Red Deer

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.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing chronic migraine. This Phase 3, randomized, double-blind, placebo-controlled trial includes an extension period and aims to measure changes in the number of monthly migraine days. Participants have chronic migraine and meet specific criteria related to headache frequency and migraine history. Participants receive Xeomin or placebo injections into muscles of the head and neck at pericranial and cervical points. The study includes two Xeomin dose groups and a placebo group during the controlled period, with all groups receiving Xeomin in the extension phase. Four treatments are given approximately 12 weeks apart over a total study duration of 52 to 55 weeks. Participants take part in 14 visits over the study period, with the first, last, and four treatment visits conducted in person and the remaining eight visits by phone or video call. Researchers collect headache and migraine data from diaries and assess changes in monthly migraine days as the primary outcome. Safety is monitored by tracking treatment-related adverse events throughout the trial.

Researchers are evaluating the use of Xeomin injections to prevent episodic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections in the muscles of the head and neck to measure changes in the number of monthly migraine days. Participants have episodic migraine with or without aura, and the study aims to assess the efficacy and safety of different Xeomin doses over time. Participants receive a series of four Xeomin or placebo injections spaced about 12 weeks apart. The study includes two experimental groups receiving different Xeomin doses and a placebo group, followed by an extension period where some participants receive Xeomin. Injections are given at specific points around the head and neck. The trial lasts approximately 52 to 55 weeks, starting with a 4 to 5 week screening period. Participants attend about 14 visits, including the first and last visits and four treatment visits conducted on-site, with other visits done remotely by phone or video call. Researchers monitor changes in monthly migraine days, headache days, and medication use, as well as any treatment-related side effects throughout the study.

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

This clinical trial investigates the efficacy and safety of bimekizumab compared with placebo in adults with palmoplantar pustulosis PPP, a skin condition causing pustules on the palms and soles. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension, aiming to evaluate treatment responses and safety outcomes in participants diagnosed with PPP for at least 24 weeks and who are candidates for systemic therapy or phototherapy. Participants are randomly assigned to one of two groups one group receives bimekizumab for the entire study duration, while the other receives placebo initially before switching to bimekizumab in the maintenance phase. Treatments are given at specified time points throughout the study, which includes an initial treatment period followed by a maintenance period under open-label conditions. During the study, participants undergo assessments including the Palmoplantar pustulosis-Investigator Global Assessment PPP-IGA response at Week 16, Palmoplantar Pustulosis Area Severity Index PPPASI responses at Weeks 8 and 16, and quality of life evaluations via the Dermatology Life Quality Index DLQI. Researchers monitor pain scores, adverse events, and serious side effects from baseline through safety follow-up up to Week 117. Participants will be closely observed through regular visits and evaluations during these periods.

Researchers are evaluating the safety and effects of the medicine ritlecitinib for adults with chronic spontaneous urticaria CSU that is not well controlled by antihistamines. CSU causes itchy hives and swelling in the skin and fatty tissue without a clear cause. This phase 2 study aims to compare two oral doses of ritlecitinib, 50 mg and 100 mg, against a placebo to learn how well they work and their safety profiles. Participants will be randomly assigned to one of three groups taking 50 mg ritlecitinib, 100 mg ritlecitinib, or a placebo, each taken once daily by mouth for 12 weeks Period A. After this, those on ritlecitinib continue their doses for another 12 weeks Period B, while those initially on placebo switch to 100 mg ritlecitinib for the same duration. Placebo capsules matching the active doses will be given to maintain study blinding. Participants will be involved in the study for about 8 months and will visit the study site up to 9 times. During visits, they will have physical exams, hearing tests, blood tests, chest X-rays, and ECGs. They will also complete daily questionnaires about their symptoms using an electronic diary. The main outcome measured is the change in their urticaria activity score after 12 weeks, along with monitoring for any side effects or adverse events throughout the study.