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CTRI Number  CTRI/2023/05/052694 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 29/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease with a History of Exacerbations  
Scientific Title of Study   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) 
Trial Acronym  PROSPERO 
Secondary IDs if Any  
Secondary ID  Identifier 
D9180C00008, V 1.0 dated 09 Aug 2022_ NCT05742802  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Mr Tapankumar Shah 
Designation  Senior Director, Asia Area Cluster Head - Site Management & Monitoring 
Affiliation  AstraZeneca Pharma India Ltd. 
Address  AstraZeneca Pharma India Ltd. Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  8067748000  
Fax    
Email  Tapankumar.Shah@astrazeneca.com  
 
Details of Contact Person
Public Query  
Name  Mr Tapankumar Shah 
Designation  Senior Director, Asia Area Cluster Head - Site Management & Monitoring 
Affiliation  AstraZeneca Pharma India Ltd. 
Address  AstraZeneca Pharma India Ltd. Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore


KARNATAKA
560045
India 
Phone  8067748000  
Fax    
Email  Tapankumar.Shah@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca AB 151 85 Sodertalje, Sweden 
 
Primary Sponsor  
Name  AstraZeneca AB 151 85 Sodertalje, Sweden 
Address  AstraZeneca KK 3-1, Ofuka-cho, Kita-ku, Osaka, Japan 530-0011  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
AstraZeneca Pharma India Ltd  Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road, Bangalore – 560045, India  
 
Countries of Recruitment     Argentina
Australia
Belgium
Belize
Bulgaria
Canada
Chile
China
Colombia
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Norway
Peru
Philippines
Poland
Portugal
Republic of Korea
Romania
Spain
Sweden
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Kumar  Asthma Bhawan  Clinical Research Department Asthma Bhawan, R-3, Sector-6, Vidhyadhar Nagar, Jaipur-302039, Rajasthan, India
Jaipur
RAJASTHAN 		 9414454196

drashish19@gmail.com 
Dr Ajay Godse  Bhaktivedanta Hospital and Research Institute  Medical Research Department, Third floor, Bhaktivedanta Hospital and Research Institute Bhaktivedanta Swami Marg, Sector 1, Srishti Complex , Mira Road, Mira Bhayandar, Maharashtra 401107
Bhandara
MAHARASHTRA 		 9820452037

drajaygodse.research@gmail.com 
Dr Vivek Gupta  Criticare Hospital and Research Institute  Clinical Research Department, Criticare Hospital and Research Institute, 4th Floor, Dhanshree Complex, Near Hotel Hardeo, Sitabuldi, Nagpur, Maharashtra, India- 440012
Nagpur
MAHARASHTRA 		 9373115548

vivekurvashi@yahoo.co.in 
Dr Rajesh Swarnaker  GetWell Health & Research Institute  Department of Respiratory, Critical care and Sleep Medicine GetWell Health & Research Institute, 20/1, Dr. Khare Marg, Dhantoli, Nagpur-440012, Maharashtra, India
Nagpur
MAHARASHTRA 		 9822225130

pidrswarnakar@gmail.com 
Dr Srikanth Krishnamurthy  Hindusthan Hospital  Department of Pulmonology, 522/3, 523/3 Nava India Road, Udaiyampalayam, Coimbatore – 641028, Tamilnadu, India
Coimbatore
TAMIL NADU 		 9894257706

drsrikanthcbe@gmail.com 
Dr Jyothi Hattiholi  KLES Dr Prabhakar Kore Hospital & Medical Research Centre  Department of Pulmonary Medicine KLES Dr Prabhakar Kore Hospital & Medical Research Centre, Nehrunagar Belagavi-590010 Karnataka, India
Belgaum
KARNATAKA 		 7022799910

pulmojyoti@gmail.com 
Dr Jagdish Rawat  Shri Mahant Indiresh Hospital  Clinical Research Department, 4th floor Shri Mahant Indiresh Hospital, Patel Nagar, Dehradun, 248001 Uttarakhand
Dehradun
UTTARANCHAL 		 9639212630

drjagdishrawat@yahoo.com 
Dr Abhinandan Mutha  Siddhi Hospital  Clinical Research Department, Ground Floor Siddhi Hospital P-67, MIDC, Behind ITI, Trimbak Road, Near P.F. office, Satpur, Nashik- 422006
Nashik
MAHARASHTRA 		 9850767069

abhimutha@gmail.com 
Dr Rohit Kumar  VMMC & Safdarjung Hospital  Clinical Research Department, Room#662 VMMC & Safdarjung Hospital, Department of Pulmonary Critical Care and Sleep Medicine- PIN 110029
New Delhi
DELHI 		 9911218081

