Granada

Researchers are evaluating the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition that causes long-lasting painful red lumps on the skin. The study focuses on participants who have not responded well to or cannot tolerate antibiotics for HS. This Phase 2, randomized, double-blind, placebo-controlled study aims to understand how Ritlecitinib compares to placebo in treating this condition. Participants will be randomly assigned to take either Ritlecitinib or a matching placebo by mouth once daily at home. The study includes a loading dose of Ritlecitinib for the first 8 weeks, followed by a maintenance dose for the next 8 weeks, totaling 16 weeks of treatment. The placebo group will follow the same schedule with a pill that looks like the study medicine but contains no active drug. Throughout the study, participants will have about 10 clinic visits over approximately 24 weeks, including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until Week 16. At these visits, health status will be reviewed through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also record daily medication intake and HS symptoms using a mobile eDiary. Researchers will measure skin response and safety outcomes to assess the effects of the study medicine compared to placebo.

This trial evaluates the effectiveness of adjuvant cemiplimab immunotherapy in adults with surgically removed stage II-IIIA non-small cell lung cancer NSCLC who have not previously received adjuvant platinum-based chemotherapy. The study aims to compare disease-free survival between patients treated with cemiplimab and those under observation without additional treatment, focusing on patients with tumors showing PD-L1 expression of 1% or higher. Participants are randomly assigned to receive either cemiplimab or observation. Those in the cemiplimab group receive 350 mg intravenously every 3 weeks for 4 cycles, followed by 700 mg every 6 weeks for up to 6 cycles or until disease relapse or unacceptable side effects occur. The observation group does not receive adjuvant treatment. Treatment continues until relapse, toxicity, or completion of planned cycles. During the trial, participants undergo regular assessments including imaging and laboratory tests to monitor disease status and side effects. The main outcome measured is disease-free survival, tracked for approximately 59 months from randomization. Secondary outcomes include overall survival and the nature and severity of adverse events. Participants are monitored for safety and treatment response throughout the study period, which is expected to conclude in March 2029.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

This research investigates ASTX030, a combination of azacitidine and cedazuridine, given alone or with venetoclax for people with myeloid neoplasms and acute myeloid leukemia AML. The study includes multiple phases, from early dose-finding stages to larger randomized trials, evaluating the safety, pharmacokinetics, and effectiveness of ASTX030 compared to standard subcutaneous azacitidine. It aims to understand how these treatments work in participants with myelodysplastic syndromes MDS, chronic myelomonocytic leukemia CMML, and AML over approximately eight years. The study involves several treatment arms early phases focus on dose escalation and expansion of oral ASTX030 later phases compare oral ASTX030 to subcutaneous azacitidine in randomized crossover designs. Combination therapy arms test ASTX030 plus venetoclax against azacitidine plus venetoclax with specific dosing schedules over 28-day cycles. Participants may switch treatments after initial cycles. Treatments include oral tablets, capsules, and injections, with some doses taken in a fasted or fed state. Participants will undergo regular cycles of treatment with detailed monitoring including blood tests to measure drug levels and responses, assessments of side effects, and evaluations of disease status. Researchers will track outcomes like drug exposure, response rates, survival, and safety over months to years. This includes measuring DNA methylation changes, transfusion independence, and adverse events. The study is open to adults and includes ongoing safety and effectiveness follow-up.

Researchers are evaluating zanidatamab combined with chemotherapy for treating people with HER2-positive, early-stage breast cancer. This phase 2 study aims to assess the safety and effectiveness of this combination compared to standard treatments in participants with newly diagnosed stage II or III invasive breast carcinoma. Participants are randomly assigned to one of three treatment groups zanidatamab with paclitaxel, zanidatamab with docetaxel and carboplatin, or trastuzumab and pertuzumab with docetaxel and carboplatin. All study drugs are administered intravenously. After neoadjuvant therapy, participants will undergo either mastectomy or breast conserving surgery as decided by their physician. During the study, participants will have their response to treatment assessed through measurements such as pathologic complete response and residual cancer burden classification up to 8 months. Safety is monitored by tracking treatment-related adverse events up to 23 months. Other assessments include survival outcomes up to 46 months and serum concentrations of zanidatamab. The study participation may last several years to capture these outcomes.

