Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Combination Product: Tozorakimab 1; Combination Product: Placebo; Combination Product: Tozorakimab 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT05742802

2022-501063-41-00 (Registry Identifier)

D9180C00008

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,596 estimated patients

Sex: All

Ages: 40 to 130 years old

Volunteers: No Healthy Volunteers

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 Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,596 participants in 3 patient groups, including a placebo group

Tozorakimab Dose 1

Experimental group

Description:

Injection subcutaneously Tozorakimab via pre-filled syringe.

Treatment:

Combination Product: Tozorakimab 1

Tozorakimab Dose 2

Experimental group

Description:

Injection subcutaneously Tozorakimab via pre-filled syringe.

Treatment:

Combination Product: Tozorakimab 2

Placebo

Placebo Comparator group

Description:

Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.

Treatment:

Combination Product: Placebo