| CTRI Number |
CTRI/2025/01/079061 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Phase 3 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria (EMBARQ-CSU2) |
|
Scientific Title of Study
|
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2024-513210-36-00 |
EudraCT |
| CDX0159-13 V1 29-Mar-2024 |
Protocol Number |
| IND: 140159 |
Other |
| NCT06445023 |
ClinicalTrials.gov |
|
|
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 |
Rashmi Chitgupi |
| Designation |
Country Head - Clinical Management |
| Affiliation |
PPD Pharmaceutical development Pvt Ltd. |
| Address |
101, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai
India
Mumbai
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Chitgupi |
| Designation |
Country Head - Clinical Management |
| Affiliation |
PPD Pharmaceutical development Pvt Ltd. |
| Address |
101, A Wing, Fulcrum Hiranandani Business Park, Andheri, Mumbai
India
MAHARASHTRA
400099
India |
| Phone |
912266022900 |
| Fax |
|
| Email |
rashmi.chitgupi@ppd.com |
|
|
Source of Monetary or Material Support
|
| Celldex Therapeutics, Inc.
53 Frontage Road, Suite 220
Hampton, NJ 08827 USA |
|
|
Primary Sponsor
|
| Name |
Celldex Therapeutics, Inc. |
| Address |
53 Frontage Road, Suite 220
Hampton, NJ 08827 USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
101 A Wing, Fulcrum, Hiranandani Business
Park, Sahar Road, Andheri East, Mumbai 400099, Maharashtra,
India |
|
|
Countries of Recruitment
|
Australia
Bulgaria
Canada
Chile
Colombia
Croatia
Georgia
Germany
Hungary
India
Italy
Lithuania
Mexico
Netherlands
Poland
Slovakia
Spain
Thailand
Tunisia
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandra Sirka |
All India Institute of Medical Sciences |
Sijua, Patrapada, Bhubaneswar- 751019
Khordha
ORISSA |
9438884055
dermat_chandra@aiimsbhubaneswar.edu.in |
| Dr Suneel Vartak |
Assured Care Plus Hospital |
4th & 5th Floor, Star Plus Complex, Lam Road, Near Muktidham Temple, Opp. NMC Divisional office, Nashik Road, Nashik-422101
Nashik
MAHARASHTRA |
0253950011
suneel.vartak@gmail.com |
| Dr Rima Joshi |
B J Medical College and Civil Hospital |
Department of Skin and VD, Asarwa, Ahmedabad-380016
Ahmadabad
GUJARAT |
9228585960
rimajoshi99@gmail.com |
| Dr Vinay Kulkarni |
Deenanath Mangeshkar Hospital & Research Centre |
Madhubhau Chaudhari Department of Dermatology and
Research Center, Main Building, 3rd Floor D wing, Erandwane, Pune-411004
Pune
MAHARASHTRA |
8605882649
vinay@prayaspune.org |
| Dr Rashmi Mahajan |
Dhiraj Hospital |
Sumandeep Vidyapeeth Deemed to be University, At and Po. Piraia, Ta, Waghodia, Vadodara-391760
Vadodara
GUJARAT |
9227676607
rsoodmahajan@mail.com |
| Dr Sakshi Midha |
Excelcare Hospital |
103, Sanjay Nagar-A, Joshi Marg, Kalwar Road, Jhotwara, Jaipur-302012
Jaipur
RAJASTHAN |
9001711113
sakshi.midha@gmail.com |
| Dr Dev Prakash Shivhare |
GSVM Medical College |
Department of Dermatology, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
9450136374
devprakash.80@gmail.com |
| Dr Nanjundaswamy BL |
K R Hospital attached to Mysore Medical College and Research Institute |
Department of Dermatology, Irwin Road, Mysuru-570001
Mysore
KARNATAKA |
9448025219
drblmswami@gmail.com |
| Dr Shivakumar Patil |
KLES Dr. Prabhakar Kore Hospital and Medical |
Research Centre, Nehru Nagar Belagavi – 590010
Belgaum
KARNATAKA |
9844512315
shivakumarkpatil@gmail.com |
| Dr Nipul Vara |
Medical College Baroda and SSG Hospital |
Jail Road, Indira Avenue, Vadodara- 390001
Vadodara
GUJARAT |
9426074084
nipulvara@yahoo.co.in |
| Dr Dipak Patel |
Nirmal Hospital Pvt Ltd |
Ring Road, Surat-395002,
Surat
GUJARAT |
9879573292
drdipakapatel@gmail.com |
| Dr Hemant Kumar Talnikar |
Oyster & Pearl Hospitals (Phadnis Clinic Pvt Ltd) |
167175, Ganeshkhind Road, Shivajinagar, Pune-411005
Pune
MAHARASHTRA |
02067216600
drhemantkumart@gmail.com |
| Dr Ajit Singh |
RUHS College of Medical Sciences and Hospital |
OPD Block, Sector-11. Kumbha Marg, Pratap Nagar, Jaipur302033
Jaipur
RAJASTHAN |
9829135692
dr.ajeetsingh@yahoo.com |
| Dr Rajvee Shah |
Sheth Vadilal Sarabhai General Hospital |
Madalpur Gam, Paldi, Road, Ellisbridge, Ahmedabad-380006
Ahmadabad
GUJARAT |
9909007196
rajveeshah86.rk@gmail.com |
| Dr Shyamal Balki |
Shree Hospital & Critical Care Centre |
799, Om Nagar,
Opp. Tajshree Building, Sakkardara Sq., Nagpur-440009
Nagpur
MAHARASHTRA |
9665477444
drshyamalb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM Medical College |
Approved |
| IEC Lata Mangeshkar Medical Foundation’s Deenanath Mangeshkar Hospital and Research Centre |
Submittted/Under Review |
| IEC Sardarmal Khandaka Memorial Hospital |
Approved |
| Institutional Ethics Committee, Assured Care Plus Hospital |
Submittted/Under Review |
| Institutional Ethics Committee for Human Research (IECHR), Medical College & S.S.G. Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Sijua |
Submittted/Under Review |
| Institutional Ethics Committee, B. J. Medical College and Civil Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, KLE University KLE Dr PK Hospital and MRC |
Submittted/Under Review |
