CTRI/2025/11/098057 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On:
19/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Other
Public Title of Study
A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD
Scientific Title of Study
A Phase 2b Randomized, Double blind, Placebo controlled, Parallel Group Study to Assess Efficacy and Safety of Verekitug UPB-101 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease COPD
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Details of Contact Person Scientific Query
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Details of Contact Person Public Query
Name
Dr Annappa Kamath
Designation
Executive Director Project Leadership
Affiliation
Parexel International Clinical Research Private Limited
Address
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Bangalore KARNATAKA 560103 India
Phone
919902096914
Fax
918067723001
Email
Annappa.Kamath@parexel.com
Source of Monetary or Material Support
Upstream Bio Inc.
890 Winter Street, Suite 200,
Waltham, MA 02451, USA
Primary Sponsor
Name
Upstream Bio Inc.
Address
890 Winter Street, Suite 200,Waltham, MA 02451, USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Parexel International Clinical Research Private Limited
CoWrks, RMZ EcoWorld, Ground Floor, Bay Area – Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village, BENGALURU – 560103, Karnataka, INDIA
Countries of Recruitment
Argentina Bulgaria Chile Czech Republic Georgia Germany Hungary India Ireland Latvia Lithuania Malaysia Mexico Philippines Poland Republic of Korea Romania Serbia Slovakia South Africa Spain Taiwan Thailand Turkey Ukraine United Kingdom United States of America Viet Nam
Department of Pulmonary Medicine-Room no 2, Ground floor, Clinical Research unit, Darga Mitta, G.T. Road, Nellore -524 004, Andhra Pradesh, India Nellore ANDHRA PRADESH
08612316299
draparnaacsrgmc@gmail.com
Dr Boyilla Nagaraju
Aster Prime Hospitals
Department of Pulmonology, beside wellness center, basement room 1, Clinical Research unit.
Opp Passport Seva Kendra, Ameerpet, Hyderabad-500038, Telangana, India. Hyderabad TELANGANA
04049594959
nagaraj.boyilla@gmail.com
Dr Vasireddy Aruna
Govt. Siddhartha Medical College
Department of Pulmonary Medicine- Room 201,1st floor, Clinical research unit Ring Road, Gunadala, Vijayawada – 520 008, Andhra Pradesh, India Krishna ANDHRA PRADESH
91 8662450390
vasireddyaruna@rediffmail.com
Dr Piyush Arora
Jawahar Lal Nehru Medical College
Department of Respiratory-Room no. 06, Clinical Research unit Kal Bagh, Ajmer-305001, Rajasthan, India Ajmer RAJASTHAN
01452431842
doctor.piyusharora@gmail.com
Dr Ankit Kumar
King Georges Medical University
Department of Respiratory-Ground floor, Room no 505 5th floor Clinical research unit Medicine, Shahmina Road, Chowk, Lucknow, Uttar Pradesh - 226003 India Lucknow UTTAR PRADESH
919305015816
ankyaar@kgmcindia.edu
Dr Randeep Guleria
Medanta The Medicity
Department of Internal Medicine and Respiratory and Sleep Medicine-Room no 17,4th floor OPD, Clinical Research unit Sector-38, Gurugram - 122001, Haryana, India Gurgaon HARYANA
01244141414
Randeep.Guleria@Medanta.org
Dr Jaydip Deb
Nil Ratan Sircar Medical College & Hospital
Department of Pulmonology- Room no12 Basement, Clinical Research unit,138, AJC Bose Road, Kolkata-700014 West Bengal, India Kolkata WEST BENGAL
2265 3333
jaydip.deb@gmail.com
Dr Pawan Kumar Singh
Pt BD Sharma Post Graduate Institute of Medical Sciences
Department of Pulmonary and Critical Care Medicine, room no 17, Clinical Research unit - Near Delhi Bye Pass, Rohtak-124001, Haryana, India Rohtak HARYANA
01262281308
ga.ps.complete@gmail.com
Dr Saibannavar Anita Ajit
Rajarshee Chhatrapati Shahu Maharaj Government Medical College & Chhatrapati Pramila Raje Hospital
Department of Pulmonology- Room 7, Clinical Research unit Dasara Chowk, Bhausinghaji road, Town Hall, Kolhapur-416012, Maharashtra, India Kolhapur MAHARASHTRA
02312991534
rcsmgmc.research@gmail.com
Dr Rajendra Saugat
S.P. Medical College & A.G. of Hospitals
Department of Respiratory Medicine, Clinical Research Unit-room 1 and 2, Near Medicine ICU & Maharaja MRI, Bikaner 334001, Rajasthan, India Bikaner RAJASTHAN
01512220115
rajendrasaugat1@gmail.com
Dr Akash Balki Lataru
Shree Hospital & Critical Care Centre799
Department of Respiratory Medicine,3rd Floor 786-A, Clinical Research unit, Om Nagar Opp Tajshree Building,
Sakkardara Sq Nagpur 440009, Maharashtra, India
Nagpur MAHARASHTRA
07122702215
akashbalki49@gmail.com
Dr Jagdish Kumar Rawat
Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital
Department of Respiratory Medicine ground floor, OPD 1 south block, Clinical research unit- Patel Nagar, Dehradun -248001,Uttarakhand, India Dehradun UTTARANCHAL
135245521
drjagdishrawat@yahoo.com
Dr Amit Dhamija
Sir Ganga Ram Hospital
Department of Chest Medicine,3rd floor, room no:1309, Clinical Research unit. SGRH Marg, Rajinder Nagar, New Delhi-110060, India New Delhi DELHI
Institutional Ethics Committee Pt BD Sharma Post Graduate Institute of Medical Sciences UHS Rohtak 124001 Haryana India
Submittted/Under Review
Ethics committee Aster Prime Hospitals Behind mythrivanam, Beside Blue fox Hotel, Ameerpet, Hyderabad-500038, Telangana, India
Approved
Ethics Committee NRS Medical College NRS Medical College And Hospital,138, AJC Bose Road Kolkata 700014, West Bengal India
Submittted/Under Review
