AZD1419 Ph2a study - INCONTRO

Study identifier:D2500C00003

ClinicalTrials.gov identifier:NCT02898662

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 2 Placebo-Controlled, Randomized, Double Blind, Adaptive Dose Trial of the Safety and Efficacy of Inhaled AZD1419 in Adults With Eosinophilic, Moderate to Severe Asthma

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

Study drug

AZD1419, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 12 Oct 2016

Primary Completion Date: 25 Sept 2018

Study Completion Date: 25 Sept 2018

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2019 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Male and female patients 18 years and above
- Physician-diagnosed asthma requiring treatment with ICS and a long-acting beta agonist (LABA). Patients must have taken ICS plus LABA controller medication for at least 3 months prior to screening
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥50% predicted
- Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception
- Male patients must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) from the first dose of the IMP and until 1 month after the last dose of the IMP to prevent pregnancy in a partner
- Blood eosinophil levels ≥ 250 cells/μL at screening OR a history of blood eosinophil levels ≥ 250 cells/μL at any time in the preceding 2 years AND blood eosinophil levels ≥ 150 cells /μL at screening. The eosinophilia must be believed to be due to asthma and not have other known causes, e.g. helminth infection
- ACQ-5 score ≤1.5 at screening
- ACQ-5 score ≤0.75 at randomization
- Documentation of any of the following within 5 years prior to Visit 1:
• Proof of post-bronchodilator reversibility in FEV1 of ≥12% and ≥200 mL
• Proof of a positive response to a methacholine or histamine challenge (a decrease in FEV1 by 20% [PC20] at ≤8 mg/mL)
• Proof of positive response to mannitol challenge (a decrease in FEV1 by 15% [PD15] at ≤635 mg or a >10% decrease in FEV1 between consecutive doses)
• Proof of diurnal variability in PEF >20% over the course of 24 hours in at least
4 out of 7 consecutive days
If historical documentation is not available, proof of reversibility or a positive response to a methacholine, histamine or mannitol challenge or diurnal variation must be demonstrated according to above and documented during Visit 1

Exclusion Criteria

- Clinically significant lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis, active tuberculosis).
- History of autoimmune disease including but not limited to Wegener’s granulomatosis, system lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome, multiple sclerosis, autoimmune thrombocytopenia, primary biliary cirrhosis or any other autoimmune disease considered clinically relevant by the investigator
- Ongoing allergen immunotherapy or plans to begin such therapy during the study period
- DLco ≤ 60% of the lower limit of normal
- Breast feeding, pregnancy or intention to become pregnant during the course of the study
- Changes in chest X-ray suggesting clinically significant parenchymal disease other than asthma

No locations available

Arms	Assigned Interventions
Experimental: AZD1419 Dose adaption of AZD1419, 4 mg or 8 mg or 1 mg based on occurence of AE's	Drug: AZD1419 Inhaled AZD1419 administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events Other Name: NA
Placebo Comparator: Placebo Matching placebo	Drug: Placebo Inhaled Placebo administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is Placebo 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events Other Name: NA

Documents available

Protocol
Download
Statistical Analysis Plan (SAP)
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]