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Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

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ClinicalTrials.gov Identifier: NCT04072887
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this study is to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in COPD patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple combination therapy of LABA, LAMA and ICS with respect to trough FEV1 change from baseline after 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: QBW251 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 956 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : January 13, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: QBW251 450 mg
QBW251 450 mg
 Drug: QBW251
QBW251 b.i.d
Active Comparator: QBW251 300 mg
QBW251 300 mg
 Drug: QBW251
QBW251 b.i.d
Active Comparator: QBW251 150 mg
QBW251 150 mg
 Drug: QBW251
QBW251 b.i.d
Active Comparator: QBW251 75 mg
QBW251 75 mg
 Drug: QBW251
QBW251 b.i.d
Active Comparator: QBW251 25 mg
QBW251 25 mg
 Drug: QBW251
QBW251 b.i.d
Placebo Comparator: QBW251 Placebo
QBW251 Placebo
 Drug: Placebo
Placebo b.i.d


Outcome Measures
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Primary Outcome Measures :
  1. Trough FEV1 [ Time Frame: 12 weeks ]
    Trough FEV1 change from baseline after 12 weeks of treatment


Secondary Outcome Measures :
  1. Overall COPD symptoms, cough and sputum [ Time Frame: Baseline, 12 and 24 weeks ]
    Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS) weekly mean scores (total and subscale scores).

  2. Overall COPD symptoms, cough and sputum [ Time Frame: Baseline, 12 and 24 weeks ]
    Change from baseline in Patient Global Impression of Severity (PGI-S) score

  3. Overall COPD symptoms, cough and sputum [ Time Frame: Baseline, 12 and 24 weeks ]
    Change from baseline in the Cough and Sputum Assessment Questionnaire (CASA-Q) domain scores - cough symptoms, cough impact, sputum symptoms, and sputum impact.

  4. Health-related quality of life [ Time Frame: Baseline, 12 and 24 weeks ]
    Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total and domain scores at weeks 12 and 24.

  5. Lung function [ Time Frame: Baseline, 4, 8, 16, 20 and 24 weeks ]
    Trough FEV1 change from baseline after 4, 8, 16, 20 and 24 weeks of treatment, respectively

  6. Pharmacokinetics of QBW251 [ Time Frame: Up to 24 weeks ]
    Assessment of drug exposure (trough concentration) on all visits

  7. Pharmacokinetics of QBW251 [ Time Frame: Day 1, 15 and Week 24 ]
    Assessment of drug exposure around Cmax on Days 1, 15 and 169.

  8. Pharmacokinetics of QBW251 [ Time Frame: Day 1 and 15 ]
    Assessment of drug exposure, AUC on Days 1 and 15 in a subset of patients

  9. Pharmacokinetics of QBW251 [ Time Frame: Day 1 and 15 ]
    Assessment of drug exposure, Cmax on Days 1 and 15 in a subset of patients

  10. Pharmacokinetics of QBW251 [ Time Frame: Up to 24 weeks ]
    Assessment of drug exposure (Cmin) on all visits


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.
  • Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening.
  • Patients featuring chronic bronchitis

Exclusion Criteria:

  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization.
  • Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
  • Patients with a body mass index (BMI) of more than 40 kg/m2.
  • Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
  • Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation.
  • Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072887


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04072887    
Other Study ID Numbers: CQBW251B2201
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COPD
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive