CTRI/2024/07/070105 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On:
10/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Efficacy and Safety study of BP11 (Omalizumab) with Xolair® in Patients with Chronic Spontaneous Urticaria
Scientific Title of Study
A Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Patients with Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
2022-001745-20
EudraCT
BP11-301, Version No. 2.0 dated 17-Jan-2024
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
Dr Arpitkumar Prajapati
Designation
General Manager
Affiliation
CuraTeQ Biologics Private Ltd.
Address
CuraTeQ Biologics Private Ltd. Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India -500081
Hyderabad TELANGANA 500081 India
Phone
8455255222
Fax
Email
arpitkumar.Prajapati@curateqbio.com
Details of Contact Person Public Query
Name
Dr Arpitkumar Prajapati
Designation
General Manager
Affiliation
CuraTeQ Biologics Private Ltd.
Address
CuraTeQ Biologics Private Ltd. Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India -500081
K.L.E.S. Dr. Prabhakar Kore Hospital and Medical Research Centre
Department of Dermatology, OPD No- 23, Nehru Nagar Belagavi Karnataka -590010 India Belgaum KARNATAKA
9844512315
shivakumarpatil@gmail.com
Dr Chandra Sekhar Sirka
All India Institute of Medical Sciences (AIIMS)
Department of Dermatology, Room No 137, Sijua, Patrapada, Dumduma, Bhubaneswar – 751019, Odisha, India Khordha ORISSA
9438884055
csirka2006@gmail.com
Dr Kiran Godse
Dr. D.Y Patil Medical College Hospital and Research Centre, OPD
Department of Dermatology, OPD No- 60, 61 and 62, Sec-5, Nerul, Navi-Mumbai 400706 Mumbai MAHARASHTRA
9322266687
drgodse@gmail.com
Dr Ramesh Bhat
Father Muller Charitable Institutions (FMCI)
Department of Dermatology, OPD No- 65,Fr Muller Road, Kankanady, Mangalore-575 002, Karnataka, India
Bangalore KARNATAKA
9845084224
rameshderma@gmail.com
Dr Praneeth Kumar Gunda
Gleneagles Global Hospitals, Hyderabad
Department of Dermatology, OPD No- 12,
6-1-1070/1 to 4, Lakdi-ka-put, Hyderabad, Telangana Hyderabad TELANGANA
8897738888
drpraneethg@gmail. com
Dr Krina Bharat Patel
GMERS Medical College & Civil Hospital Sola
Department of Dermatology ,2nd Floor, Block A, Nr. Gujarat High court, S.G. Highway, Sola, Ahmedabad-380060, Gujarat, India Ahmadabad GUJARAT
9227222221 91-79-27661187 drkbpateI66@gmail.cam
Dr Davinder Parsad
Institutional Ethics Committee. Post Graduate institute of Medical Education and Research
Department of Dermatology, Venereology and Leprology, Room No 5009, 2nd floor, D Block, Sector 12, Chandigarh-160012, India 160012
India
Chandigarh CHANDIGARH
9438884055
csirka2006@gmail.com
Dr Dev Prakash Shivhare
LLR Hospital, GSVM medical college
Department of Dermatology, Swaroop Nagar, Kanpur-208002, India Kanpur Nagar UTTAR PRADESH
9450136374
Drdev.derma@gmail.com
Dr Sumathy TK
M S Ramaiah Medical College and Hospital, Bangalore
Department of Dermatology, Department no 104, OPD No- 105
M S Ramaiah Nagar, MSRIT Post,
Bengaluru-560054
Bangalore KARNATAKA
9845163009
tksumathy@gmail.com
Dr Bangaru H
Mysore Medical College (MMC) and Research Institute (RI) - Krishna Rajendra Hospital (KR Hospital)
Dermatology, Room No 14,
Attached to Mysore Medical College and Research Institute, Irwin Road -570001,Mysuru,Karnataka, India
Mysore KARNATAKA
9886789231
drbangaruskin@gmail.com
Dr Perumal Manoharan
Panimalar Medical College Hospital and Research Institute
Department of Dermatology, Room No-215, Varadharajapuram,
Poonamallee, Chennai - 600123, India.
