CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
MEDI3506 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04570657
NCT04570657Phase 2Completed

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

AstraZeneca·interventional·Posted Sep 30, 2020·Updated Jan 30, 2024

In Brief

A Phase 2 clinical trial evaluating MEDI3506 and Placebo for Asthma. Completed, enrolled 250 participants across 65 sites in 7 countries.

Detailed Summary

Study D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Germany, Hungary, Poland, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 30, 2020
Enrollment StartSep 17, 2020
Primary CompletionDec 12, 2022
Study CompletionFeb 6, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.8 years ago

Interventions

MEDI3506biological

Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2

Placebodrug

Participants will receive multiple doses of placebo