| CTRI Number |
CTRI/2024/12/078555 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
A Phase III Open-Label Extension Study To Evaluate The Long-Term Safety Of Astegolimab In Patients With Chronic Obstructive Pulmonary Disease |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| GB43374_Protocol V1 (India) dated 01Nov 2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
102-A Wing Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East 101-A Wing Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East,
Mumbai
MAHARASHTRA
400099
India |
| Phone |
02266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppd.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head- Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, 101, A Wing, Fulcrum, Hiranandani Business Park, Sahar Road, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
912266022999 |
| Email |
Rashmi.Chitgupi@ppd.com |
|
|
Source of Monetary or Material Support
|
| F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
F. Hoffmann-La Roche Ltd |
| Address |
Grenzacherstrasse 124 4070 Basel, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
Argentina
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czech Republic
Denmark
France
Germany
Hong Kong
Israel
Kenya
Mexico
Netherlands
New Zealand
Peru
Philippines
Poland
Republic of Korea
Romania
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
United Kingdom
United States of America
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhat Ranjan Sinha |
Aakash Healthcare SuperSpecialty Hospital |
Hospital Plot, Road No.-201,Sector-3, Dwarka, -110075,India
New Delhi
New Delhi
DELHI |
01143388888
drprabhat.ranjan@aakashhealthcare.com |
| Dr Sandeep Katiyar |
Apollo Speciality Hospital Pvt. LTd |
14/138, Chunni Ganj,Kanpur-208001, UttarPradesh, India
Kanpur Dehat
UTTAR PRADESH
Kanpur Dehat
UTTAR PRADESH |
9889888080
macrc03@gmail.com |
| Dr Manas Sen |
ESIC Medical College and Hospital |
Clinical Trial Unit MRU (Multidisciplinary Research Unit)
Basement ESIC Medical college & Hospital, NH3, NIT, Faridabad 121001, Haryana India
Faridabad
HARYANA |
9968306997
drmksen@yahoo.com |
| Dr Kirankumar Chandubhai Rami |
GMERS Medical College and Civil Hospital, Sola |
104-TB & Chest
Department,A
Block,OPD Buidling,
Gujarat high court, Sola
gram road
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
97232228665
drkiranrami117@gmail.com |
| Dr K Sunil Naik |
Government Medical College and Government General Hospital |
Department of Medicine Srikakulam Andra Pradesh-532001 India
Srikakulam
ANDHRA PRADESH |
944082899
drsunilnaikggh@gmail.com |
| Dr Jotideb Mukhopadhyay |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of
Medicine, 4th Floor,
244, A.J.C Bose Road,
700020, India.
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9433770356
drjotideb60@gmail.com |
| Dr Piyush Arora |
Jawahar Lal Nehru Medical College |
Clinical Research
Department Jawahar
Lal Nehru Medical
College Kala Bagh
305001
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN |
9887088122
Doctor.piyusharora@gmail.com |
| Dr Mohammad Shameem |
Jawaharlal Nehru Medical College |
Department of Tuberculosisand Chest Disease,Jawaharlal Nehru MedicalCollege, AligarhMuslimUniversity, Aligarh,Uttar Pradesh 202002, India.
