Oakville

Researchers are evaluating ALD-102 Solution in adults with alopecia areata to determine its safety, tolerability, and effect on hair regrowth. This first-in-human clinical trial compares ALD-102 injections in the scalp to placebo injections and untreated areas. The study aims to understand treatment-related side effects and hair regrowth outcomes in affected scalp areas. Participants receive injections of ALD-102 Solution or placebo once every 4 weeks over an 8-week treatment period. Different scalp areas are selected for treatment, placebo, or no treatment depending on the cohort. The study includes multiple injections per treatment area, with dosing adjusted by cohort. This randomized, triple-blind study monitors participants for adverse effects and drug levels. Throughout the trial, participants undergo clinical assessments, local tolerability evaluations, and safety monitoring for 24 weeks. Skin biopsies and blood samples are collected to measure ALD-102 concentrations. Researchers track hair regrowth and adverse events using standardized scales and assessments. Participants are required to follow study procedures and maintain consistent hair styling during the study duration.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

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.

This research aims to evaluate how well and safely orforglipron works in adult female participants with stress urinary incontinence SUI who also have obesity or are overweight. SUI is a condition where urine leaks during activities such as coughing or exercising. The study is a Phase 3 clinical trial conducted under a master protocol supporting two independent studies, focusing on this specific population. Participants will be randomly assigned to receive either orforglipron or a placebo, both given orally once daily. The study uses a double-blind design with parallel groups to compare the effects of orforglipron against placebo. The treatment period lasts approximately 52 weeks, followed by safety follow-up, making total participation about 58 weeks from screening to study completion. During the study, participants will undergo assessments including measuring changes in the frequency of incontinence episodes, body weight, quality of life related to urinary incontinence, use of continence pads, and cholesterol levels. Researchers will monitor waist circumference and patient impressions of their condition as well. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

This research aims to evaluate the effects of vedolizumab intravenous IV combined with either adalimumab or ustekinumab in adults with moderate to severe Crohns Disease who have not responded adequately or have lost response to certain prior treatments. The study investigates the safety and efficacy of these dual targeted therapies, followed by vedolizumab alone. Approximately 100 participants will be enrolled, with the overall study duration lasting about 76 weeks. Participants in Part A will receive dual targeted therapy one group will get vedolizumab IV plus adalimumab subcutaneous injections, and another group will receive vedolizumab IV combined with ustekinumab through initial IV infusion followed by subcutaneous doses. Those who respond to Part A treatment will continue in Part B, receiving vedolizumab IV monotherapy every 8 weeks from Week 30 to Week 46. After treatment, participants will have a safety follow-up period extending to Week 72. During the study, participants will undergo multiple assessments including endoscopic evaluations using the Simple Endoscopic Score for Crohns Disease SES-CD at Weeks 26 and 52. Clinical remission and symptom remission will be tracked at various time points using the Crohns Disease Activity Index CDAI and patient-reported outcome measures. Safety monitoring and follow-up continue for at least 26 weeks after the last treatment dose to evaluate treatment effects and adverse events throughout the study period.

Researchers are evaluating the effect of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults aged 18 to 65 with moderate to severe ulcerative colitis who have not responded adequately to certain prior treatments. This phase 4 study focuses on clinical remission rates and treatment response in this population, aiming to understand the benefits of dual targeted therapy followed by vedolizumab alone. All participants first receive vedolizumab 300 mg via IV infusion at Weeks 0, 2, and 6 plus tofacitinib 10 mg tablets twice daily from Week 0 to Week 8. Those who respond clinically at Week 8 continue with vedolizumab 300 mg IV every 8 weeks alone through Week 46. The study lasts up to 76 weeks including treatment and follow-up. Participants undergo clinical assessments including Mayo score evaluations at multiple timepoints to measure remission and response. Safety is monitored through adverse event tracking and laboratory tests up to 26 weeks after the last vedolizumab dose. Patient questionnaires on quality of life and fatigue are also collected, with total participation extending over a year.

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 Corabotase also known as IPN10200 to assess its effectiveness and safety compared to a placebo for improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a persons confidence. This Phase III, multicenter, randomized, double-blind study aims to measure treatment response and participant satisfaction. Participants will be randomly assigned to receive a single injection of either Corabotase or placebo into the muscles between the eyebrows during one treatment visit on Day 1. The study includes a screening period up to 20 days to determine eligibility, followed by the treatment day and a 52-week follow-up period. During follow-up, participants will have regular visits and one phone call to monitor their health and treatment effects. Throughout the study, participants will undergo physical exams, blood tests, heart electrical activity recordings ECG, clinical evaluations, questionnaires, and keep a diary. The research team will measure improvement in glabellar lines at various time points up to one year, along with participant satisfaction and safety events. Participants may withdraw from the study at any time, and the total participation lasts up to 55 weeks.

This research aims to collect long-term safety and effectiveness data on palovarotene in children and adults with fibrodysplasia ossificans progressiva FOP, a very rare and disabling disease characterized by abnormal bone growth where bone should not form. The study will include participants who are either already receiving palovarotene as prescribed or are not treated with palovarotene. It seeks to assess real-world outcomes, including flare-up episodes, growth, and bone fractures, comparing those treated and untreated with palovarotene. Participants will be observed in two groups those exposed to palovarotene and those unexposed. The study will document safety events related to palovarotene from baseline until 30 days after the last dose. Effectiveness will also be described by monitoring physical function, use of assistive devices, lung function, flare-up characteristics, and pregnancy outcomes. Data collection will occur regularly over an extended period, up to eleven years. During the study, participants will undergo assessments every six months or annually for measures such as joint involvement, physical function questionnaires, lung capacity tests, and flare-up tracking. Pregnancy outcomes and developmental follow-up of babies will be monitored monthly during pregnancy and up to one year after birth. The main safety outcomes include the frequency and seriousness of adverse events related to palovarotene. Overall, participation can last up to eleven years with ongoing monitoring to understand long-term impacts.