Dupilumab for COPD
(NOTUS Trial)

Recruiting in Palo Alto (17 mi)

+978 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sanofi

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by * Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo * Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) * Pre-bronchodilator FEV1 over 52 weeks compared to placebo * Lung function assessments * Moderate and severe COPD exacerbations * To evaluate safety and tolerability * To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

Eligibility Criteria

This trial is for adults with moderate to severe COPD who have signs of Type 2 inflammation, a history of smoking, and frequent flare-ups despite taking regular medication. They should not have asthma or other significant lung diseases besides COPD, nor should they require high levels of oxygen or have had certain lung procedures.

Inclusion Criteria

You have smoked the equivalent of at least 10 packs of cigarettes per year for 1 year.

I have had a cough with mucus most days for 3 months.

I have been on a stable dose of lung medication for at least 1 month.

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Exclusion Criteria

I have had, or will have, surgery to remove all or part of a lung and am not currently in the early stages of lung rehab.

I do not have serious lung conditions other than COPD.

I have been diagnosed with α-1 anti-trypsin deficiency.

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Treatment Details

Interventions

Dupilumab SAR231893 (Monoclonal Antibodies)
Inhaled Corticosteroid (Corticosteroid)
Inhaled Long-Acting Beta Agonist (Long-Acting Beta Agonist)
Inhaled Long-Acting Muscarinic Antagonist (Long-Acting Muscarinic Antagonist)

Trial OverviewThe study tests Dupilumab's effectiveness in reducing COPD flare-ups and improving breathing when given every two weeks. It compares this treatment to a placebo while patients continue their usual inhalers (corticosteroids, long-acting muscarinic antagonists, and beta agonists).

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment4 Interventions

Participants received dupilumab 300 mg subcutaneous (SC) injection every 2 weeks (q2w) up to 52 weeks

Group II: PlaceboPlacebo Group4 Interventions

Participants received placebo matched to dupilumab 300 mg SC injection q2w up to 52 weeks