Perry Hall

Researchers are evaluating the safety and tolerability of AMG 691 in both healthy adults and adults with mild-to-moderate asthma. This Phase 1 study aims to assess how participants respond to single and multiple doses of AMG 691 compared to a placebo. The study includes adults aged 18 to 70 years and focuses on understanding the drug's effects in these populations. Participants receive either AMG 691 or a placebo through subcutaneous injections. The study includes single ascending dose and multiple ascending dose periods to carefully monitor reactions to different dosing levels. Healthy participants receive single or multiple doses, while participants with asthma receive multiple doses. Female participants must be of non-childbearing potential or use effective contraception if of childbearing potential. During the study, participants undergo medical evaluations, lung function tests, blood tests, and monitoring for any treatment-emergent adverse events over approximately 11 months. Researchers track lung function measures such as forced expiratory volume and biomarkers like blood eosinophils and exhaled nitric oxide. Safety and tolerability are closely monitored through regular assessments and questionnaires to evaluate asthma control and overall health.

Researchers are studying the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate delivered through a multidose dry powder inhaler with an electronic module (Fp/ABS eMDPI). This Phase 3 trial focuses on people aged 12 years and older who have asthma. The study also looks at the safety and tolerability of this inhaler when used four times daily over four weeks, as well as the pharmacokinetics of the combination and its individual components after a single dose. Participants will be randomly assigned to receive either the Fp/ABS combination inhaler, fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. All treatments are given as inhalation powders. The main treatment period lasts four weeks, during which the inhalers are taken four times a day. The total study duration for each participant is about 10 weeks, not counting an optional prescreening visit. Throughout the study, researchers will measure lung function changes, specifically forced expiratory volume in one second (FEV1), from baseline to week 4. Participants will undergo assessments including lung function tests and safety evaluations. The study monitors how the inhaler affects breathing over time and checks for any side effects or tolerability issues during the treatment period.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effects of ritlecitinib for treating chronic spontaneous urticaria (CSU) in adults whose condition is not well controlled by antihistamines. CSU causes itchy hives and swelling under the skin without a clear cause. This Phase 2b study compares two oral doses of ritlecitinib, 50 mg and 100 mg, with a placebo to understand if these doses are safe and effective in managing symptoms. Participants will be randomly assigned to take either 50 mg, 100 mg, or placebo capsules once daily for 12 weeks (Period A). After this, those on ritlecitinib will continue their assigned dose while those on placebo will switch to 100 mg for another 12 weeks (Period B). The study involves about 150 adult participants and compares the effects of the two ritlecitinib doses against placebo over these two 12-week periods. Participants will be involved in the study for about 8 months with up to 9 visits to the study site. During visits, they will have physical exams, hearing tests, blood tests, X-rays, and ECGs. They will also complete daily questionnaires about their urticaria symptoms using an electronic diary. Researchers will measure changes in urticaria activity and monitor for any treatment-related side effects or adverse events throughout the study.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are conducting a phase IIb, double-blind, placebo-controlled study to evaluate the efficacy and safety of tozorakimab in adults with uncontrolled asthma who are already receiving medium-to-high doses of inhaled corticosteroids. This study aims to find the appropriate dose range of tozorakimab for this population, focusing on those with documented asthma for at least 12 months and evidence of uncontrolled symptoms. Participants will receive either tozorakimab or a placebo, both administered subcutaneously. The study compares different doses of tozorakimab against placebo, while all participants continue their current medium or high dose inhaled corticosteroids combined with long-acting beta-agonists (LABA). The treatment period and dosing schedule are designed to assess the drug's impact on asthma control and exacerbations. During the study, participants will be closely monitored through asthma daily diaries, lung function tests including pre-bronchodilator FEV1 measurements, and assessments of asthma control using the ACQ-6 score. Researchers will track the annualized rate of severe asthma exacerbations over 26 to 52 weeks. Safety and adherence will be evaluated, and women of childbearing potential will have pregnancy testing and must use contraception as per local regulations. Overall participation will involve regular visits to assess health status and response to treatment.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

Researchers are evaluating the use of rademikibart as an additional treatment for adults and adolescents with asthma experiencing an acute exacerbation linked to type 2 inflammation. This Phase 2, randomized, double-blind, placebo-controlled trial aims to compare the effects of rademikibart plus standard therapy versus standard therapy alone in urgent healthcare settings. The study focuses on participants who have a history of asthma and require urgent treatment for an acute asthma exacerbation. Participants will receive either 600 mg of rademikibart administered subcutaneously via a prefilled syringe or a matching placebo injection alongside their standard asthma treatment. The trial is designed as a parallel-group study to assess the added impact of rademikibart during acute episodes. The treatment is given once during the urgent care visit for the exacerbation. Throughout the study, researchers will monitor participants for treatment failure within 28 days after randomization. Assessments include lung function tests such as FEV1, blood tests for eosinophil counts, and clinical evaluations of asthma control and exacerbation status. The trial also carefully tracks safety and efficacy outcomes during this 28-day period to understand how well rademikibart works as an add-on treatment.

Researchers are evaluating the safety of DBV712 250 micrograms (mcg) epicutaneous immunotherapy in children aged 1 to 3 years with peanut allergy. This Phase 3, randomized, double-blind, placebo-controlled study aims to observe adverse events over a 6-month treatment period. The study includes participants diagnosed by a physician with peanut allergy, confirmed by specific tests and a strict peanut-free diet. Participants will be randomly assigned in a 3:1 ratio to receive either the DBV712 250 mcg active treatment or a matching placebo patch applied to the skin. The study consists of a 6-week screening period, a 26-week double-blind treatment period, followed by an optional 18-month open-label extension where all participants can receive the active treatment. During the study, participants will be monitored for adverse events, treatment-emergent adverse events, and serious adverse events throughout the 6-month double-blind treatment period. The total study duration for each child is about 112 weeks, including follow-up assessments. Researchers will carefully evaluate safety outcomes and adherence to the treatment regimen to ensure participant well-being.