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 (MEDI3506) in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations.

JRCT ID: jRCT2031220659

Registered date:23/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrollment: 06/03/2023
• Target sample size: 44
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,Hungary,Japan,India,Japan,Mexico,Japan,Netherlands,Japan,Norway,Japan,Portugal,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Turkey,Japan,US,Japan,Vietnam,Japan,Australia,Japan,Brazill,Japan,Chile,Japan,China,Japan,Columbia,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Peru,Japan
• Study type: Interventional

Intervention(s)

Arm
Experimental: Tozorakimab Dose 1
Injection subcutaneously Tozorakimab or placebo via pre-filled syringe.
Intervention/treatment
Combination Product: Tozorakimab
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study.

Arm
Experimental: Tozorakimab Dose 2
Injection subcutaneously Tozorakimab via pre-filled syringe.
Intervention/treatment
Combination Product: Tozorakimab
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study.

Arm
Placebo Comparator: Placebo
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
Intervention/treatment
Combination Product: Placebo
Participants previously randomised to placebo in one of the predecessor studies will be reassigned to one of the active doses of Tozorakimab or placebo in a 1:1:2 ratio.

Outcome(s)

• Primary Outcome: Time to first severe COPD exacerbation in former smokers.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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 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.

Exclude 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 makes 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 study or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.

4 Known history of:

a. Severe allergic reaction to any monoclonal and polyclonal antibody.

b. 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.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT05742802