Last updated: 11/24/2025 05:11:09
Depemokimab as an Extended treatmeNt Duration Biologic in Adults with Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)ENDURA -1
GSK study ID
222714
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Depemokimab In Adult Participants with COPD With Type 2 Inflammation
Trial description: Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Annualized Rate of Moderate/Severe Exacerbations
Timeframe: From Baseline up to Week 104
Secondary outcomes:
Time to First Moderate/Severe Exacerbation
Timeframe: From Baseline up to Week 104
Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52
Timeframe: From Baseline up to Week 52
Change From Baseline in Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) Total Score at Week 52
Timeframe: From Baseline up to Week 52
Annualized Rate of Exacerbations Requiring Emergency Department (ED) Visit or Hospitalization
Timeframe: From Baseline up to Week 104
Annualized Rate of Severe Exacerbations
Timeframe: From Baseline up to Week 104
Interventions:
Drug: Depemokimab
Drug: Placebo
Enrollment:
981
Observational study model:
Not applicable
Primary completion date:
2029-20-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2025 to August 2029
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 Years
Accepts healthy volunteers
No
- Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent.
- Elevated blood eosinophil count (BEC).
- The following subjects are excluded:
- Participants with a current or prior physician diagnosis of asthma.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the informed consent.
- Elevated blood eosinophil count (BEC).
- Moderate to severe COPD with frequent exacerbations, defined as:
- A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year
- A post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than (<) 0.70 and a post- bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values
- A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening
- COPD assessment test (CAT) score >=10 at Visit 1.
- Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.
- Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1.
- Body mass index (BMI) >=16 kilogram per square meter (kg/m^2).
- Male or eligible female participants.
Exclusion criteria:
- The following subjects are excluded:
- Participants with a current or prior physician diagnosis of asthma.
- Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease.
- Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
- Lung resection: Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
- Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1.
- Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day.
- Cor pulmonale – resulting in right heart failure, severe pulmonary hypertension
- Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP]).
- Unstable cardiovascular disease or arrhythmia.
- Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1).
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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