The MODIFY Study: A Phase 3b/4 Randomized, Double-blind, Placebo-controlled, Multi-centre Study Evaluating the Impact of Early Intervention With Depemokimab on Exacerbation Rate, Clinical Remission, Lung Function Decline, and Safety in Adults and Adolescents With at Risk Type 2 Asthma, Conducted up to 156 Weeks
The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).
• Adults and adolescents \>=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be \>=18 years of age.
• Participants must have a documented physician diagnosis of asthma for \>=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines
• Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.
‣ Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)/ Long-acting beta2-adrenergic receptor agonist (LABA).
• A well-documented requirement for treatment with low to medium dose ICS/LABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy/Single Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.
‣ Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS/LABA.
• Sex and Contraceptive/Barrier Requirements Male or eligible female Participants:
‣ Male Participants: Contraception for male participants with female partners is not required.
⁃ Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
⁃ Is a participant of nonchildbearing potential (PONCBP) OR
⁃ Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<)1%, from at least 14 days prior to the first dose of study intervention until at least 35 weeks after the last administered dose of study intervention.
⁃ A POCBP must have a negative highly sensitive serum pregnancy test at Screening Visit 1, Exit Visit 11 or Withdrawn from study visit, and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.
⁃ Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
⁃ The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention).
⁃ The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Capable of giving signed informed consent/assent as which includes compliance with the requirements Randomization inclusion criteria-
• Type 2 high disease at risk of asthma exacerbations as defined by either:
‣ An elevated peripheral blood eosinophils (EOS) count of \>=500 cells/microliter (μL) at screening or \>=500 cells/μL in the last 3 months prior to the screening visit.
∙ OR
• An elevated peripheral blood EOS count of \>=300 cells/μL at screening OR \>=300 cells/μL in the last 3 months prior to the screening visit AND
‣ Fractional exhaled nitric oxide \>=35 parts per billion (ppb) at screening. OR
⁃ Documented current Chronic Rhinosinusitis with Nasal Polyps.