* AERIFY 3
Research type
Research Study
Full title
A Phase 2a, open label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive pulmonary disease (COPD)
IRAS ID
306118
Contact name
Samuel Kemp
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Developpement
Eudract number
2021-001654-65
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
WHO, U1111-1255-5322
Duration of Study in the UK
2 years, 7 months, 10 days
Research summary
Itepekimab is under development as a potential novel treatment for COPD. Data from a proof-of-concept Study ACT15104 (itepekimab vs placebo in addition to st&ard-of-care background therapy), provided preliminary clinical evidence that itepekimab has the potential to confer significant benefit beyond that provided by currently available therapies to patients with moderate-to-severe COPD who are former smokers.
This study will provide insights into the mechanism of action of itepekimab & the differential effect of the drug, in the airways of former & current smokers with COPD.
The primary objective of Part A of this study is to generate an airway gene expression signature for itepekimab treatment in endobronchial biopsies in an initial cohort of former smokers with COPD after 12 weeks of treatment with itepekimab. The primary objective of Part B is to validate the gene expression signature generated in Part A in a new cohort of former smokers treated with itepekimab. Additional secondary objectives of Part B are to confirm & exp& the findings of Part A in a pooled analysis of former smokers (Part A & Part B) & to evaluate differences in gene expression between former smokers & current smokers with COPD after 12 weeks of treatment with itepekimab. All participants will receive SoC controller therapy throughout the study.
Former & Current smokers with moderate to severe COPD on st&ard of care therapy will be approached to participate in the study. The study is over a 36-week period with at least 10 onsite visits. Assessments will include blood, urine & tissue samples, physical examinations & vital signs. A chest X-ray maybe required. The participant will also be asked to complete Spirometry to assess their pulmonary function. Bronchoscopy & nasal brushing will also be required & the patients will be required to complete several questionnaires to assess their COPD. The study will include approximately 60 participants, around 4 from the UKREC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0267
Date of REC Opinion
5 Nov 2021
REC opinion
Further Information Favourable Opinion