Seattle

Researchers are evaluating the effectiveness of tinidazole for treating Mycoplasma genitalium infection in men diagnosed with non-gonococcal urethritis (NGU) at a sexual health clinic in Seattle. Tinidazole is already FDA-approved for other infections but has not been thoroughly tested against M. genitalium. This Phase 2 study aims to estimate how well tinidazole cures this infection in this specific patient group. Men diagnosed with NGU who test positive for M. genitalium will first receive doxycycline treatment for 7 days before enrollment. After joining the study, participants will take tinidazole starting with 2 grams orally on the first day, followed by 500 mg twice daily from days 2 through 10. Urine samples collected before and after treatment will be analyzed to assess bacterial load and drug sensitivity. Participants will be monitored with a test of cure 21 days after completing tinidazole to confirm eradication of the infection. Researchers will use urine specimens to measure microbiologic cure on day 38. The study requires participants to be able to provide informed consent, complete follow-up testing, and attend the Seattle clinic. Safety and treatment effects will be closely observed throughout the study period.

Researchers are evaluating (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor-positive (ER+) and HER2-negative breast cancer. This phase 2 open-label study includes two parts: a pharmacokinetic (PK) phase to understand how the body processes the drug and a treatment phase to assess the drug's effects on tumor growth. The study aims to see if (Z)-endoxifen can slow or stop tumor growth by measuring changes in a biomarker called Ki-67. Participants are premenopausal women who meet specific cancer and health criteria. Participants in the PK part will take (Z)-endoxifen capsules daily at varying doses (20 mg, 40 mg, or 80 mg). Some will also receive a monthly injection of goserelin, a drug that temporarily stops estrogen production in the ovaries. The treatment cohort will receive both (Z)-endoxifen and goserelin. Tumor tissue samples will be collected by breast biopsy after about 4 weeks to assess the Ki-67 biomarker. Participants showing tumor response may continue treatment for up to 24 weeks or until they undergo surgery. Throughout the study, participants will have blood draws to measure drug levels and tumor markers, breast biopsies, imaging scans, and safety assessments. The main outcomes include measuring (Z)-endoxifen levels after 4 weeks, the rate of Ki-67 reduction, and tumor response after 24 weeks. Study participation lasts up to 6 months, including treatment, surgery, and a follow-up visit one month after surgery.

Researchers are evaluating the side effects and optimal dose of a radioactive drug called 211^astatine-BC8-B10 before donor stem cell transplant in adults with high-risk blood cancers including acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. This phase I/II trial studies how this radioactive antibody treatment targets cancer cells while sparing healthy cells prior to transplant. The study focuses on patients needing donor stem cell transplantation to treat their high-risk leukemia or related disorders. Participants receive the 211^astatine-BC8-B10 treatment intravenously over 6-8 hours about one week before their transplant. Some patients may also receive an additional radioactive antibody, 131^I-BC8-B10, and fludarabine phosphate chemotherapy before undergoing total-body irradiation and peripheral blood stem cell transplant on day 0. After transplant, patients take cyclosporine and mycophenolate mofetil medications for several months to prevent complications. Procedures during the study may include SPECT imaging and collection of blood and bone marrow samples. Participants are monitored for side effects up to 100 days after transplant and then checked at 6, 9, 12, 18, and 24 months. Researchers will measure the incidence of serious toxicities related to the Bearman regimen within 100 days post-transplant. The study involves regular assessments of blood tests, imaging, and clinical evaluations to track safety and treatment effects over two years.

Researchers are evaluating a treatment for adults aged 18 to 75 with high-risk acute leukemia or myelodysplastic syndrome that has returned or is not responding to treatment. This phase I/II trial studies the side effects and the best dose of a radioactive antibody called 211At-BC8-B10. This antibody may help prevent cancer cells from growing and spreading. The study also looks at the effects of donor stem cell transplant and medicines to prevent graft versus host disease, where donor cells attack normal cells in the body. Participants receive an infusion of the radioactive antibody 211At-BC8-B10 over 6 to 8 hours on day -8. This is followed by chemotherapy drugs fludarabine and cyclophosphamide on days -6 to -2 and -6 and -5, respectively. Total body irradiation is given on day -1. On day 0, patients undergo stem cell transplant from a donor, either from peripheral blood or bone marrow. After transplant, patients receive medicines including cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. Granulocyte colony-stimulating factor is started on day 5 to help recover white blood cell counts. During the study, patients have bone marrow biopsies, blood sample collections, and other tests. They are followed closely with visits up to two years after treatment to monitor side effects, especially serious toxicities within 100 days after transplant. The main outcome measured is the proportion of patients who develop severe side effects from the treatment. This research helps understand the safety and appropriate dosing of the radioactive antibody combined with stem cell transplant for these blood cancers.

