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    Summary
    EudraCT Number:2020-004504-33
    Sponsor's Protocol Code Number:BAT-2206-002-CR
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-09
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-004504-33
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients with Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients
    with Moderate to Severe Plaque Psoriasis
    A.4.1Sponsor's protocol code numberBAT-2206-002-CR
    A.5.4Other Identifiers
    Name:China INDNumber:CXSL1900103
    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 SponsorBio-Thera Solutions, Ltd.
    B.1.3.4CountryChina
    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 supportBio-Thera Solutions, Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBio-Thera Solutions, Ltd.
    B.5.2Functional name of contact pointXiaoGe Jia
    B.5.3 Address:
    B.5.3.1Street AddressFloor 5, Building A6, Science Enterprise Accelerator, 11 Kaiyuan Avenue, Science City
    B.5.3.2Town/ cityHuangpu District, Guangzhou, Guangdong Province
    B.5.3.3Post code510530
    B.5.3.4CountryChina
    B.5.4Telephone number+8617665187738
    B.5.6E-mailxgjia@bio-thera.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 nameRecombinant Human Anti-IL12 Monoclonal Antibody
    D.3.2Product code BAT2206
    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 INNRecombinant Human Anti-IL12 Monoclonal Antibody
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeBAT2206
    D.3.9.3Other descriptive nameUstekinumab
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45/0.5
    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.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 Stelara®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical 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.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUstekinumab
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45/0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    chronic autoimmune disorder that causes the excessive buildup of skin cells
    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 SOC
    E.1.2Classification code 10040785
    E.1.2Term Skin and subcutaneous tissue disorders
    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
    The primary objective of the study is to demonstrate equivalent efficacy of BAT2206 and Stelara in patients with moderate to severe psoriasis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • To evaluate the efficacy of BAT2206 compared with Stelara over time based on secondary efficacy endpoints.
    • To evaluate the safety and tolerability of BAT2206 compared with Stelara over the entire study period.
    • To evaluate the immunogenicity of BAT2206 compared with Stelara.
    • To evaluate the steady-state PK of BAT2206 compared with Stelara.
    • To assess safety and immunogenicity after transition from Stelara to BAT2206.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥ 18 years with a diagnosis of plaque-type psoriasis at least 24 weeks before screening.
    2. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
    a. PASI ≥ 12,
    b. sPGA ≥ 3, and
    c. BSA affected by chronic plaque-type psoriasis ≥ 10%
    3. Failed to respond to, have a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate, or PUVA
    4. Female patients of childbearing potential and male patients with a female partner of childbearing potential must be willing to use highly effective contraceptive precautions throughout the study period and continuing for at least 15 weeks after the last dose of study drug. Abstinence from heterosexual intercourse is accepted when this is the usual lifestyle of the patient and must be continued for at least 15 weeks after the last dose of study drug. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or surgically sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
    5. If female of childbearing potential, patient should have a negative pregnancy test result at screening and baseline visits.
    6. Must be willing to provide written consent and to comply with the requirements of the study protocol.
    E.4Principal exclusion criteria
    1.Have any forms of psoriasis at the time of the screening visit other than plaque-type, such as erythrodermic psoriasis,pustular psoriasis, guttate psoriasis,medication-induced psoriasis,or other skin conditions(eg, eczema)that would interfere with evaluations of the effect of investigational product on psoriasis
    2.Have previously received ustekinumab,a biosimilar of ustekinumab,or any drug that targets interleukin-12, interleukin-17 or interleukin-23
    3.Weight >120 kg
    4.Have received any monoclonal antibody-based biologic drugs for the treatment of Psoriasis(PsO)or Psoriatic arthritis(PsA)other than those prohibited (see exclusion #2)within 5 half-lives of the drugs before the screening visit
    5.Have received non-monoclonal antibody biological drugs(eg, etanercept)for the treatment of PsO or PsA within 12 weeks or 5 half-lives (whichever is longer)before the screening visit
    6.Have received topical therapies for the treatment of psoriasis(such as corticosteroids,vitamin D analogs,or retinoids)within 2 weeks before baseline visit. 7.Have received ultraviolet (UV) A phototherapy(with or without oral psoralen),UVB phototherapy,any systemic steroids,or nonbiological drugs(such as methotrexate, apremilast,sulfasalazine, azathioprine,JAK inhibitors,or other immunosuppressive agents)for the treatment of PsO or PsA within 4 weeks before baseline visit
    8.Have received any investigational drug within 8 weeks or 5 half-lives (whichever is longer)before the screening visit(in case of monoclonal antibody-based investigational drugs exclusion #4 applies)
    9.Have received any herbal remedies or traditional medicines used to treat psoriasis or PsA within 4 weeks before baseline visit
    10.Have current or chronic inflammatory or autoimmune disease other than plaque psoriasis that may confound the evaluation of the effect of
    the study treatment.Patients with concurrent PsA will be allowed to participate
    11.History of allergy to the active substance or any of the excipients of study drugs,or of hypersensitivity to latex
    12.Have received a live vaccination within 4 weeks before the baseline visit(1 year before initiating treatment for Bacillus Calmette–Guerin vaccines). (Patient must agree not to receive a live vaccination during the study and up to 15 weeks [1 year for Bacillus Calmette–Guerin vaccines] after the last dose of the study drug).COVID-19 vaccination will not be allowed for 4 weeks before randomization or for 2 weeks before each dosing (Week 4,Week 16, Week 28,and Week 40)during the study
    13.Have clinical signs or symptoms consistent with coronavirus disease 2019 (COVID-19)infection within the last 4 weeks before screening or during screening. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required.
