Clinical trial NCT05742802: Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
Official title: A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Tozorakimab
MEDI3506
exacerbations
ICS
LABA/LAMA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-02-24
Enrollment: 1869
Sex: ALL
Minimum age (years): 40
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

Detailed description: Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations

Eligibility criteria: Inclusion Criteria:

1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
4. Known history of:

   1. Severe allergic reaction to any monoclonal and polyclonal antibody.
   2. Allergy or reaction to any component of the IP formulation.
5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Primary outcomes:
measure: Annualised rate of severe COPD exacerbations in former smokers.
timeFrame: Up to 104 weeks.
Secondary outcomes:
measure: The annualised rate of severe COPD exacerbations
timeFrame: Up to 104 weeks.
measure: Time to First Severe COPD Exacerbations
timeFrame: Up to 104 weeks.
measure: Time to first moderate-to-severe COPD exacerbation.
timeFrame: Up to 104 weeks.
measure: Annualised rate of moderate to severe COPD exacerbations.
timeFrame: Up to 104 weeks.
measure: Time to all-cause death.
timeFrame: Up to 104 weeks.
measure: Trough serum concentrations of tozorakimab over the treatment period.
timeFrame: Up to 104 weeks.
measure: Incidence of anti-drug antibodies.
timeFrame: Up to 104 weeks.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Sheffield
country: United States
facility: Research Site
state: Alabama
city: Tempe
country: United States
facility: Research Site
state: Arizona
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Lincoln
country: United States
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state: California
city: Newport Beach
country: United States
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state: California
city: Northridge
country: United States
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state: California
city: Boynton Beach
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state: Florida
city: Cape Coral
country: United States
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city: Ormond Beach
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city: Pensacola
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city: Plantation
country: United States
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city: Tampa
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city: Winter Park
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city: Normal
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city: Farmington Hills
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city: Grand Rapids
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country: Argentina
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country: Argentina
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Brazil
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country: Brazil
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country: Brazil
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country: Bulgaria
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city: Kozloduy
country: Bulgaria
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country: Bulgaria
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country: Canada
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country: Chile
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Shenzhen
country: China
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country: China
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city: Suzhou
country: China
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country: China
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city: Tianjin
country: China
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city: Wuhan
country: China
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city: Wuxi
country: China
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city: Xiamen
country: China
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city: Xuzhou
country: China
facility: Research Site
city: Xuzhou
country: China
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city: Yangzhou
country: China
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country: China
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city: Zhanjiang
country: China
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city: Zunyi
country: China
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city: Barranquilla
country: Colombia
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city: Ibague
country: Colombia
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city: Zipaquira
country: Colombia
facility: Research Site
city: Brno
country: Czechia
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city: Broumov
country: Czechia
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city: Jihlava
country: Czechia
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city: Jindrichuv Hradec
country: Czechia
facility: Research Site
city: Liberec 1
country: Czechia
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country: Czechia
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city: Rokycany
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city: Copenhagen
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Naestved
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
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city: Vejle
country: Denmark
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city: Ålborg
country: Denmark
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city: Helsinki
country: Finland
facility: Research Site
city: Hämeenlinna
country: Finland
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city: Kuopio
country: Finland
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city: Tampere
country: Finland
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city: Turku
country: Finland
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city: Bordeaux
country: France
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city: Brest Cedex
country: France
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country: France
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country: France
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city: Limoges
country: France
facility: Research Site
city: Lyon Cedex 04
country: France
facility: Research Site
city: MARSEILLE cedex 15
country: France
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city: Montpellier Cedex 5
country: France
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city: Nantes
country: France
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city: Toulouse
country: France
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city: Ahrensburg
country: Germany
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city: Bamberg
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Darmstadt
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: München-Pasing
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Peine
country: Germany
facility: Research Site
city: Alexandroupolis
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Exohi Thessaloniki
country: Greece
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city: Ioannina
country: Greece
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city: Patras
country: Greece
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city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Edelény
country: Hungary
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city: Encs
country: Hungary
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city: Gyöngyös
country: Hungary
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city: Mosonmagyaróvár
country: Hungary
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city: Nyíregyháza-Sóstóhegy
country: Hungary
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city: Százhalombatta
country: Hungary
facility: Research Site
city: Belagavi
country: India
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city: Coimbatore
country: India
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country: India
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country: India
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country: India
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country: India
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country: India
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country: India
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country: Israel
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country: Israel
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country: Israel
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country: Israel
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country: Israel
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city: Tel Aviv
country: Israel
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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city: Statte
country: Italy
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country: Italy
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country: Japan
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country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmö
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Yunlin
country: Taiwan
facility: Research Site
city: Bang Kra So
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Muang,
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Mueang
country: Thailand
facility: Research Site
city: Nakhon Ratchasima
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Enfield
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Preston
country: United Kingdom
facility: Research Site
city: Shipley
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
References: