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    Summary
    EudraCT Number:2021-000149-42
    Sponsor's Protocol Code Number:SYN008-002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-18
    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 number2021-000149-42
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Parallel group, Active Controlled Study to Compare the Efficacy and Safety of SYN008 to Xolair® in Adult Patients with Chronic Spontaneous Urticaria and Inadequate Response to H1 Antihistamine Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines
    A.4.1Sponsor's protocol code numberSYN008-002
    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 SponsorSynermore Biologics Co., Ltd
    B.1.3.4CountryTaiwan
    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 supportSynermore Biologics Co., Ltd
    B.4.2CountryTaiwan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynermore Biologics Co., Ltd
    B.5.2Functional name of contact pointEric I Tsao
    B.5.3 Address:
    B.5.3.1Street Address6F, No 5-6, Aly 22, Ln 513, Ruiguang Rd. Neihu Disit
    B.5.3.2Town/ cityTaipei City
    B.5.3.3Post code11492
    B.5.3.4CountryTaiwan
    B.5.4Telephone number011 886 2.2659.0988
    B.5.6E-mailetsao@synermore.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 name Omalizumab
    D.3.2Product code SYN008
    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 codeSYN008 Omalizumab
    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 No
    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.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.2.5The 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
    D.3.4Pharmaceutical form Solution for infusion 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.3.9.4EV 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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic spontaneous urticaria (Allergic asthma, Chronic rhinosinusitis with nasal polyps)
    E.1.1.1Medical condition in easily understood language
    Asthma, urticaria, Chronic rhinosinusitis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10080060
    E.1.2Term Chronic rhinosinusitis with nasal polyps
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate equivalent efficacy of SYN008 and Xolair in patients with chronic spontaneous urticaria (CSU) and inadequate response to H1 antihistamine treatment
    E.2.2Secondary objectives of the trial
    • Evaluate the efficacy profile of SYN008 compared with Xolair over time based on secondary efficacy end points
    • Evaluate the safety and tolerability profile of SYN008 compared with Xolair over the entire study period
    • Evaluate the immunogenicity profile of SYN008 compared with Xolair in terms of anti-drug antibody (ADAs) production
    • Evaluate trough serum omalizumab (Ctrough) of both treatment groups over the study
    • Evaluate the pharmacodynamic (PD) effects of SYN008 compared with Xolair
    • Assess safety and immunogenicity following transition from Xolair to SYN008
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following criteria to be included in the study:
    1. Have read, understood, and signed the informed consent form (ICF) before any protocol-specific procedure including screening procedures.
    2. Male or female aged ≥ 18 years with a clinical diagnosis of CSU for at least 6 months prior to first administration of study drug.
    3. Have a diagnosis with CSU refractory to H1 antihistamines defined as:
    a. Presence of hives associated with itch for > 6 consecutive weeks at any time prior to screening despite concomitant H1 antihistamines treatment.
    b. UAS7 ≥ 16 and ISS7 ≥ 8 during the 7 days (without any missing day in the completion of the symptom e-diary) prior to first administration of study drug.
    c. Use of H1 antihistamines at a stable dose up to 4-fold the approved dose for ≥ 3 consecutive days immediately prior to Screening Visit and throughout the study (list of permitted antihistamines in APPENDIX 2).
    4. Must be willing to continue H1 antihistamines at stable dose throughout the study.
    5. Must be willing and able to complete a symptom diary twice daily for 7 days prior to first administration of study drug and throughout the study.
    6. Females of childbearing potential (FOCBP) and male patients with a female partner of childbearing potential must be willing to take reliable contraceptive precautions throughout the study (until Week 32).
    If an FOCBP, patient should have a negative pregnancy test result at Screening and Baseline visits
    Must be willing to comply with precautions to reduce the risk of COVID-19 infection in accordance with recommendations from the applicable medical associations and the investigator for the duration of the study and to undergo COVID-19 polymerase chain reaction (PCR) test as required based on the investigator judgment and/or local requirements.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
    1. Known hypersensitivity to omalizumab, study treatment excipients, or components of injecting devices.
    2. Previous exposure to omalizumab (either Xolair or a biosimilar product).
    3. Previous exposure to ligelizumab or any IgE antagonists.
    4. Having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria.
    5. Conditions that may have urticarial or angioedema symptoms (eg, urticaria pigmentosa, urticarial vasculitis, hereditary or acquired angioedema, erythema multiforme, mastocytosis, lymphoma).
    6. Has the evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. Stool testing will be conducted only in patients presenting at screening with a risk factor for parasitic infection (living in endemic region, chronic gastrointestinal symptoms, and/or chronic immunosuppression) and an eosinophil count > 2 × upper limit of normal (ULN).
    7. Positive serology results of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody) at screening.
    8. Any other skin disease associated with chronic itching that might influence in the investigator’s opinion the study evaluations and results (eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus).
    9. Any current active infection requiring treatment.
    10. Body temperature of 37.5 °C or above at screening or baseline visits, and/or signs or symptoms that in the opinion of the investigator may be suggestive of COVID-19 infection. The patient may be allowed to enter the study if a COVID-19 PCR test performed during the Screening Period results in a negative outcome or had received an approved COVID-19 vaccine (if available), based on investigator’s clinical judgment.
    11. Has received H2 antihistamines and/ or LTRAs within 7 days prior to Screening Visit.
    12. Routine doses (ie, daily or every other day for ≥ 5 consecutive days) of systemic or cutaneous (topical) corticosteroids (prescription or over-the-counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide within 30 days prior to Screening Visit. 13. Intravenous immunoglobulin G (IVIG), or plasmapheresis within 30 days prior to Screening Visit.
    14. Regular (daily/every other day) use of oral doxepin ≤ 2 weeks prior to Screening Visit.
    15. Treatment with an investigational agent ≤ 30 days or ≤ 5 × half-life, whichever is longer, prior to Screening Visit.
    16. Has a current or history of malignancy, except non-melanoma skin cancer that has been treated or excised and is considered resolved.
    17. History of anaphylactic reaction.
    18. Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, or other pathological conditions including abnormal blood/urine test results that could, in the investigator’s opinion, interfere with the interpretation of the study results and or compromise the safety of the patients.
    19. History of and/or concomitant immune complex disease (including Type III hypersensitivity), hyperimmunoglobulin E syndrome, autoimmune disease or bronchopulmonary aspergillosis.
    20. Evidence of current or history within the past year of drug or alcohol abuse based on investigator’s judgment.
    21. Pregnant or nursing (lactating) women.
    22. Is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 12 in weekly itch-severity score (ISS7)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline to Week 12
    E.5.2Secondary end point(s)
    Efficacy:
    • Change of ISS7 from Baseline to Week 4
    • Change of ISS7 from Baseline to each study visit other than Week 4 or Week 12
    • Changes of weekly hive severity score (HSS7) from Baseline to each study visit
    • Change of weekly urticaria activity score (UAS7) from Baseline to each study visit
    o Proportion of patients with UAS7 ≤ 6 at Week 12 and Week 32 visits
    o Proportion of patients with UAS7 = 0 at Week 12 and Week 32 visits
    o Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 12, Week 20, and Week 32.

