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    Summary
    EudraCT Number:2020-001724-34
    Sponsor's Protocol Code Number:PS0020
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-03-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2020-001724-34
    A.3Full title of the trial
    A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the pharmacokinetics, safety, and efficacy of two doses of bimekizumab in adolescent study participants with moderate to severe plaque psoriasis
    A.3.2Name or abbreviated title of the trial where available
    BE CONNECTED
    A.4.1Sponsor's protocol code numberPS0020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04718896
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/168/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameBimekizumab Dose A
    D.3.2Product code UCB4940
    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 INNBIMEKIZUMAB
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.3Other descriptive nameBKZ
    D.3.9.4EV Substance CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 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 nameBimekizumab Dose B
    D.3.2Product code UCB4940
    D.3.4Pharmaceutical form Solution for injection
    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 INNBIMEKIZUMAB
    D.3.9.1CAS number 1418205-77-2
    D.3.9.2Current sponsor codeUCB4940
    D.3.9.3Other descriptive nameBKZ
    D.3.9.4EV Substance CodeSUB182636
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    Moderate to Severe Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Plaque Psoriasis is a
    chronic inflammatory disease characterized by
    changes in the skin.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO)
    E.2.2Secondary objectives of the trial
    -Evaluate the safety of bimekizumab in adolescents with moderate to severe plaque PSO
    -Evaluate the efficacy of bimekizumab in adolescents with moderate to severe plaque PSO
    -Evaluate the immunogenicity of bimekizumab in adolescents with moderate to severe plaque PSO
    -Evaluate the change in quality of life in adolescents with moderate to severe plaque PSO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant must be ≥12 to <18 years of age at the time of signing the informed consent/assent according to local regulation
    -Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and:
    a) Body surface area (BSA) affected by PSO ≥10%
    b) Investigator’s Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
    c) Psoriasis Area and Severity Index (PASI) score ≥12 OR
    d) PASI score ≥10 plus at least 1 of the following:
    i. Clinically relevant facial involvement
    ii. Clinically relevant genital involvement
    iii. Clinically relevant hand and foot involvement
    -Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy
    -Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline
    -Male or female
    A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance
    -Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)
    E.4Principal exclusion criteria
    -Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
    -Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
    - History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
    -Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
    -Participant has laboratory abnormalities at Screening
    -Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier
    -Presence of active suicidal ideation, or positive suicide behavior
    -Participant has been diagnosed with severe depression in the past 6 months
    E.5 End points
    E.5.1Primary end point(s)
    1. Plasma concentration of bimekizumab at Week 0
    2. Plasma concentration of bimekizumab at Week 1
    3. Plasma concentration of bimekizumab at Week 4
    4. Plasma concentration of bimekizumab at Week 8
    5. Plasma concentration of bimekizumab at Week 12
    6. Plasma concentration of bimekizumab at Week 16
    7. Plasma concentration of bimekizumab at Week 20
    8. Plasma concentration of bimekizumab at Week 36
    9. Plasma concentration of bimekizumab at Week 40
    10. Plasma concentration of bimekizumab at Week 64
    11. Plasma concentration of bimekizumab at Week 88
    12. Plasma concentration of bimekizumab at Week 112
    13. Plasma concentration of bimekizumab at Week 124
    14. Plasma concentration of bimekizumab at safety follow up (SFU)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline (Week 0)
    2. Week 1
    3. Week 4
    4. Week 8
    5. Week 12
    6. Week 16
    7. Week 20
    8. Week 36
    9. Week 40
    10. Week 64
    11. Week 88
    12. Week 112
    13. Week 124
    14. Week 140 (SFU)
    E.5.2Secondary end point(s)
    1. Percentage of participants with treatment-emergent adverse events (TEAEs)
    2. Percentage of participants with serious TEAEs
    3. Percentage of participants with TEAEs leading to discontinuation of investigational medicinal product (IMP)
    4. Percentage of participants with selected safety topics of interest
    5. Change from Baseline in vital signs (systolic and diastolic blood pressure)
    6. Change from Baseline in vital signs (heart rate or pulse rate)
    7. Change from Baseline in vital signs (temperature)
    8. Change from Baseline in physical examination findings reported as TEAEs with onset occurring from day of first dose through 20 weeks after final dose of IMP
    9. Change from Baseline in hematology parameters (platelet count)
    10. Change from Baseline in hematology parameters (mean corpuscular hemoglobin)
    11. Change from Baseline in hematology parameters (mean corpuscular volume)
    12. Change from Baseline in hematology parameters (erythrocytes)
    13. Change from Baseline in hematology parameters (hemoglobin)
    14. Change from Baseline in hematology parameters (hematocrit)
    15. Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
    16. Change from Baseline in clinical chemistry parameters (calcium, potassium, sodium, blood urea nitrogen, glucose (nonfasting))
    17. Change from Baseline in clinical chemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase)
    18. Change from Baseline in clinical chemistry parameters (creatinine, total and direct bilirubin)
    19. Change from Baseline in clinical chemistry parameters (total protein)
    20. Change from Baseline in height
    21. Change from Baseline in weight
    22. Percentage of participants with Psoriasis Area and Severity Index (PASI) 90 response at Week 16
    23. Percentage of participants with Investigator's Global Assessment (IGA) 0/1 (Clear [0]/Almost Clear [1] with at least 2-category improvement from Baseline) response at Week 16
    24. Percentage of participants with Psoriasis Area and Severity Index (PASI) 75 response at Week 4
    25. Percentage of participants with anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration
    26. Percentage of participants with anti-bimekizumab antibody (AbAb) detection following investigational medicinal product (IMP) administration
    27. Change from Baseline in Children’s Dermatology Life Quality Index (CDLQI) response at Week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. - 21. From day of first dose (Week 0) through 20 weeks after final dose of IMP (up to Week 140)
    22.; 23. Week 16
    24. Week 4
    25. Baseline (Week 0)
    26. From Week 1 through 20 weeks after final dose of IMP (up to Week 140)
    27. Week 16, compared to Baseline
    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; Tolerability
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    United States
    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.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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