Effects of blocking TSLP on airway inflammation and the epithelial immune-response to exacerbation triggers in patients with COPD A randomized double-blind, placebo-controlled trial of Tezepelumab

2024-511730-12-00 Protocol ESR-21-21168 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 9 May 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol ESR-21-21168

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 80
Countries 1
Sites 1

Chronic obstructive pulmonary disease

To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation.

Key facts

Sponsor
Region Hovedstaden
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
9 May 2024 → ongoing
Decision date (initial)
2024-05-08
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-511730-12-00
EudraCT number
2022-000179-38
ClinicalTrials.gov
NCT05507242

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation.

Conditions and MedDRA coding

Chronic obstructive pulmonary disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Subjects with COPD on LABA+LAMA±ICS with ≥ 1 exacerbation the past 12 months
  2. Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and < 80% predicted
  3. Age 40 years or older

Exclusion criteria 3

  1. 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
  2. Any use of home oxygen therapy
  3. Lung volume reduction surgery for COPD

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Tezepelumab

SUB179650 · Substance

Active substance
Tezepelumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
210 mg milligram(s)
Max total dose
1050 mg milligram(s)
Max treatment duration
20 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo

SUB21402 · Substance

Active substance
Placebo
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
210 mg milligram(s)
Max total dose
1050 mg milligram(s)
Max treatment duration
20 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

38 Total trials 23 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Region Hovedstaden
Address
Bispebjerg Bakke 23
City
Copenhagen Nv
Postcode
2400
Country
Denmark

Scientific contact point

Organisation
Region Hovedstaden
Contact name
Asger Sverrild

Public contact point

Organisation
Region Hovedstaden
Contact name
Asger Sverrild

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark Code 14

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 40 1
Rest of world
United Kingdom
 — 40 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Respiratory Research unit, Bispebjerg Hospital
Department of Respiratory Medicine and Infectious Diseases, research unit, Ebba Lunds vej 48, indgang 66, Copenhagen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-05-09 2024-05-09

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol 3.0
Protocol (for publication) Protocol_tracked 3.0
Recruitment arrangements (for publication) Blank document 1
Subject information and informed consent form (for publication) Informed consent form 1.1
Subject information and informed consent form (for publication) Informed consent form_tracked 1.1
Subject information and informed consent form (for publication) Subject information 3.0
Subject information and informed consent form (for publication) Subject information_tracked 3.0
Summary of Product Characteristics (SmPC) (for publication) SmPC 1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-04-25 Denmark Acceptable
2024-05-07
 2024-05-08
2 SUBSTANTIAL MODIFICATION SM-3 2024-07-25 Denmark Acceptable
2024-09-26
 2024-10-02
3 SUBSTANTIAL MODIFICATION SM-5 2024-10-21 Denmark Acceptable
2024-11-01
 2024-11-01
4 NON SUBSTANTIAL MODIFICATION NSM-2 2026-02-02 Denmark Acceptable
2024-11-01
 2026-02-02

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