    Safety:

    • Adverse events (AEs), including treatment-emergent adverse events (TEAEs), Serious AEs (SAEs), treatment-related AEs, treatment-related SAEs, and adverse events of special interest (AESIs)
    • Injection site reactions
    • Laboratory parameters, hematology, chemistry, and urinalysis
    • Vital signs
    • Physical examination
    • 12-lead Electrocardiogram (ECG)

    Imunogenicity:
    • Proportion of patients developing ADA and Neutralizing Antibody (NAb) to omalizumab over the course of the study.
    Pharmacokinetics
    • Trough serum concentration (Ctrough) of omalizumab at predose over the course of the study for both treatment groups
    Pharmacodynamics
    • Change in serum concentration of total and free anti-immunoglobulin E (IgE) from baseline over the course of the study for both treatment groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Change of ISS7 from Baseline to Week 4
    - Change of ISS7 from Baseline to each study visit other than Week 4 or Week 12
    - Change of weekly hive severity score (HSS7) from Baseline to each study visit
    - Change of urticarial activity score (UAS7) from Baseline to each study visit
    - Proportion of patients with UAS7 ≤ 6 and UAS7 = 0 Week 12 and Week 32 visits
    - Change in Dermatology of Life Quality Index (DLQI) from Baseline to Week 12, Week 20, and Week 32.
    - AEs, SAEs, AESIs and Injection site reactions trough all study
    -Imunogenicity, Pharmacokinetics and Pharmacodynamics from baseline over the course of the study
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 SYN008 to Xolair in adult patients with CSU
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Russian Federation
    Bulgaria
    Hungary
    Poland
    Romania
    Slovakia
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 480
    F.1.3Elderly (>=65 years) No
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 336
    F.4.2.2In the whole clinical trial 480
    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)
    No further treatment from the expected normal treatment of that condition
    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 Decision2021-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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