Thiruvallur TAMIL NADU
9629048549
ethosinpmchri@gmail.com
Dr Hari Kishan Y Kumar
Raja Rajeswari Medical College and Hospital
Department of Dermatology, Room No. 1121,
No.202, Kambipura, Mysore Road, Bangalore,
Karnataka - 560074, India
Bangalore KARNATAKA
9902066568
drharikishankumar@gmail.com
Dr Ruchir Hitendrabhai Shah
Sanjivani Super Speciality Hospital Pvt.Ltd
Research Department, 1, Uday park Society, Nr. Sunrise Park, Vastrapur,
Ahmedabad-380015, Gujarat, India
Ahmadabad GUJARAT
0792630 6341 07926307165 sanjivanissh@yahoo.com
Dr Rashmi Singh
Shubham Sudbhavawana Superspeciality Hospital
Clinical Research Department, Room No- 303, Sijua, Patrapada, Dumduma, Bhubaneswar – 751019, Odisha, India Varanasi UTTAR PRADESH
INSTITUTIONAL ETHICS COMMITTEE GMERS Medical College and Civil Hospital
Approved
Institutional Ethics Committee, D Y Patil Medical College
Approved
Institutional Ethics Committee, KLE University
Approved
Institutional Ethics Committee, Raja Rajeswari Medical College and Hospital
Approved
Institutional Ethics Committee-Mysore Medical College and Research Institute and Associated Hospital, KR Hospital attached To Mysore Medical College and Research Institute,
Approved
Institutional Ethics Committee. Post Graduate institute of Medical Education and Research
Approved
Institutional Human Ethics Committee, Panimalar Medical College Hospital & Research Institute
Approved
Sanjivani Hospital Ethics Committee
Approved
Shubham Sudbhawana Super. Hosp. Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L501||Idiopathic urticaria,
Intervention / Comparator Agent
Type
Name
Details
Intervention
BP11
150 mg (150 mg/mL) SC injections or
300 mg (150 mg/mL) SC injections
Duration: Week 0,4, 8, 12,16 and 20
Comparator Agent
Xolair®
150 mg (150 mg/mL) SC injections or
300 mg (150 mg/mL) SC injections
Duration: Week 0,4, 8, 12,16 and 20
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Male or female patients 18 to 60 years of age (inclusive) willing and able to provide informed consent.
2. A diagnosis of CSU for at least 6 months before randomization.
3. Patient must be willing to complete e-diary twice daily (morning and evening). Able to provide e-diary entries for at least 4 consecutive days out of 7 days before randomization.
4. Willing and able to complete an e-diary twice daily (morning and evening) up to 24 weeks
5. Females of childbearing potential (FOCBP) and males with a female partner of childbearing potential must be willing to use reliable contraceptive precautions (refer to Appendix 1 for details) throughout the study until 6 months after the last study treatment dose.
6. If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits
ExclusionCriteria
Details
1. Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients.
2. Previous exposure to omalizumab (Xolair or biosimilar omalizumab).
3. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias.
4. Any of the following diseases, which may have symptoms of urticaria and/or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer.
5. Proof of a COVID-19 vaccination within the 2 weeks before randomization.
6. Current or history of drug or alcohol abuse within the past year based on the investigator’s judgment.
7. Contraindication to background therapy and/or rescue therapy with H1AHs or contraindication to epinephrine or other components of these agents as per the investigator’s discretion.
8. To ensure complete systemic elimination of the study drug, any female who is currently pregnant or breastfeeding or plans to become pregnant or breastfeed for 6 months after the last dose of assigned study treatment or any male who is planning to father a child or donate sperm during the study period or for 6 months after the last dose of assigned study treatment.
9. Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients in the opinion of the investigator.
10. Inability to comply with the study and follow-up procedures
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change from Baseline in weekly Itch Severity Score (ISS7) and
Relative potency based on change from Baseline in ISS7
Week 12
Secondary Outcome
Outcome
TimePoints
Efficacy
Various time points from baseline to week 24
safety and tolerability
Throughout study duration
Immunogenicity
Various time points from baseline (week 0) to week 40
Pharmacokinetics
Various time points from baseline (week 0) to week 40
Pharmacodynamics
Various time points from baseline (week 0) to week 40
Target Sample Size
Total Sample Size="600" Sample Size from India="200" 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)
01/08/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
05/10/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
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
Chronic spontaneous urticaria (CSU) is defined as a severe and distressing skin condition characterized by red, swollen, itchy, and sometimes painful wheals (hives) on the skin with an unknown or autoimmune trigger that are present on most days of the week for at least 6 weeks.
Omalizumab (Xolair®) is a recombinant humanized anti-immunoglobulin E (IgE) monoclonal antibody. Xolair binds to free IgE and reduces the levels of free IgE and its high-affinity receptor FcεRI, both of which are essential in mast cell and basophil activation. It has not yet been fully elucidated how this results in CSU improvement. However, as per Kaplan et al,7 potential mechanisms in CIU/CSU include reducing mast cell releasability, reversing basopenia and improving basophil IgE receptor function, reducing activity of IgG autoantibodies against FcεRI and IgE, reducing activity of IgE autoantibodies against an antigen or autoantigen that has yet to be definitively identified, reducing the activity of intrinsically “abnormal†IgE, and decreasing in vitro coagulation abnormalities associated with disease activity.
This is a phase 3, randomized, double-blind, parallel-group, multicentre study to compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Patients with Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist.