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Icenticaftor Dose-finding Study in COPD
NCT04072887Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2019
- Primary completion
- Oct 2021
- Countries
- 26
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- Icenticaftor
- Conditions
- chronic obstructive pulmonary disease (COPD)chronic bronchitis (CB)
01
Overview
Phase 2, randomised, double-blind trial of Icenticaftor in chronic obstructive pulmonary disease (COPD) and chronic bronchitis (CB) (6 arms), sponsored by Novartis. Primary endpoint: Forced Expiratory Volume in One Second at 12 weeks. Started Sep 2019; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
QBW251 450 mg
Icenticaftor 450 mg b.i.d. + Background
QBW251 300 mg
Icenticaftor 300 mg b.i.d. + Background
QBW251 150 mg
Icenticaftor 150 mg b.i.d. + Background
QBW251 75 mg
Icenticaftor 75 mg b.i.d. + Background
QBW251 25 mg
Icenticaftor 25 mg b.i.d. + Background
Placebo
Placebo b.i.d. + Background
03
Endpoints
Primary
Forced Expiratory Volume in One Second
Secondary
Forced Expiratory Volume in One Second
Evaluating Respiratory Symptoms Total Score
Evaluating Respiratory Symptoms Cough and Sputum Score
Patient Global Impression of Severity
Cough and Sputum Assessment Questionnaire
St. George's Respiratory Questionnaire
Minimum Plasma Concentration
Maximum Plasma Concentration
04
Results
Not all primary endpoints met
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