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9412731835
mshameen@myamc.ac.in |
| Dr Ram S Kaulgud |
Karnataka Medical College and Research Institute |
Hubballi P.B Road, Vidyanagar, Hubballi-580021, Dharwad Dist. Karnataka state, India
Dharwad
KARNATAKA |
08362373348
ramkaulgud@gmail.com |
| Dr Himanshu Pophale |
Kothrud Hospital |
Opp. Hill View Park,
(Metro Car Depot),
Paud Road, Kothrud,
Pune, Maharashtra
411038, India.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9503939461
himanshupophale@yahoo.co.in |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Central Spine, AgrasenAspatal Marg, Sector - 7,Vidhyadhar Nagar- 302039,India
Jaipur
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Sandeep Kumar Gupta |
MV Hospital and Research Centre |
314/30 Mirza Mandi Chowk, -226003, India
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9336077839
sandeepkumar.gupta@rediffmail.com |
| Dr Boyilla Nagaraju |
Paarthiv LungCare Center |
Plot No. 2, Czech colony,road no.1 Hyderabad500018,Telangana state, India
Hyderabad
Hyderabad
TELANGANA |
8886863444
drnagaraj.b@gmail.com |
| Dr Akash Balki |
Shree Hospital & critical Care Centre |
3rd Floor Behind Shree Hospital & Critical Care Centre, Mirchi Bazaar, Umrer Road, Sakkardara,Sq,Nagpur-440009,
Nagpur
MAHARASHTRA |
9890812215
Akashbalki49@gmail.com |
| Dr Ajit Singh |
SMS Medical college and attached Hospitals |
Room No. 16 First Floor
Division of Allergy &
Pulmonary Medicine
Dhanvantri OPD
Block,SMS
Hospital,JLN Marg
Jaipur
Jaipur
RAJASTHAN |
09829135692
dr.ajeetsingh@yahoo.com |
| Dr Venkata Nagarjuna Maturu |
Yashoda Hospitals |
Hitech City, Cyber Towers to JNTU Road, -500084, India
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9100935638
arjunjipmer@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Aakash Healthcare Super Specialty Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Apollo Specialty Hospital Kanpur Ethics Committee |
Approved |
| IEC,MaharajaAgrasenHospital |
Approved |
| Institutional Ethics Committe -Yashoda Academy of Medical Education and Research |
Approved |
| Institutional Ethics Committee for ESIC Faridabad |
Approved |
| Institutional Ethics Committee for M. V. Hospital and Research Centre |
Approved |
| Institutional Ethics committee for Research involving Human subject IPGME &R Research Oversight Committee |
Submittted/Under Review |
| Institutional Ethics committee GMERS Medical College & Civil Hospital, Sola |
Submittted/Under Review |
| Institutional Ethics Committee Jawahar Lal Nehru Medical College Kala Bagh, |
Approved |
| Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital |
Approved |
| Institutional Ethics Committee Karnataka institute of medical sciences |
Approved |
| Institutional Ethics Committee S.M.S. Medical College and attached Hospitals |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital, |
Submittted/Under Review |
| Institutional Ethics committee- Neelima Hospitals |
Approved |
| Royal Pune Independent EthicsCommittee |
Approved |
| Shree Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Astegolimab(RO7187807) |
Dose: Astegolimab 476 mg
Route Of Administration: Subcutaneous injection.
Eligible participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study.
Total duration: 220weeks
|
| Comparator Agent |
NA |
NA |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients must meet the following criteria for study entry:
1.Signed Informed Consent Form
2.Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment
3.Completion of the 52-week treatment period in either Study GB43311 or Study GB44332
Participants with missing Week 52 visit assessments will not meet this eligibility criteria and cannot be enrolled in the GB43374 open-label extension study until Week 52 assessments are completed. For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.
4.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab.
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
|
|
| ExclusionCriteria |
| Details |
Patients who meet any of the following criteria will be excluded from study entry:
1.Withdrawal of consent and/or premature discontinuation from parent study
2.Any permanent discontinuation of study drug in parent study
3.Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigators judgment
4.Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug.
5.Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
6.Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
7.Active tuberculosis or untreated latent tuberculosis
If a patient is positive for latent tuberculosis at screening, they can be eligible after completing treatment per local standard of care.
8.Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and or anti-IL-5 therapies) at the time of study entry
9.Initiation of treatment that is considered palliative (e.g., for life expectancy less than 12 months) since enrolling in the parent study
10.History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab
11. Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the patients safe participation in and completion of the study since enrolling in the parent study
12. Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
13.Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study
14.QT interval corrected through use of Fredericias formula (QTcF) greater than 450ms if patient is male of QTcF greater than 470ms if patient is female
15.For male or female patients with QRS greater than 120ms- QTcF greater than 480ms.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the long-term safety of Astegolimab
|
The assessment will be carried out while comparing to baseline visit (participant who have received at least 1 dose of study drug is eligible for the analysis) based on the Incidence and severity of all AEs, SAEs, AESIs and AEs leading to death or Discontinuation Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric AEs (DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Phase III multicenter, open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab in combination with standard of care (SOC). Patients with COPD who have completed the 52-week treatment period in either Study GB43311 or Study GB44332 and fulfill the eligibility criteria for the OLE will be enrolled. Patients who have discontinued treatment in either parent study will not be eligible to enroll into the OLE. Several key aspects of the study design and study population are summarized below. Astegolimab 476 mg will be administered Q2W by subcutaneous injection. All participants must continue to be on optimized, stable COPD maintenance therapy, with no anticipated changes in therapy throughout the study The total duration of study participation for each individual is expected is expected to range from 1 day to more than 51 months The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in either the Phase IIb (GB43311) or Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs). |