A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

NCT07456033 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2229262025-524463-20
• Study Type: interventional
• Target: 456
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Asthma

Keywords

GSK3511294; Depemokimab; MODIFY; Type 2 asthma

Outcome Measures

Primary Outcomes (1)

• Annualized rate of clinically significant exacerbations

  A clinically significant exacerbation is defined as a worsening of asthma requiring the use of systemic corticosteroids.

  Up to Week 156

Secondary Outcomes (5)

• Proportion of participants with clinical remission at 2 years

  At 2 years

• Change from Baseline in Asthma Quality of Life Questionnaire (AQLQ) total overall score at 2 years

  Baseline and at 2 years

• Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at 2 years

  Baseline and at 2 years

• Change from Baseline in post-Bronchodilator Forced expiratory volume in 1 second (FEV1) at 2 years

  Baseline and at 2 years

• Change from Baseline in pre-Bronchodilator FEV1 at 2 years

  Baseline and at 2 years

Study Arms (2)

Depemokimab

EXPERIMENTAL

Participants will be administered depemokimab along with standard of care (SoC).

Drug: Depemokimab

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo along with SoC

Drug: Placebo

Interventions

Depemokimab DRUG

Depemokimab will be administered

Also known as: GSK3511294

Depemokimab

Placebo DRUG

Placebo will be administered

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Type 2 high disease at risk of asthma exacerbations as defined by either:

You may not qualify if:

• Participants have had 3 or more exacerbations in the last year prior to Visit 1.
• Participants on maintenance OCS or high dose ICS/LABA for asthma.
• Participants with a duration of asthma greater than (\>)20 years.
• Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.
• Participants with other conditions that could lead to elevated EOS such as hypereosinophilic syndromes including (but not limited to) Eosinophilic Granulomatosis with Polyangiitis (formerly known as Churg-Strauss Syndrome) or eosinophilic esophagitis.
• Participants who developed an exacerbation within 4 weeks before screening.
• Participants with a known, pre-existing parasitic infestation within 6 months prior to screening unless treated and evidenced to have been resolved.
• A known immunodeficiency (e.g. human immunodeficiency virus), other than that explained by the use of CS taken as therapy for asthma.
• A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
• Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, psychiatric, renal, gastrointestinal, hepatic, hematologic or any other system abnormalities that are uncontrolled with standard treatment.
• Participants with current diagnosis of vasculitis.
• Participants who have received treatment with any approved or investigational biologic monoclonal antibody (mAb).
• A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to the first dose of study intervention.
• Current smokers or former smokers with a smoking history of \>=20 pack years (number of pack years = \[number of cigarettes per day/20\] \* number of years smoked) and vapers.
• Participants with allergy/intolerance to a mAb or biologic or any of the excipients of depemokimab.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is double-blind, placebo-controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.