Ethics Committee Sir Ganga Ram Hospital, SGRH Marg Rajinder Nagar, New Delhi 110060, India
Submittted/Under Review
Ethics committee SP Medical College, SP Medical College, Bikaner Pawanpuri, Bikaner Rajasthan 334003 India
Approved
Institutional Ethics Committee Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan 305001, India
Approved
Institutional Ethics Committee, Admin Block, Shri Guru Ram Rai Institute of Medical and Health Sciences And Shri Mahant Indiresh Hospital, Patel Nagar, Dehradun 248001 India
Approved
Institutional Ethics Committee, King Georges Medical University, Shahmina Road, Chowk, Lucknow, Uttar Pradesh 226003, India
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE, NELLORE, AC Subba Reddy Govt Medical College and Hospital, Opp AC Stadium, Dargamitta, GT Road, Nellore 524004 Andhra Pradesh India
Submittted/Under Review
Institutional Ethics Committee, SMC & GGH, Govt. Siddhartha Medical College, Ring Road, Gunadala, Vijayawada – 520008, Andhra Pradesh, India
Approved
Medanta Institutional Ethics Committee MIEC ,10th Floor, A wing POCU, Medanta The Medicity, Sector-38, Gurugram 122001, Haryana, India
Approved
RCSMGMCIEC2, RCSMGMC and CPR Hospital, Building No. 2, Quarter no. 3, Room no. 7, Dasara Chowk, Bhausinghaji Road, Town Hall, Kolhapur- 416012, Maharashtra, India
Approved
Shree Hospital Ethics Committee Shree Hospital Unit, Plot No.786 A,3rd Floor Behind Shree Hospital & Critical Care Centre, Mirchi Bazaar, Umrer Road, Sakkardara, Sq,Nagpur-440009, Maharashtra, India
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Matching Placebo to Verekitug (UPB-101)
Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
Intervention
Verekitug (UPB-101)
Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
Intervention
Verekitug (UPB-101)
Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug [UPB-101]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.
Age greater than or equal to 40 to less than or equal to 85 years at the time of signing the informed consent.
1. Physician diagnosis of COPD for greater than 12 months.
2. Current or former smokers with a smoking history of 10 pack years or more.
3. Post-bronchodilator FEV1 Forced Vital Capacity FVC ratio less than 0.70 and predicted post bronchodilator FEV1 greater than 30 percent and less than or equal to 80 percent.
4. Modified Medical Research Council dyspnea scale Grade greater or equal to 2.
5. Background triple therapy Inhaled Corticosteroid ICS, Long-Acting Beta Agonist LABA, Long-Acting Muscarinic Antagonist LAMA for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit 1. If ICS is contraindicated, double therapy with LABA and LAMA are allowed as per investigator discretion.
6. Are greater than or equal to 80 percent compliant with background therapy during the screening period.
ExclusionCriteria
Details
1. Moderate or severe exacerbation of COPD within 4 weeks prior to or during the screening period.
2. Respiratory tract infection within 4 weeks prior to or during the screening period.
3. Treatment with oxygen of greater than 4 liters per minute. Nocturnal oxygen use for sleep apnea is allowed.
4. Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1.
Note: Participants must not discontinue any medical treatment solely for the purpose of making a participant eligible for study participation.
5. Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines
6. History or evidence of a clinically meaningful pulmonary condition other than COPD e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
7. Chronic hypercapnia requiring Bilevel Positive Airway Pressure BiPAP. Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded.
8. Any of the following in the previous 6 months prior to Visit 1: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis and cardiac arrhythmia including paroxysmal e.g. intermittent.
Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy i.e. selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Annualized rate of moderate or severe COPD exacerbation events
Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)
From Day 1 (Baseline) to Week 60
Annualized rate of severe COPD exacerbation events
From Day 1 (Baseline) up to Week 108
Change in St Georges Respiratory Questionnaire (SGRQ) total score
From Day 1 (Baseline) to Week 60
Proportion of participants with SGRQ improvement of greater than 4 points
At Week 60
Incidence of treatment emergent adverse events & serious adverse events graded by Common Terminology Criteria for Adverse Events version 5.0
From Day 1 (Baseline) up to Week 112
Target Sample Size
Total Sample Size="666" Sample Size from India="40" 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 2
Date of First Enrollment (India)
27/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
02/07/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="5" 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 global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD. Adult participants are planned to be enrolled and will be allocated randomly in a 1:1:1 ratio to one of two dose levels of verekitug or placebo, in addition to their COPD background medications. The study consists of a screening period of approximately 4 weeks; treatment periods of between 60 weeks and up to 108 weeks; and a follow-up period, with the end-of-study visit 16 weeks after last dose.