| Institutional Ethics Committee, SV Sumandeep Vidyapeeth |
Submittted/Under Review |
| Institutional Ethics Committee- Mysore Medical College and Research Institute and Associated Hospitals |
Submittted/Under Review |
| Nirmal Hospital Ethics Committee |
Approved |
| O & P Institutional Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Submittted/Under Review |
| Shree Hospital Ethics Committee |
Submittted/Under Review |
| UHS CMS Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Treatment Phase, Arm 1 |
Barzolvolimab 150 mg every 4 weeks (Q4W) |
| Intervention |
Active Treatment Phase, Arm 2 |
Barzolvolimab 300 mg every 8 weeks (Q8W) |
| Intervention |
Active Treatment Phase, Arm 3 |
Barzolvolimab 150 mg Q4W following a loading dose of 300 mg at Week 24 (Arm 3 Dose level 1), or barzolvolimab 300 mg Q8W following a loading dose of 450 mg at Week 24 (Arm 3 Dose level 2) (1:1 re-randomization of Arm 3 Placebo Q4W) |
| Comparator Agent |
Placebo-controlled Treatment Phase, Arm 1 |
Barzolvolimab 150 mg every 4 weeks (Q4W) following a loading dose of 300 mg on Day 1 |
| Comparator Agent |
Placebo-controlled Treatment Phase, Arm 2 |
Barzolvolimab 300 mg every 8 weeks (Q8W) following a loading dose of 450 mg on Day 1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Read, understood, and provided written informed consent, and Health Insurance Portability and Accountability Act (HIPAA) authorization if applicable, after the nature of the study has been fully explained. Participants must be able to provide informed consent themselves.
2. Male or female, greater than or equal to 18 years of age at the time of signing the informed consent.
3. Diagnosis of CSU greater than or equal to 6 months prior to Screening.
4. CSU refractory to a stable dose and regimen containing a second-generation H1AH as
defined by all of the following:
Recurrent pruritic wheals with or without angioedema for greater than or equal to 6 weeks at any time prior to Screening (Visit 1) despite treatment with a H1AH (hives consistent with CSU should be documented and confirmed by the investigator prior to randomization)
Participants must have been on a stable dose and regimen containing a second generation
H1 antihistamine (H1AH) at approved or increased (up to 4x approved) dose as background therapy for the treatment of CSU for greater than or equal to 4 weeks prior to randomization and which is expected to remain stable throughout the study.
UAS7 (range: 0 to 42) greater than or equal to 16 and ISS7 (range: 0 to 21) greater than or equal to 8 during the 7-day period
(Day -7 to Day -1) immediately prior to randomization.
5. Willing and able to comply with all study requirements and procedures, including the
completion of a daily symptom diary during screening and throughout the study.
|
|
| ExclusionCriteria |
| Details |
1. Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), autoimmune syndromes with urticarial lesions (e.g., Schnitzler Syndrome) and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency).
2. Active chronic inducible urticaria (CIndU) including symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria that would confound CSU assessments based on the investigators clinical judgment.
3. Any other active pruritic skin diseases that would confound CSU assessments based on the investigator clinical judgment.
4. Planned or anticipated use of any prohibited medications during screening and study
treatment, and follow-up.
5. Prior receipt of barzolvolimab or other anti-KIT therapy.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
activity as assessed by weekly urticaria activity score (UAS7) |
Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
activity as assessed by weekly itch severity score (ISS7) and weekly hive severity score
(HSS7) |
Week 12 |
valuate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
activity in participants refractory to omalizumab treatment |
Week 12 |
| Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria activity |
Weeks 4, 24, and 52 |
Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
activity in participants refractory to omalizumab treatment |
Weeks 4, 24, and 52 |
| Evaluate the clinical effect of barzolvolimab on the health-related quality of life |
Weeks 12, 24, and 52 |
|
|
Target Sample Size
|
Total Sample Size="915"
Sample Size from India="250"
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)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="24" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 3, randomized, double-blind, placebo-controlled, parallel group study evaluating the efficacy and safety profile of 2 dose regimens of barzolvolimab in patients with CSU who remain symptomatic despite treatment with H1AH. There is a Screening Phase that lasts 2 to 4 weeks, a 24-week Placebo-controlled Treatment Phase, a 28-week Active Treatment Phase, and a 16-week Follow-up Phase. Participants randomized to placebo for the Placebo-controlled Treatment Phase will undergo a re-randomization at Week 24 to determine treatment assignment during the Active Treatment Phase. |