Phase 3: testing Tezepelumab for Chronic Obstructive Pulmonary Disease (COPD)

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tezepelumab, or Placebo. The registry lists allocation as randomized. A Multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, Parallel Group, Phase 3 Study to measure the how well it works and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

They plan to enroll about 990 people at 237 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Interventions: Tezepelumab, Placebo

Primary outcome (registry wording): Annualised rate of moderate or severe COPD exacerbations

Who it is for (from inclusion criteria)

• Ages 40 Years to 80 Years
• ≥40 to ≤80 years old
• COPD diagnosis ≥1 year,
• Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
• Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
• EOS ≥ 150 cells/μL during screening
• CAT ≥15 at screening
• Former or current smokers ≥10 pack-years