Munro

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Researchers are evaluating whether eptinezumab can reduce the number of migraine days in young people aged 12 to 17 who have chronic migraine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to compare eptinezumab with a placebo in preventing chronic migraine in adolescents. Participants must have a history of chronic migraine for at least six months as defined by recognized headache disorder guidelines. Participants will receive a single intravenous infusion of either eptinezumab at doses of 100 mg or 300 mg, adjusted by body weight to match adult exposure, or a placebo solution. The study includes a 4-week screening period, followed by a 12-week double-blind treatment period, and then an 8-week safety follow-up. Participants are randomly assigned in a 1:1:1 ratio to one of the three groups. Throughout the study, participants will complete headache diaries to record migraine frequency and characteristics. Researchers will measure the change from baseline in monthly migraine days averaged over the first 12 weeks of treatment to assess efficacy. Safety monitoring continues through the follow-up period, with the total participation lasting approximately 24 weeks from screening through follow-up.

Researchers are evaluating adults with advanced small cell lung cancer (SCLC) in this study. The main goal is to see if adding a medicine called obrixtamig to the usual treatment, which includes atezolizumab, carboplatin, and etoposide, helps patients live longer compared to the usual treatment alone. Obrixtamig is an antibody-like drug that may support the immune system in fighting cancer. The study also tests a new medical device designed to measure levels of a tumor marker called DLL3. Participants are randomly assigned to one of two groups. One group receives obrixtamig along with the standard treatment, while the other group gets only the standard treatment. All medicines are given through a vein. Those receiving obrixtamig must stay overnight at the study site after their first two treatments with this medicine. Treatment continues as scheduled, following the same general approach for both groups. During up to three years of participation, patients regularly visit the study site for tumor size assessments and health checks. Researchers monitor side effects and compare the results between the two groups to determine treatment effectiveness. The main outcome measured is overall survival over this period.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

The International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry is an ongoing global observational program tracking routine clinical outcomes in patients diagnosed with Gaucher disease. It includes patients regardless of their treatment status and aims to improve understanding of the variability, progression, and natural history of Gaucher disease. The Registry also seeks to support the medical community by developing monitoring recommendations, characterizing the patient population, and evaluating long-term treatment effectiveness of imiglucerase and eliglustat. The Registry involves no experimental treatments; patients receive clinical assessments and care as directed by their treating physicians. Additionally, there is a Gaucher Pregnancy Sub-registry that monitors pregnancy outcomes, complications, and infant growth up to 36 months postpartum for women with Gaucher disease. This Sub-registry collects medical and obstetric history and pregnancy data for participants who consent, without altering their standard care. Participants provide data through routine clinical visits, and researchers collect medical information to better understand patient outcomes and optimize care. The Registry tracks outcomes over long periods, including up to 42 years, to support ongoing care improvements. Women in the Pregnancy Sub-registry have additional data collected on pregnancy and infant growth, contributing to comprehensive monitoring of Gaucher disease impacts during and after pregnancy.

Researchers are evaluating the safety and effectiveness of TARA-002, given directly into the bladder, in adults aged 18 years or older with high-grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without Ta/T1. This Phase 2, open-label study focuses on participants who have active disease confirmed at their last tumor evaluation, enrolling them into two groups based on their prior exposure to BCG treatment. All participants receive six weekly doses of TARA-002 at a dose established in a previous Phase 1 study during the first treatment period. Those eligible for reinduction receive six more weekly doses in the second treatment period. Participants who achieve a complete response after the first treatment receive three additional weekly doses as maintenance during the second period. A third treatment period provides all eligible participants with three weekly doses at months 6, 9, 12, 15, and 18. Following treatment, participants enter a follow-up phase lasting from month 21 to month 60. During the study, researchers assess the occurrence of a high-grade complete response at any time from month 3 to month 60, including subgroup analyses for certain cohorts. Participants undergo pathology reviews to confirm response. The study monitors safety and efficacy throughout treatment and long-term follow-up, with evaluations designed to capture the duration and quality of the treatment response over several years.