conducted in the US and focuses on early treatment effects at 4 weeks and earlier. The study includes a screening period of up to 4 weeks, followed by a 12-week core treatment period where about 400 participants are randomly assigned to receive either remibrutinib (25 mg twice daily by mouth) with a placebo injection or dupilumab (a 600 mg loading dose followed by 300 mg every 2 weeks by injection) with a placebo tablet. All participants continue their stable dose of sgH1-AH during this period, with the option to add rescue doses if needed, not exceeding four times the standard dose per day. After the core period, participants may join an optional open-label extension to receive remibrutinib for an additional 12 weeks if the drug is not commercially available. Participants will complete daily diaries and regular assessments to track urticaria symptoms and treatment effects. Researchers will measure changes in the Weekly Urticaria Activity Score (UAS7) from the start to Week 4. Safety follow-up will occur for 12 weeks after treatment ends, with phone calls and site visits as needed, continuing longer if participants join the extension. The total study duration includes screening, treatment, optional extension, and safety follow-up phases.

This research aims to evaluate the safety and effectiveness of ruxolitinib cream in children aged 2 to 11 years with nonsegmental vitiligo, a condition that causes loss of skin color in patches. The study is a Phase 3 trial focusing on this pediatric population to better understand how well the treatment works and how safe it is for young patients. Participants will be randomly assigned to receive either ruxolitinib cream or a matching vehicle cream, both applied as a thin layer twice daily to the affected skin areas. The treatment is topical and focuses on areas of skin depigmentation, including the face and other body parts. The study measures progress over 24 weeks to determine the proportion of participants who achieve significant improvement in facial vitiligo. Throughout the study, participants will have regular assessments including skin evaluations and safety monitoring. Researchers will track changes in the affected skin areas using the Facial Vitiligo Area Scoring Index. Participants must stop all other vitiligo treatments before starting and during the study. Safety follow-ups will continue after treatment to ensure participant well-being and gather comprehensive data on treatment effects.

Researchers are studying how well lebrikizumab works for adolescents and adults with moderate atopic dermatitis (eczema) who have a high level of itchiness and limited areas affected on the body. The study focuses on participants who have had eczema for at least one year and aims to measure improvements in skin condition and itch severity. This is a Phase 4, open-label, single-arm trial involving individuals aged 12 and older. Participants will receive lebrikizumab through subcutaneous injections. The treatment period lasts for 24 weeks (6 months), during which the medication is administered as per the study protocol. The entire participation, including screening and follow-up, spans approximately 38 weeks (9 and a half months). During the study, participants will undergo regular assessments including skin evaluations and itch severity ratings to track changes from baseline. Researchers will measure the percentage of participants achieving at least a 75% improvement in eczema severity or a 4-point reduction in itch intensity by week 16. Safety and adherence to treatment will also be monitored throughout the study duration.

Researchers are evaluating the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating how well carboplatin chemotherapy works before surgery in men with high-risk prostate cancer who have inherited mutations in the BRCA1 or BRCA2 genes. This phase II trial aims to see if carboplatin can shrink tumors and lead to complete removal of cancer cells at the time of prostatectomy. The study also monitors progression-free survival, metastasis-free survival, overall survival, and treatment side effects. Additionally, specimens are collected for future research. Participants receive carboplatin intravenously before undergoing prostate surgery. If prostate-specific antigen (PSA) levels rise after surgery, patients undergo imaging tests such as CT, MRI, chest X-ray, or PSMA PET scans to monitor for cancer spread. Blood samples are collected throughout the trial to support further study and evaluation. During the study, participants have physical exams, medical history assessments, and laboratory tests including blood counts and liver and kidney function within 28 days before enrollment. Researchers track PSA progression and survival outcomes for up to five years after treatment. The trial includes regular imaging and safety monitoring to assess treatment effects and disease status over time.