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The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre 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
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524463-20-00
Enrollment
45
Registered
2026-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

1. Annualized rate of clinically significant exacerbations over the treatment period.

Detailed description

1. Clinical remission at 2 years (104 weeks), defined as: • No clinically significant asthma exacerbations during the first 2 years of the treatment period and • No maintenance OCS for asthma at 2 years and • Well controlled asthma based on an ACT ≥20 at 2 years and • No deterioration of lung function. Deterioration is defined as a reduction in post-BD FEV1 of more than 0 ml at 2 years compared to baseline., 2. Change from baseline in AQLQ total overall score at 2 years, in participants with baseline ACQ-5 ≥1.5., 3. Change from baseline in ACQ-5 score at 2 years, in participants with baseline ACQ-5 ≥1.5., 4. Change from baseline of post-BD FEV1 at 2 years., 5. Change from baseline of pre-BD FEV1 at 2 years.

Interventions

DRUGEXDENSUR 100 mg solution for injection in pre-filled syringe
DRUGSterile 0.9% (w/v) sodium chloride solution in single-use PFS.

Sponsors

Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Annualized rate of clinically significant exacerbations over the treatment period.

Secondary

MeasureTime frame
1. Clinical remission at 2 years (104 weeks), defined as: • No clinically significant asthma exacerbations during the first 2 years of the treatment period and • No maintenance OCS for asthma at 2 years and • Well controlled asthma based on an ACT ≥20 at 2 years and • No deterioration of lung function. Deterioration is defined as a reduction in post-BD FEV1 of more than 0 ml at 2 years compared to baseline., 2. Change from baseline in AQLQ total overall score at 2 years, in participants with baseline ACQ-5 ≥1.5., 3. Change from baseline in ACQ-5 score at 2 years, in participants with baseline ACQ-5 ≥1.5., 4. Change from baseline of post-BD FEV1 at 2 years., 5. Change from baseline of pre-BD FEV1 at 2 years.

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 17, 2026