Sakura

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are evaluating pasritamig JNJ-78278343 combined with best supportive care BSC compared to placebo with BSC in men with metastatic castration-resistant prostate cancer mCRPC, a form of prostate cancer that has spread and no longer responds to hormone therapies. This Phase 3 randomized, double-blind study aims to assess overall survival, measuring how long participants live from the start of the study until death from any cause. Participants will be randomly assigned to receive either pasritamig or placebo through intravenous infusion. The dosing starts with step-up doses on Cycle 1 Day 1 and Day 8, followed by a target dose on Day 15. Subsequent cycles of treatment occur every 6 weeks, with Cycle 1 lasting 8 weeks and later cycles lasting 6 weeks each. All participants may also receive best supportive care, which includes treatments like radiation, steroids, pain medication, and other palliative procedures, at the physicians discretion. Treatment continues until disease progression, intolerable side effects, withdrawal, death, or end of study. During the study, participants will have regular assessments to monitor overall survival and other outcomes such as progression-free survival, symptomatic progression, skeletal-related events, and time to pain or fatigue worsening. Laboratory tests and monitoring for adverse events will occur up to 2 years and 8 months. Participants will receive ongoing evaluation to track treatment effects and safety throughout the trial duration, which spans until August 2028.

Researchers are evaluating the safety and tolerability of valemetostat in combination with darolutamide in adult males with Metastatic Castration Resistant Prostate Cancer mCRPC. This Phase 1, multicenter trial aims to understand how these drugs work together in this advanced prostate cancer form that continues to progress despite hormone therapy. The study includes two parts a dose escalation phase where valemetostat is given at increasing doses alongside a standard dose of darolutamide, and a dose expansion phase where valemetostat is administered at two or more dose levels with darolutamide. Participants receive these treatments to assess safety, tolerability, and preliminary efficacy. During the trial, participants are monitored from screening through approximately five years. Researchers will track dose-limiting toxicities, treatment-emergent adverse events, and various measures of prostate cancer activity including PSA response rates, radiographic progression-free survival, overall survival, and time to symptomatic bone events. Blood levels of valemetostat are also measured during treatment cycles to understand drug exposure and effects.

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color due to the immune system mistakenly attacking pigment-producing skin cells called melanocytes. This leads to patches of skin with less or no pigment, often appearing symmetrically on both sides of the body in the nonsegmental form of vitiligo. The study aims to evaluate the safety, effectiveness, and tolerability of the drug zasocitinib in adults with nonsegmental vitiligo. Participants will receive oral capsules of zasocitinib at low, medium, or high doses for up to 52 weeks. Some participants will initially receive a placebo for 24 weeks, then switch to medium or high doses of zasocitinib for the remainder of the study. The placebo capsules look identical to zasocitinib but do not contain active medicine. The study uses a randomized, double-blind design with several experimental groups receiving different doses or placebo. During the study, participants will visit the clinic 11 times over one year. Researchers will assess the improvement in vitiligo using facial and total Vitiligo Area Scoring Index F-VASI and T-VASI at baseline and week 24. Safety and tolerability will also be monitored throughout. The primary outcome is the percentage of participants achieving at least 75% improvement in F-VASI at week 24. Secondary outcomes include other measures of vitiligo area improvement. Participants health and response to treatment will be closely followed until the studys end.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.