Researchers are evaluating a new medication called VH4524184 for treating adults with HIV-1 who have never received treatment before. This Phase 2b study compares two doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide FTCTAF, against a standard HIV treatment combining dolutegravir and lamivudine DTG3TC. The goal is to collect long-term data on the antiviral activity of VH4524184 and to understand the best dosing for future studies. Participants are assigned to one of several groups one group receives a low dose of VH4524184 plus FTCTAF daily for 12 months, another group receives a high dose of VH4524184 plus FTCTAF daily for 12 months, and a third group takes DTG and 3TC daily for 24 months. After 12 months, those on VH4524184 may continue with a selected dose combined with FTCTAF daily until month 24. All medications are taken orally. During the study, participants attend scheduled visits for assessments including blood tests to measure HIV-1 RNA levels, CD4 T-cell counts, and drug concentrations. Researchers monitor the percentage of participants achieving viral suppression at 12 months and maintain it through 24 months. Safety is closely observed through tracking adverse events until roughly month 36. The total participation time may span up to 36 months to evaluate the long-term effects and safety of the treatments.

Researchers are studying a treatment approach for adult men with PSMA-positive metastatic castration resistant prostate cancer mCRPC who have previously received one androgen receptor pathway inhibitor ARPI and may or may not have had taxane chemotherapy. This phase IbII trial aims to first evaluate the safety, tolerability, and how the body processes the drug AMO959 combined with lutetium 177Lu vipivotide tetraxetan AAA617 and ARPI. Then, it will assess the preliminary effectiveness of this combination in patients who have not yet been treated with taxane chemotherapy for mCRPC. The study includes two phases Phase Ib with small groups receiving escalating doses of AMO959 alone, then combined with AAA617 and ARPI abiraterone or enzalutamide to determine the recommended dose and Phase II where participants are assigned to treatment arms receiving AMO959 with AAA617 and ARPI, AAA617 with ARPI, or other dosing regimens. Treatments involve taking AMO959 twice daily for 14 days followed by combinations with AAA617 every six weeks for up to six cycles, along with continuous ARPI therapy. Participants will undergo safety monitoring for side effects and dose adjustments during treatment lasting up to about two years. The study measures include biochemical responses like PSA levels, progression-free survival, overall response rates, and quality of life assessments. Blood samples will track drug levels and radiation doses. Follow-up continues to monitor adverse events and disease progression for up to nearly four years from treatment start, with regular visits during treatment cycles.

Researchers are evaluating treatment options for patients with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary who have no remaining tumor after primary tumor debulking surgery. This phase II, multicenter, randomized, open-label study aims to compare the recurrence-free survival between patients receiving 3 cycles versus 6 cycles of carboplatin plus paclitaxel chemotherapy, followed by maintenance therapy with niraparib. Participants are randomly assigned to one of two treatment groups one group receives 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance therapy, while the other group receives 6 cycles of the same chemotherapy followed by niraparib maintenance. Niraparib maintenance therapy starts at a dose of 200 mg or 300 mg once daily and continues until disease progression, unacceptable side effects, or other stopping criteria. Tumor assessments using CT or MRI scans are done at specific intervals, and the tumor marker CA-125 is measured every 12 weeks. Clinical visits for blood tests and toxicity monitoring occur regularly during chemotherapy and niraparib maintenance. During the study, participants will attend clinical visits for safety monitoring, including adverse event tracking, blood counts, physical exams every 12 weeks, and serum pregnancy tests for women of childbearing potential. Tumor evaluations occur 9 to 12 weeks after starting therapy and then every 6 months. The study will follow patients for up to 8 years to measure recurrence-free survival and other outcomes such as overall survival, quality of life, and safety. About 640 patients will be recruited across approximately 60 sites in six European countries over 36 months.

This research aims to evaluate the effectiveness and safety of a combination of three drugsinavolisib, ribociclib, and fulvestrantcompared to a placebo combined with ribociclib and fulvestrant. It focuses on people with advanced breast cancer that is resistant to endocrine therapy, specifically those with hormone receptor-positive, HER2-negative disease who have certain genetic markers related to chromosome 8p loss and no PIK3CA mutation. The study is conducted as a phase II, randomized, double-blind, placebo-controlled trial to explore treatment options in this patient group. Participants are randomly assigned to receive either inavolisib along with ribociclib and fulvestrant or a placebo with ribociclib and fulvestrant. Each drug is given according to a specific schedule outlined in the study protocol, though exact dosing details are not provided here. This setup allows researchers to compare the results and safety profiles of the combination treatment against the placebo combination over the course of the study. Throughout the trial, participants undergo regular assessments to measure treatment response, including the percentage of participants with confirmed objective response, progression-free survival, overall survival, duration of response, and clinical benefit rate. The study also tracks adverse events and patient-reported side effects using validated questionnaires. These evaluations may continue for up to approximately two years, ensuring thorough monitoring of both effectiveness and safety during the participants involvement.