Researchers are evaluating remibrutinib (LOU064) in adolescents aged 12 to under 18 years who have chronic spontaneous urticaria (CSU) that is not well controlled by H1-antihistamines. This Phase 3 trial aims to assess the effectiveness, how the drug is processed in the body, and safety of remibrutinib compared to a placebo. The study also intends to gather long-term data on how well remibrutinib works and its safety over several years after treatment ends. The trial includes three periods. First, the core period is a 24-week double-blind phase where about two-thirds of participants receive remibrutinib and one-third receive placebo, with about 10 site visits over approximately 32 weeks. Next is an optional open-label extension lasting from one to three years, where participants who completed the core period may receive remibrutinib or enter an observational treatment-free phase depending on their symptoms. Participants may cycle through treatment and observational periods up to six times. Finally, an optional long-term treatment-free follow-up can last up to three years with one site visit and up to four phone calls. During the study, participants undergo assessments including changes in urticaria activity scores (UAS7), itching severity (ISS7), and hive severity (HSS7) measured from baseline to 12 weeks. Regular visits monitor safety, symptoms, and drug effects. The study tracks these measures to understand remibrutinib's impact on CSU symptoms and overall safety profile during and after treatment, with total participation potentially lasting several years.

Researchers are evaluating 4D-710, an investigational gene therapy, in adults with cystic fibrosis (CF) lung disease who cannot use or tolerate CFTR modulator therapy. This Phase 1/2, multicenter, open-label trial also includes a sub-study assessing 4D-710 in adults with advanced CF lung disease or frequent lung flare-ups despite using CFTR modulators. The study aims to assess the safety, tolerability, and early effectiveness of this gene therapy in these populations. The trial involves a single dose of 4D-710, which is a gene therapy using a specialized virus to deliver a modified CFTR gene. Participants receive this treatment once, and those in the sub-study must be on a stable CFTR modulator regimen for at least 60 days before screening and continue it during a 24-month observation period. The study monitors participants with CF lung disease ranging from moderate to advanced stages. During the study, participants undergo regular evaluations including lung function tests, oxygen level checks, and monitoring for adverse effects. Researchers track the occurrence and severity of any side effects over a 60-month period. The study also includes assessments of lung health, medication adherence, and clinical status to understand the therapy's impact and safety over time.

Researchers are investigating the effects of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years who have primary or secondary hypogonadism. This Phase 3/4, open-label, multicenter study aims to evaluate how well XYOSTED supports puberty continuation or induction, as well as its dosage, safety, and testosterone level outcomes. Participants have a confirmed deficiency or absence of endogenous testosterone and will be assessed for pubertal development and hormone levels before starting treatment. Participants will receive XYOSTED injections with dosages tailored to their weight and targeted Tanner Stage of puberty. Dose adjustments will be made regularly based on serum total testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach desired testosterone levels. After completing the 52-week primary study, participants may join a 24-month long-term safety extension with clinic visits every six months for ongoing clinical, laboratory, and pharmacokinetic assessments. During the study, participants will undergo thorough clinical examinations including pubertal staging, multiple testosterone measurements, and monitoring for safety and pharmacokinetics throughout treatment and extension periods. Researchers will track changes in testosterone levels from enrollment through week 53 and monitor overall safety. The study includes detailed follow-up and dose management to support pubertal development and assess long-term effects of XYOSTED therapy in this population.

Researchers are evaluating how well fluorine F 18 fluorthanatrace ([18F]FTT) positron emission tomography (PET) works for imaging patients with metastatic breast cancer. This cancer has spread from the original site to other parts of the body. The study focuses on patients receiving standard treatments with PARP inhibitors, with or without immune checkpoint inhibitors (ICI). [18F]FTT is a radiotracer that binds to PARP1, an enzyme involved in cancer cell repair, and can help visualize tumor cells expressing PARP1 using PET scans. The goal is to better detect how tumors respond to these therapies. Participants are assigned to one of two groups. In both groups, patients receive [18F]FTT intravenously and have a PET scan 60 to 75 minutes later on the first day of starting PARP inhibitor ± ICI treatment. Group 1 has an additional PET scan at 12 weeks and undergoes FDG PET/CT scans and follow-ups at 12 weeks and 6 months, with possible tissue biopsies during screening and follow-up. Group 2 has one PET scan on day 1 and FDG PET/CT scans with follow-ups at 12 weeks and 6 months, and may have a biopsy during screening. After the initial [18F]FTT PET scan, patients are monitored for up to 6 months or until disease progression. During the study, participants undergo PET scans, FDG PET/CT scans, and may have breast biopsies. Researchers review medical records and monitor treatment response by measuring overall response rate from baseline up to 6 months. Patients must follow the study schedule, including visits and exams. Safety and effectiveness of imaging and treatments are assessed throughout the study period.

Researchers are evaluating the performance of two different polyurethane male condoms with varying sizes and thicknesses compared to a standard natural rubber latex male condom in healthy monogamous couples. The study aims to determine how often each condom type breaks or slips off during vaginal intercourse and to assess how well couples tolerate and like using each condom type. This investigation is designed to provide a comparison of the effectiveness and user experience of these condom types. During the study, couples will use each condom type—two different polyurethane condoms and one latex condom—in a randomized, crossover design. For each condom type, couples will receive between 5 and 7 condoms to use during vaginal intercourse over a maximum 5-week period. Each couple will repeat this assessment period for all three condom types, allowing direct comparison of performance. The study also evaluates tolerance and any problems such as irritation or discomfort during use. Participants will be asked to respond to questionnaires and scales shortly after intercourse to report on condom use and any issues experienced. Researchers will monitor total clinical failure rates, defined as condom breakage or slippage within 8 hours following each sexual act. Couples must have internet access to upload questionnaire data and will be followed up throughout the study. The trial includes detailed assessments of condom performance, user satisfaction, and safety over the course of the investigation.

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.