Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma

NCT04049175 | Terminated Phase 3 DMC

• 2 other identifiers: CLI-06532AA1-012018-003548-22
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase III Study is to demonstrate the efficacy of at least one dose of CHF 6532 on moderate and severe asthma exacerbations rate compared to placebo.

Conditions

Asthma; Eosinophilic

Outcome Measures

Primary Outcomes (1)

• Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate

  Rate of moderate and severe asthma exacerbations during the treatment period with CH 6532 (3 doses tested) or Placebo

  Over 52 weeks of treatment

Secondary Outcomes (9)

• Effect of CHF 6532 on severe asthma exacerbations compared to Placebo

  Over 52 weeks of treatment

• Effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning FEV1 (Forced Expiratory Volume in 1 second)

  At Week 52

• Effect of CHF 6532 compared to Placebo in terms of change from baseline on St. George's Respiratory Questionnaire (SGRQ)

  At Week 52

• Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Control Questionnaire (ACQ-5)

  At Week 52

• Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Quality of Life Questionnaire (AQLQ+12)

  At Week 52

Study Arms (4)

Treatment A

EXPERIMENTAL

Administration of CHF 6532 Dose #1

Drug: Treatment A

Treatment B

EXPERIMENTAL

Administration of CHF 6532 Dose #2

Drug: Treatment B

Treatment C

EXPERIMENTAL

Administration of CHF 6532 Dose #3

Drug: Treatment C

Treatment D

PLACEBO COMPARATOR

Administration of CHF 6532 Placebo

Drug: Treatment D

Interventions

Treatment A DRUG

Tablet of CHF 6532

Also known as: CHF 6532

Treatment A

Treatment B DRUG

Tablet of CHF 6532

Also known as: CHF 6532

Treatment B

Treatment C DRUG

Tablet of CHF 6532

Also known as: CHF 6532

Treatment C

Treatment D DRUG

Tablet of CHF 6532 placebo

Also known as: CHF 6532

Treatment D

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥12 years and ≤75 years with a diagnosis of asthma \[according to Global Initiative for Asthma (GINA)\] for a period of at least 24 months prior to screening.
• Subjects treated according to GINA step 4/5 with stable high-dose inhaled corticosteroids (ICS) plus a long-acting β2 agonist (LABA)
• Asthma exacerbations history.
• A positive response to a reversibility test at screening.
• Subjects with evidenced eosinophilic airway inflammation at screening visit.
• Subjects with uncontrolled asthma as evidenced by ACQ-5 score ≥1.5 at screening and randomisation visits.
• Subjects with co-operative attitude and ability to perform all trial related procedures.
• Ability of patient to swallow tablets.

You may not qualify if:

• Pregnant or lactating women and all women of childbearing potential unless are using a highly effective birth control method.
• Run-in compliance \< 50% at randomisation
• Hospitalisation, emergency room admission or use of systemic corticosteroids for an asthma exacerbation or respiratory tract infection in the 4 weeks prior to screening visit or during the run-in period.
• Subjects with a history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit which, in the judgement of the investigator, may place the subjects at undue risk.
• Subjects with a history of more than 2 episodes of confirmed bacterial lower respiratory tract infection within the year prior to screening or with a bacterial lower respiratory tract infection during the run-in.
• History of diagnosis of Chronic Obstructive Pulmonary Disease (COPD), cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
• Subjects with a marked resting baseline prolongation of mean QTc interval.
• Subjects with a family history of long QT Syndrome.
• Subjects with hypokalemia at screening.
• Subjects who have known clinically significant cardiovascular conditions.
• Subjects with a history of symptoms or significant neurological disease.
• Subjects with clinically significant abnormal serum biochemistry, haematology (not associated with the study indication) at screening according to the investigators judgement.
• Current smokers or ex-smokers with total cumulative exposure ≥10 pack-years or having stopped smoking less than one year prior to screening visit.
• Subjects with historical or current evidence of uncontrolled concurrent disease.
• Subjects with a history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Medical Center "Nov Rehabilitatsionen Tsentar" Ltd

Stara Zagora, 6000, Bulgaria

Location

Related Links

• Study Record on EU Clinical Trials Register including results
• Lay Summaries of study results available in the CHIESI Clinical Study Register

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pierluigi Paggiaro, MD

  Universita di Pisa, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: August 28, 2019
• Primary Completion: October 19, 2020
• Study Completion: February 1, 2021
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)