Marneuli

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohns Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease IBD. This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

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, safety, and tolerability of IMVT-1402 in adults with Graves disease who remain hyperthyroid despite treatment with antithyroid drugs ATD. The study is a randomized, double-blind, placebo-controlled Phase 2b trial aiming to compare IMVT-1402 against placebo by measuring thyroid hormone levels and ATD dose changes at Week 26. Participants receive either IMVT-1402 or placebo via subcutaneous injections once weekly. Some groups will receive IMVT-1402 for 52 weeks, others IMVT-1402 for 26 weeks followed by placebo for 26 weeks, and one group will receive placebo for 52 weeks. The study evaluates thyroid hormone levels, seronegative status for thyroid receptor antibodies, and sustained euthyroidism at multiple time points up to Week 104. During the trial, participants undergo regular assessments of thyroid hormones T3, FT3, FT4, TSH, antibody levels, and clinical status. Researchers will monitor participants up to two years to assess the proportion achieving normal thyroid function without ATD and maintaining this status over time. Safety and tolerability of IMVT-1402 are also evaluated throughout the study.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.