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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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
GSK Investigational Site
RECRUITING
Little Rock
California
GSK Investigational Site
RECRUITING
Newport Beach
Colorado
GSK Investigational Site
RECRUITING
Aurora
Florida
GSK Investigational Site
RECRUITING
Aventura
GSK Investigational Site
RECRUITING
Kissimmee
GSK Investigational Site
RECRUITING
Lake Worth
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
Louisiana
GSK Investigational Site
RECRUITING
Shreveport
Oklahoma
GSK Investigational Site
RECRUITING
Oklahoma City
Pennsylvania
GSK Investigational Site
RECRUITING
Dubois
GSK Investigational Site
RECRUITING
Wyomissing
South Dakota
GSK Investigational Site
RECRUITING
Rapid City
Texas
GSK Investigational Site
RECRUITING
San Antonio
Virginia
GSK Investigational Site
RECRUITING
Burke
Other Locations
United Kingdom
GSK Investigational Site
RECRUITING
Bradford
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2026-03-13
Estimated Completion Date: 2030-09-23
Participants
Target number of participants: 456
Treatments
Experimental: Depemokimab
Participants will be administered depemokimab along with standard of care (SoC).
Placebo_comparator: Placebo
Participants will be administered placebo along with SoC
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov