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    Summary
    EudraCT Number:2017-001615-36
    Sponsor's Protocol Code Number:ABY-035-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-07
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001615-36
    A.3Full title of the trial
    A phase II, randomized, parallel group, placebo-controlled, double-blinded, dose-finding study to evaluate efficacy, safety, tolerability, and pharmacokinetics of ABY-035 in subjects with moderate-to-severe plaque psoriasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind study in subjects with moderate to severe plaque psoriasis to evaluate efficacy, safety, tolerability of four different dose levels of ABY-035 compared to placebo.
    A.3.2Name or abbreviated title of the trial where available
    AFFIRM-35 Study
    A.4.1Sponsor's protocol code numberABY-035-002
    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 SponsorAffibody AB
    B.1.3.4CountrySweden
    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 supportAffibody AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAffibody AB
    B.5.2Functional name of contact pointDirector Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressScheeles väg 2
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 76-349 58 49
    B.5.5Fax number+46 8 59 88 38 01
    B.5.6E-mailcamilla.sandell@affibody.se
    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.3.2Product code ABY-035
    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 INNizokibep
    D.3.9.1CAS number 2226130-02-3
    D.3.9.2Current sponsor codeABY-035
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 No
    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
    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
    moderate-to-severe plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    moderate-to-severe plaque psoriasis
    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 10037153
    E.1.2Term Psoriasis
    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 evaluate the efficacy, defined as Psoriasis Area and Severity Index (PASI) 90 response, of different dose levels of ABY-035 compared to placebo in subjects with moderate-to-severe plaque psoriasis after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    1. Evaluate safety, tolerability of ABY-035
    2. Evaluate efficacy of ABY-035 vs placebo after 12w treatment
    3. Evaluate efficacy, defined as PASI 90 response, of different dosing regimens of ABY-035 in subjects with moderate-to-severe plaque psoriasis after 24, 52, 76, 104, 128, 156, 180, 208, 232,
    260 w of treatment
    4. Evaluate efficacy, defined as PASI 50, 75 and 100 responses, absolute PASI scores, sPGA scores, target NAPSI scores of different ABY-035 dosing regimens in subjects with moderate-to-severe plaque psoriasis after 12, 24, 52, 76, 104, 128 156, 180, 208, 232 and 260 w of treatment (NAPSI scores not evaluated at W 76, 128, 180, 232)
    5. Evaluate change in PROs, using the DLQI, the pain-VAS and the itch-VAS following 12, 24, 52, 76, 104, 128, 156, 180, 208, 232 and 260 w of treatment with different ABY-035 dosing regimens in subjects with moderate-to-severe plaque psoriasis
    6. Evaluate PK of ABY-035 after multiple subcutaneous dosing
    7. Assess immunogenicity of ABY-035
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willingness and capability of providing written Informed Consent
    2. Male or female, aged 18-75 years (inclusive), and of any origin
    3.Diagnosed with plaque psoriasis of at least 6 months prior to Screening, suitable for systemic treatment or phototherapy, and has stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before randomization). Subjects with low active Psoriatic Arthritis may be included if they had not received systemic treatment within the last 12 months
    4. Having precedent failure, intolerance and/or contraindication to at least two standard therapies for moderate-to-severe plaque psoriasis
    (systemic therapy and/or phototherapy) and previous insufficient disease control of topical therapy (e.g. corticosteroids, vitamin D derivatives, cignolin/dithranol)
    5. Moderate-to-severe plaque psoriasis at Screening and at Baseline as defined by:
    i. Psoriasis involving ≥10% BSA
    ii. PASI score of ≥ 12
    iii. sPGA score of ≥ 3
    6. Willingness and capability of using adequate contraceptive measures from Screening visit until the Pregnancy follow-up Visit:
    i. Female subject of childbearing potential using a highly efficient method of contraception OR female subjects of non-childbearing potential (permanently sterilized or post-menopausal [i.e. at least 12 consecutive months with amenorrhea without other known or suspected medical cause])
    ii. Male subject, and their female partner of childbearing potential, using a highly efficient method of contraception
    iii. Adequate contraceptive method defined as:
    a. A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner)
    OR
    b. The use of two methods of contraception (e.g. one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive [e.g. combined oral contraceptives, patch, vaginal ring, injectables and implants])
    7. Willingness and capability of complying with all study procedure requirements, as per the Investigator’s judgment
    E.4Principal exclusion criteria
    1. Current forms of psoriasis other than chronic plaque-type
    2. Current drug induced psoriasis
    3. History of hypersensitivity or allergy to the IMP or its excipients
    4. History of recurrent or medically important infections in the last 12 months that required medical/pharmaceutical intervention
    5. Clinically significant candida infection requiring systemic treatment within last 12 months
    6. Clinically significant skin infection with Staphylococcus aureus requiring systemic treatment within the last 12 months
    7. History of or any signs of lymphoproliferative disease, or a known malignancy or a history of malignancy within the previous 5 years (with the exception of basal cell or squamous cell carcinoma of the skin that had been fully excised with no evidence of recurrence)
    8. History of or current relevant autoimmune diseases other than psoriasis
    9. Diagnosis of Inflammatory Bowel Disease requiring treatment within the past 12 months
    10. Clinically significant heart condition which is not well controlled by current therapy, as assessed by the Investigator
    11. Underlying conditions which in the opinion of the Investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
    12. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the subject from adhering to the protocol or completing the study per protocol
    13. Current uncontrolled arterial hyper- or hypotension as evidenced by measured blood pressure values at Screening (after 15 min in supine position) outside the following ranges:
    -Systolic blood pressure: ≤90 mmHg or > 140 mmHg
    -Diastolic blood pressure: ≤50 mmHg or ≥95 mmHg
    14. Alanine aminotransferase or aspartate aminotransferase level ≥2.5 times the upper limit of normal at Screening
    15. Estimated Glomerular Filtration Rate <60 mL/min/1.73 m2 according to the CKD-EPI equation
    16. Positive test for subclinical / latent tuberculosis infection at Screening
    17. Positive test for human immunodeficiency virus, hepatitis B or hepatitis C at Screening:
    -HIV antibody (any test)
    -HBV surface antigen
    -Anti-HCV antibody
    18. Women who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding
    19. Evidence or indication of drug and/or alcohol abuse or dependence, according to the judgment of the Investigator
    20. Recent previous exposure to systemic psoriasis treatments within the following weeks prior to randomization: biological therapies (e.g. ustekinumab [16 weeks], adalimumab, alefacept, infliximab [12 weeks], etanercept [6 weeks], experimental biological products [6 months or 5 half-lives, whichever is longer]); immunosuppressive agents [4 weeks]; other medications affecting the immune function [4 weeks]; rituximab [52 weeks]; or other systemic psoriasis treatments [4 weeks]
    21. Treatment with topical agents that could affect psoriasis activity within 2 weeks of randomization. Topical therapy in selected areas such as the groin or axillar region with mild corticosteroids (European classification 1) is not excluded
    22. Prior exposure to systemic psoriasis treatments with anti-IL-17 biological therapies
    23. Photochemotherapy, phototherapy, or blue light therapy within 4 weeks of randomization
    24. Use of any prescribed or non-prescribed systemic or topical medication within 7 days of randomization that, in the opinion of the Investigator, may affect the study assessments or compromise safety
    25. Participation in another clinical trial within 30 days prior to Screening or administration of another IMP within 5 half-lives (for biologics, 6 months or 5 half-lives) prior to randomization, whichever is longer
    26. Have had a live vaccination within 12 weeks of randomization, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study, or have participated in a vaccine clinical study within 12 weeks of randomization
    27. Inability or unwillingness to limit ultraviolet light exposure during the course of the study
    28. Subject was previously randomized in the current study
    29. Subject is an Investigator, study site or Sponsor personnel directly affiliated with this study and/or their immediate families
    30. Subject is considered to belong to a vulnerable population
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects at each dose level who achieve a ≥90% reduction in PASI score (PASI 90
    response) at Week 12 of the Core study
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    1. Safety as assessed by vital signs, physical examination, safety laboratory and adverse events (AEs)
    2.1. Difference to placebo per dose level in the proportion of subjects achieving PASI 50, 75, 90 and 100 responses, absolute PASI score < 3 and ≤1, sPGA of 0 or 1 and ≥2-point improvement from Baseline, DLQI of 0 or 1 after 12 weeks of treatment of the Core study
    2.2. Difference to placebo per dosing regimen in change from Baseline in absolute PASI score, sPGA, target nail NAPSI, DLQI, Pain-VAS and Itch-VAS after 12 weeks of treatment of the Core study
    3. Proportion of subjects per dosing regimen achieving PASI 90 response at Week 24 and 52 of the Core study
    4.1. Proportion of subjects per dosing regimen achieving PASI 50, 75, and 100 responses at Week 12, 24 and 52 of the Core study
    4.2. Proportion of subjects per dosing regimen achieving absolute PASI < 3 response at Week 12, 24 and 52 of the Core study
    4.3. Proportion of subjects per dosing regimen achieving absolute PASI ≤1 response at Week 12, 24 and 52 of the Core study
    4.4. Change from Baseline to Week 12, 24 and 52 of the Core study in PASI score
    4.5. Proportion of subjects per dosing regimen achieving sPGA of 0 or 1 and ≥2-point improvement from Baseline at Week 12, 24 and 52 of the Core study
    4.6. Change from Baseline to Week 12, 24 and 52 of the Core study in sPGA score
    4.7. Change from Baseline to Week 12, 24 and 52 of the Core study in target nail NAPSI score
    5.1. Proportion of subjects per dosing regimen achieving DLQI of 0 or 1 at Week 12, 24 and 52 of the Core study, compared to the proportion of subjects scoring DLQI 0 or 1 at Baseline (Visit 2)
    5.2. Proportion of subjects per dosing regimen achieving DLQI of ≤ 5 at Week 12, 24 and 52 of the Core study, compared to the proportion of subjects scoring DLQI ≤ 5 at Baseline (Visit 2)
    5.3. DLQI score at Week 12, 24 and 52 of the Core study compared to Baseline (Visit 2)
    5.4. Pain-VAS score at Week 12, 24 and 52 of the Core study compared to Baseline (Visit 2)
    5.5. Itch-VAS score at Week 12, 24 and 52 of the Core study compared to Baseline (Visit 2)
    6. ABY-035 PK exposure
    7. Levels of anti-ABY-035 antibodies in the blood

    Extension period
    1. Long-term safety and tolerability as assessed by vital signs, physical examination, safety laboratory and AEs
    2. Proportion of subjects per dosing regimen achieving PASI 90 responses at Week 24 and 52 of each year of the Extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260)
    3.1. Proportion of subjects per dosing regimen achieving PASI 50, 75, and 100 responses at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260)
    3.2. Proportion of subjects per dosing regimen achieving absolute PASI < 3 response at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260)
    3.3. Proportion of subjects per dosing regimen achieving absolute PASI ≤1 response at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260)
    3.4. Change from baseline to Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260) in PASI score
    3.5. Proportion of subjects per dosing regimen achieving sPGA of 0 or 1 and ≥2-point improvement from
    baseline at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260)
    3.6. Change from baseline to Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260) in sPGA score
    4.1. Proportion of subjects per dosing regimen achieving DLQI of 0 or 1 at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260), compared to the
    proportion of subjects scoring DLQI 0 or 1 at baseline.
    4.2. Proportion of subjects per dosing regimen achieving DLQI of ≤ 5 at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156, 180, 208, 232 and 260), compared to the
    proportion of subjects scoring DLQI ≤ 5 at baseline
    4.3. DLQI score at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128, 156,
    180, 208, 232 and 260) compared to Baseline
    4.4. Pain-VAS score at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128,
    156, 180, 208, 232 and 260) compared to Baseline
    4.5. Itch-VAS score at Week 24 and 52 of each year of the extension periods (study weeks; 76, 104, 128,
    156, 180, 208, 232 and 260) compared to Baseline
    5. Levels of anti-ABY-035 antibodies in the blood
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, 24, 52, 76, 104, 128, 156, 180, 208, 232 and 260
    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 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 of ABY-035
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned16
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last Subject Last Visit (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state100
    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)
    When subjects complete the study, continuing treatment according to clinical routine will be provided as judged by the Investigator or treating physician.
    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 Decision2017-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-03
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