Efficacy & Safety of MEDI3506 in Adult with moderate to severe Asthma
Research type
Research Study
Full title
A Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MEDI3506 in Adult Participants with Uncontrolled Moderate-to-severe Asthma
IRAS ID
294720
Contact name
Brian Leaker
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-000789-40
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
140910, IND Number
Duration of Study in the UK
1 years, 1 months, 27 days
Research summary
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to investigate the effect of treatment with MEDI3506 can reduce asthmatic airway inflammation, improve epithelial integrity, reduce mucus production, and improve muco-ciliary transport. As such, MEDI3506 is hypothesised to impact asthma disease status by increasing forced expiratory volume in the first second (FEV1, and other physiological measures of lung function) and reducing frequency and severity of asthma exacerbations, thereby improving quality of life. This Phase II study aims to assess the efficacy and safety of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.
Participants will be randomised in a 1:1:1 ratio to receive 600 mg MEDI3506, 300 mg MEDI3506, or placebo every 4 weeks (Q4W) by subcutaneous (SC) injection for a total of 4 doses.
Participants will be enrolled in this study for up to 29 weeks. The study comprises of 3 periods including the screening period of up to 5 weeks, an intervention period of 16 weeks, and a follow-up period of 8 weeks.REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0400
Date of REC Opinion
1 Jul 2021
REC opinion
Further Information Favourable Opinion