    14.History of invasive infection
    15.Presence of active infection at screening, history of infection requiring intravenous antibiotics and/or hospitalization ≤ 8 weeks before baseline visit,or oral antibiotics ≤2 weeks before baseline visit.Minor fungal infections may be allowed
    16.Any recurrent bacterial, fungal,or viral infection that makes the patient unsuitable for the study,including recurrent/disseminated herpes zoster
    17.Meet criteria relative to latent or active tuberculosis infection as described in the protocol
    18.Presence of any of the abnormal laboratory test results at screening as described in the protocol
    19.Positive HIV(HIV-1 and HIV-2),hepatitis B,or hepatitis C serological result
    20.Evidence of malignancy, lung infection,or abnormalities suggestive of active TB on chest radiography performed within 12 weeks before the screening visit or during the screening period 21.Significant medical problems as described in the protocol
    22.Any history of malignancy or lymphoproliferative disease at any time,except curative treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix 23.Have a transplanted organ/tissue or stem cell transplantation
    24.Have an underlying metabolic,hematologic,renal, hepatic,pulmonary, neurologic,endocrine,cardiac, infectious,or gastrointestinal condition,which in the opinion of the investigator places the patient at unacceptable risk
    25.Have a history of demyelinating diseases (including myelitis)or neurologic symptoms suggestive of demyelinating disease
    26.Any major surgical procedure within 12 weeks of the baseline visit or planned during the study
    27.Patient is not willing to limit UV light exposure during the study
    28.History of clinically significant drug or alcohol abuse within the last 12 months as judged by the investigator
    29.Pregnant or breastfeeding (lactating)women
    30.Patient is considered by the investigator,for any reason,to be an unsuitable candidate for the study
    31.Patients participating in another investigational drug or device trial or planning on participating in another clinical trial during the course of the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is percent change from baseline (CfB) in Psoriasis Area and Severity Index (PASI) score to Week 8 (EMA) or
    Week 12 (all other agencies).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two timepoints (Week 8 or Week 12) will be analyzed independently as primary for this measure, depending on the regulatory agency for
    submission.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are as follows:
    • Percent CfB in PASI score to Weeks 4, 16, 20, 28, 32, 40, 44 and 52
    • Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI-50/75/90/100) at Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52
    • Area under the effect curve (AUEC) for PASI from baseline to Weeks 8, 12, and 28.
    • CfB in static Physician’s Global Assessment (sPGA) score to Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52
    • Proportion of patients with sPGA score on a 6-item scale of cleared (0) or minimal (1) at Week 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52
    • CfB in affected body surface area (BSA) at Weeks 4, 8, 12, 16, 20, 28, 32, 40, 44 and 52
    • CfB in Dermatology Life Quality Index (DLQI) score to Weeks 8, 12, 28, 40, and 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints already included in end points
    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 No
    E.6.8Bioequivalence No
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    China
    Georgia
    Russian Federation
    Bulgaria
    Poland
    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
    The end of the study or study completion will be the last patient’s last visit for any protocol-related activity
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 445
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 111
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 253
    F.4.2.2In the whole clinical trial 556
    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 Decision2021-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-07
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