Clinical trial • Phase IV • Respiratory

Tezepelumab for Chronic obstructive pulmonary disease

Phase IV trial of Tezepelumab for Chronic obstructive pulmonary disease.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Chronic obstructive pulmonary disease
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody|Other

Key dates

Initial CTIS Submission Date
25-04-2024
First CTIS Authorization Date
08-05-2024

Trial design

Randomised, placebo (solution for injection, subcutaneous). dose/schedule not specified-controlled Phase IV trial across 1 site in Denmark.

Randomised
Yes
Comparator
PLACEBO (solution for injection, subcutaneous). Dose/schedule not specified
Target Sample Size
40
Trial Duration For Participant
140

Eligibility

Recruits 40 adults.

Inclusion criteria

  • {"criterion_text":"- Subjects with COPD on LABA+LAMA±ICS with ≥ 1 exacerbation the past 12 months"}
  • {"criterion_text":"- Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and < 80% predicted"}
  • {"criterion_text":"- Age 40 years or older"}

Exclusion criteria

  • {"criterion_text":"- Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1 or during the run-in period"}
  • {"criterion_text":"- Any use of home oxygen therapy"}
  • {"criterion_text":"- Lung volume reduction surgery for COPD"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20","definition_or_measurement_approach":"Eosinophil cell counts per mm2 in bronchial mucosal tissue measured at baseline and at week 20, change expressed as a ratio"}

Recruitment

Planned Sample Size
40
Recruitment Window Months
42
Consent Approach
Informed consent form and subject information documents are listed in the trial dossier; specific details on consent/assent procedures, age-specific documents, and languages are not specified in the available record.

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Denmark

Earliest CTIS Part Ii Submission Date
01-05-2024
Latest Decision Or Authorization Date
02-10-2024
Processing Time Days
154
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Respiratory Research unit, Bispebjerg Hospital
Department Name
Department of Respiratory Medicine and Infectious Diseases, research unit
Principal Investigator Name
Asger Sverrild
Principal Investigator Email
asger.sverrild@regionh.dk
Contact Person Name
Asger Sverrild
Contact Person Email
asger.sverrild@regionh.dk
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Region Hovedstaden
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 14","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
TEZEPELUMAB
Active Substance
Tezepelumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Maximum Dose
210 mg daily; max total 1050 mg
Investigational Product Name
PLACEBO
Active Substance
Placebo
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION

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