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    Summary
    EudraCT Number:2022-001745-20
    Sponsor's Protocol Code Number:BP11-301
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2022-001745-20
    A.3Full title of the trial
    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
    III. fázisú, randomizált, kettős vak, párhuzamos csoportos, multicentrikus vizsgálat a BP11 hatásosságának, biztonságosságának, farmakodinámiájának, farmakokinetikájának és immunogenitásának az EU által jóváhagyott Xolair® készítménnyel szembeni összehasonlítására krónikus spontán csalánkiütésben szenvedő, H1 antagonistával szemben rezisztens betegeknél.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, Safety, PD, PK, and Immunogenicity of BP11 Compared With Xolair
    A.4.1Sponsor's protocol code numberBP11-301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCuraTeQ Biologics Private Ltd.
    B.1.3.4CountryIndia
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCuraTeQ Biologics Private Ltd.
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCuraTeQ Biologics Private Ltd.
    B.5.2Functional name of contact pointAssistant general manager
    B.5.3 Address:
    B.5.3.1Street AddressGalaxy, Floors: 22-24, Plot No. 1, Survey No. 83/1, Hyderabad Knowledge City, Raidurg Panmaktha
    B.5.3.2Town/ cityRangareddy Dist., Hyderabad, Telangana
    B.5.3.3Post code500081
    B.5.3.4CountryIndia
    B.5.4Telephone number+918455 255222
    B.5.6E-mailArpitkumar.Prajapati@curateqbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOmalizumab solution for injection in prefilled syringe
    D.3.2Product code BP11
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmalizumab
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeBP11
    D.3.9.3Other descriptive namerhuMAb-E25, anti-IgE monoclonal antibody E25
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeProposed biosimilar to Xolair® (omalizumab)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xolair 150 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameXolair 150 mg solution for injection in pre-filled syringe
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmalizumab
    D.3.9.1CAS number 242138-07-4
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameAnti-IgE monoclonal antibody E25
    D.3.9.4EV Substance CodeSUB12543MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Spontaneous Urticaria
    E.1.1.1Medical condition in easily understood language
    Chronic Urticaria
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072757
    E.1.2Term Chronic spontaneous urticaria
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate therapeutic equivalence between BP11 and Xolair in patients with chronic spontaneous urticaria (CSU) with an inadequate response to H1 antihistamine (H1AH) treatment
    E.2.2Secondary objectives of the trial
    - To assess and compare other efficacy parameters between BP11 and Xolair over time;

    - To assess and compare safety and tolerability between BP11 and Xolair over the entire study period;

    - To assess and compare immunogenicity between BP11 and Xolair over the study;

    - To assess and compare the PK between BP11 and Xolair over the study;

    - To assess and compare the PD between BP11 and Xolair.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients 18 to 75 years of age (inclusive) willing and able to provide informed consent

    - A diagnosis of CSU for at least 6 months before randomization

    - A diagnosis of CSU refractory to H1AH treatment as defined in the protocol

    - A diagnosis of CSU refractory to H1AH treatment as defined in the protocol

    - Able to provide patient e-diary entries (without missing data) for the last 7 consecutive days before randomization

    - Willing and able to complete an e-diary twice daily (morning and evening) up to 24 weeks

    - Females of childbearing potential (FOCBP) and males with a female partner of childbearing potential must be willing to use reliable contraceptive precautions throughout the study until 6 months after the last study treatment dose.

    - If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits
    E.4Principal exclusion criteria
    - Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients

    - Previous exposure to omalizumab (Xolair or biosimilar omalizumab)

    - Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias

    - 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

    - History of and/or current disease as defined in the protocol

    - History of and/or current disease as defined in the protocol

    - Proof of a COVID-19 vaccination within the 2 weeks before randomization

    - History of and/or an ongoing use of medications as defined in the protocol

    - History of and/or an ongoing use of medications as defined in the protocol

    - Any contraindication to use of diphenhydramine

    - Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites

    - Current or history of drug or alcohol abuse within the past year based on the investigator’s judgment

    - 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

    - 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

    - 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

    - Inability to comply with the study and follow-up procedures
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Change from Baseline in ISS7 at Weeks 2, 4, 8, 16, 20, and 24

    Change from Baseline in weekly Urticaria Activity Score (UAS7) at
    Weeks 2, 4, 8, 12, 16, 20, and 24

    Percentage of patients with UAS7 of ≤6 at Weeks 2, 4, 8, 12, 16, 20, and 24

    Percentage of complete responders (UAS7 = 0) in UAS7 at Weeks 2, 4, 8, 12, 16, 20, and 24

    Change from Baseline in weekly Hives Severity Score (HSS7) at Weeks 2, 4, 8, 12, 16, 20, and 24

    Change from Baseline in the overall Dermatology Life Quality Index (DLQI) score at Weeks 4, 8, 12, 16, 20, and 24

    Use of rescue medication up to scheduled efficacy time points and over the study (at Weeks 2, 4, 8, and 12, and by treatment period)

    Incidence, nature, and severity of adverse events (AEs) including adverse drug reactions graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 as defined by treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), related TEAEs, and related SAEs during Treatment Period 1 (TP1) and Treatment Period 2 (TP2)

    Injection-site and hypersensitivity reactions at Baseline (Week 0 after first study drug dose) and at Weeks 4, 8, 12, 16, and 20, and throughout the study

    Physical examinations, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study

    Laboratory parameters (hematology, serum chemistry, and urinalysis)
    throughout the study

    Incidence of antidrug antibodies (ADAs) and neutralizing antibodies
    (NAbs) and ADA titers to omalizumab measured during TP1 at Baseline
    (Week 0) and at Weeks 4 and 12

    Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 at Weeks 20, 24, and 40

    Trough serum concentration (Ctrough) of omalizumab during TP1 at Baseline and at Weeks 4 and 12

    Trough serum concentration (Ctrough) of omalizumab during TP2 at Weeks 20, 24, and 40

    Total IgE and free IgE levels in serum during TP1 at Baseline (Week 0) and at Weeks 4 and 12

    Total IgE and free IgE levels in serum during TP2 at Weeks 20, 24, and 40

    Incidence, nature, and severity of AEs including adverse drug reactions graded according to the NCI CTCAE v5.0 as defined by TEAEs, SAEs, AESIs, related TEAEs, and related SAEs during TP2 for patients who switch treatment

    Injection-site and hypersensitivity reactions during TP2 for patients who switch treatment

    Physical examinations, vital signs, and 12-lead ECGs during TP2 for patients who switch treatment

    Laboratory parameters (hematology, clinical chemistry, and urinalysis)
    during TP2 for patients who switch treatment

    Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 for patients who switch treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Latvia
    Lithuania
    Poland
    Bulgaria
    Czechia
    Georgia
    Hungary
    Slovakia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-07
    P. End of Trial
    P.End of Trial StatusOngoing
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