AZD1419 Ph2a Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02898662
• Date of registration: 16/08/2016
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: AZD1419 Ph2a Study INCONTRO
• Scientific 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
• Date of first enrolment: October 12, 2016
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02898662
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Denmark, Hungary, Poland, Sweden

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo

Drug: AZD1419

Primary Outcome(s)

Number of Participants With Events for Time to Loss of Asthma Control (LOAC) up to Week 52 - Cox Regression Analysis [Time Frame: Baseline (Week 0) up to Week 52]

Secondary Outcome(s)

Least Squares (LS) Mean ACQ-5 Score Over 52 Weeks [Time Frame: Baseline (Week 0) up to Week 52]

LS Mean Asthma Daily Diary Score (Weekly Total) Over 52 Weeks [Time Frame: Baseline (Week 0) up to Week 52]

LS Mean Total PEF (Weekly) Over 52 Weeks [Time Frame: Baseline (Week 0) up to Week 52]

LS Mean Pre- and Post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks [Time Frame: Baseline (Week 0) up to Week 52]

Number of Participants With Events for Time to Moderate Or Severe Exacerbation up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

Number of Participants Experiencing LOAC up to Week 52 - Generalized Estimating Equation Analysis [Time Frame: Baseline (Week 0) up to Week 52]

LS Mean Fractional Exhaled Nitric Oxide (FeNO) (Weekly) Over 52 Weeks [Time Frame: Baseline (Week 0) up to Week 52]

Percentage of Participants Using Reliever Medication up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

Secondary ID(s)

D2500C00003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02898662