dr.rohitkumar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee Bhaktivedanta Hospital and Research   Approved 
Criticare Hospital and Research Institute Institutional Ethic Committee, Criticare Hospital and Research Institute  Approved 
Getwell Institutional Ethics Committee  Approved 
Institutional Ethics Committee Asthma Bhawan,   Approved 
Institutional Ethics Committee of VMMC and Safdarjung Hospital  Approved 
Institutional Ethics Committee, KAHER (Formerly known to be KLE University)  Approved 
Institutional Ethics Committee, Shri Guru Ram Rai Institute of Medical and Health Sciences  Approved 
Institutional Human Ethics Committee Hindusthan Hospital  Approved 
Siddhi Hospital Institutional Ethics Committee (SHIEC), C/O Mutha Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Placebo + Maintenance inhaled therapy (ICS/LABA/LAMA) 
Intervention  Tozorakimab  300 mg every 4 weeks + Maintenance inhaled therapy (ICS/LABA/LAMA) 
Intervention  Tozorakimab  300 mg every 8 weeks + Maintenance inhaled therapy (ICS/LABA/LAMA) 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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.
Reproduction
3 FOCBP must have a negative urine pregnancy test at Visit 1.
(a) For a definition of FOCBP, refer to Appendix E.
4 Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
(a) Male participants:
Non-sterile male participants who are sexually active with a FOCPB partner must
agree to use a male condom while engaging in sexual activity from enrolment throughout the study duration and until 14 weeks after last dose of IP. For a definition of non-sterile male, refer to Appendix E. In countries where spermicide is available, it is strongly recommended. It is also strongly recommended for the female partner of a male participant to use a highly effective method of contraception throughout this period.

Non-sterilised male patients should also refrain from biologically fathering a child or
donating sperm during the same period.
(b) Female participants:
FOCBP who are sexually active with a non-sterilised male partner must agree to use
one highly effective method of birth control, as defined below, from enrolment
throughout the study and until at least 14 weeks after last dose of IP. Cessation of
contraception after this point should be discussed with a responsible physician.
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal
(coitus interruptus), spermicides only, and lactational amenorrhoea method are not
acceptable methods of contraception. Female condom and male condom should not
be used together.
A highly effective method of contraception is defined as one that can achieve a
failure rate of less than 1% per year when used consistently and correctly. Highly
effective birth control methods can be found in Appendix E. It is highly
recommended for the male partner of a FOCBP participant to use a male condom
whilst engaging in sexual activity throughout this period.
Note that there are no contraception requirements for female participants who are not
of childbearing potential. However, all female participants should refrain from egg
cell donation and breastfeeding throughout the study.
Informed Consent
5 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
 
 
ExclusionCriteria 
Details  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 makes the participation of the participant inappropriate.
2 Participant meeting criteria for IP discontinuation refer to Section 7.1.1 as judged by the Investigator or the Sponsor.
Prior/Concomitant Clinical Study Experience
3 Concurrent enrolment in other interventional clinical study or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
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,
Other Exclusions
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, as judged by the Investigator or the Sponsor. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first severe COPD exacerbation in former smokers.  52 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first severe COPD exacerbation in former and current smokers  First severe COPD exacerbation - 52 weeks 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of severe COPD exacerbations.  Annualised rate of severe COPD exacerbations. - 52 weeks 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first moderate to severe COPD exacerbation.  Time to first moderate-to-severe COPD exacerbation. - 52 weeks 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.  Annualised rate of moderate to severe COPD exacerbations. - 52 weeks 
To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.  Time to all-cause death. - 52 weeks 
To evaluate the PK and immunogenicity of tozorakimab.  Trough serum concentrations of tozorakimab over the treatment
period. Incidence of anti-drug antibodies - 52 weeks 
To assess the long-term safety and tolerability of tozorakimab as an add on to SoC compared with SoC plus placebo.  week 52 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on measures of lung function.  Week 52 
To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on mucus plugging, airway structure and function, and emphysema
progression.
 		 Week 52 
To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on overall and COPD-related healthcare resource utilisation.  Week 52 
To evaluate the effect of tozorakimab as an add on to SoC compared with SoC plus placebo on time to respiratory-related death.  Week 52 
 
Target Sample Size   Total Sample Size="2544"
Sample Size from India="125" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/06/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  06/03/2023 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Phase III, multicentre, randomised, double-blind, chronic-dosing, parallel-group,

placebo-controlled extension study to evaluate the long-term efficacy and safety of

tozorakimab 300 mg Q4W and 300 mg Q8W administered SC, in participants with COPD with history of COPD exacerbations.

 

 

Eligible participants must have completed the treatment period and have not prematurely discontinued from IP in the predecessor studies and fulfil the inclusion/exclusion criteria. Participants will be encouraged to continue on the same stable COPD maintenance therapy throughout the study.

 

The primary and secondary objectives: 

To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first severe COPD exacerbation in former smokers.

To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the time to first severe COPD exacerbation in former and current smokers.

To evaluate the long-term effect of tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of severe COPD exacerbations.

 

 

 A total of 2544 participants will be randomized 1:1:1 to receive two dose regimen of Tozorakimab or placebo and includes:

      I.         Screening Period: Up to 2 to 12 weeks

a.      Treatment Period: 48-weeks double-blind treatment period with:

    II.          Study intervention administration (Tozorakimab or placebo) SC Q4W , Q8W from Week 0 to Week 48 for a total of 14 doses

Follow-up Period: Up to 12 weeks after last efficacy assessment at Week 52 (ie, 12 weeks after last dose of study intervention) 
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