* AERIFY 2
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled, parallel group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)
IRAS ID
291436
Contact name
Anthony De Soyza
Contact email
Sponsor organisation
Sanofi Aventis
Eudract number
2020-001819-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1250-2843, WHO
Duration of Study in the UK
2 years, 11 months, 15 days
Research summary
Currently available therapies for COPD have modest efficacy and/or important safety concerns, so the purpose of the study is to investigate the effect, safety, and tolerability of itepekimab/SAR440340 for the treatment of patients with COPD, who continue to have symptoms on current treatment and who need an additional treatment to their current COPD management.
This is double-blind, placebo-controlled, parallel group study design. Participants will be randomised on the following basis:
Former Smokers:
Participants will be randomised on a 1:1:1 ratio to receive either 300mg itepekimab once every 2 weeks, itepekimab/placebo once every 2 weeks alternating or placebo once every 2 weeks. This is given via a subcutaneous injection and will be given in addition to their current controller therapy.
Current Smokers:
Participants will be randomised on a 1:1 ratio to receive the 300mg itepekimab once every 2 weeks or placebo once every 2 weeks. This is given via a subcutaneous injection and will be given in addition to their current controller therapy.If the participant consents they will be required to attend at least 16 onsite visits at different intervals over a 75/77 week period. Assessments will include blood and urine samples, physical examinations and vital signs. A chest X-ray maybe required at screening if one hasn't been recorded in the last 6 months. The participant will also be asked to complete Spirometry to assess their pulmonary function and be required to complete a number of questionnaires to assess their COPD.
The primary endpoint is calculated by annualised rate of moderate-or-severe acute exacerbation of COPD (AECOPD)a over the 52-week placebo-controlled treatment period
• The primary estimand will be a treatment policy estimand.The study will include approximately 1170 participants, around 16 from the UK.
A pharmaceutical company (Sanofi Aventis) is sponsoring this study.
This study is planned to take part in 4 NHS centres in the UK.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0182
Date of REC Opinion
11 Feb 2021
REC opinion
Further Information Favourable Opinion