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    Summary
    EudraCT Number:2017-004022-15
    Sponsor's Protocol Code Number:ANB019-003
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-01-27
    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 - PEI
    A.2EudraCT number2017-004022-15
    A.3Full title of the trial
    A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate the Efficacy and Safety of ANB019 in Subjects with Palmoplantar Pustulosis
    A.4.1Sponsor's protocol code numberANB019-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03633396
    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 SponsorAnaptysBio Inc
    B.1.3.4CountryUnited States
    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 supportAnaptysBio Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnaptysBio Inc
    B.5.2Functional name of contact pointAnaptysBio Clinical Trials Info
    B.5.3 Address:
    B.5.3.1Street AddressSuite 200, 10421 Pacific Center Court
    B.5.3.2Town/ citySan Diego, California
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018583626387
    B.5.6E-mailclinicaltrialinfo@anaptysbio.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.3.2Product code ANB019
    D.3.4Pharmaceutical form Solution for infusion
    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 INNanti-IL-36R monoclonal antibody
    D.3.9.2Current sponsor codeANB019
    D.3.9.3Other descriptive nameAlvarez 2
    D.3.9.4EV Substance CodeSUB33114
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    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) Yes
    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 infusion
    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
    Palmoplantar pustulosis (PPP)
    E.1.1.1Medical condition in easily understood language
    PPP is characterized by development of sterile pustules on palms and/or
    soles. It is persistent and painful, often resulting in significant functional
    impairment and diminished quality of life.
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037159
    E.1.2Term Psoriasis pustular
    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
    - To assess the efficacy of ANB019 in subjects with PPP compared with placebo as measured by proportion of subjects who achieve the Palmoplantar Pustulosis
    Psoriasis Area Severity Index 50 (PPPASI50).
    - To assess the safety and tolerability of ANB019 in subjects with PPP.
    E.2.2Secondary objectives of the trial
    - To determine the effect of ANB019 in subjects with PPP as measured by the PPPASI.
    - To determine the effect of ANB019 in subjects with PPP as measured by Palmoplantar Pustulosis Severity Index (PPSI).
    - To determine the proportion of subjects who achieved PPP disease clearance after administration of ANB019 as measured by the Palmoplantar Pustulosis (static)
    Investigator's Global Assessment (PPPIGA).
    - To determine the time to response with ANB019 in subjects with PPP.
    - To determine the relapse rate with ANB019 in subjects with PPP.
    - To evaluate the effect of ANB019 in subjects with plaque psoriasis at non-acral sites (if present) as measured by the Psoriasis Area Severity Index (PASI) and
    affected body surface area (BSA).
    - To evaluate the effect of ANB019 in subjects with pustular psoriasis at non-acral sites (if present) as measured by BSA.
    - To evaluate the effect of ANB019 on subject's quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects must be 18 to 75 years of age (inclusive), at the time of signing the informed consent.
    2. Clinically confirmed diagnosis of PPP with disease of sufficient Impact and severity requiring systemic therapy.
    3. Disease duration of at least 3 months prior to Screening.
    4. Present with active pustules on palms or/and soles at Screening and Baseline.
    5. At least moderate disease severity (score 3 = moderate) based on the PPPIGA (Appendix 9) at Screening.
    6. Subjects with or without a history of plaque psoriasis can be enrolled (number of subjects enrolled with plaque psoriasis should not exceed 50%).
    7. Meet the following laboratory criteria at Screening:
    • Hemoglobin ≥ 90 g/L (≥ 9 g/dL).
    • White blood cell count ≥ 3.0 × 10^9/L (≥ 3.0 × 10^3/μL).
    • Platelets ≥ 100 × 10^9/L (≥ 100 × 10^3/μL).
    • Serum creatinine <132.6 μmol/L (< 1.5 mg/dL).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
    ≤ 1.5 upper limit of normal (ULN),.
    • Total bilirubin ≤ 1.5 × ULN. Subjects with known Gilbert's disease who have serum bilirubin < 3 × ULN may be included.
    8. Body mass index (BMI) within the range of 18 to 36 kg/m2, inclusive {BMI = weight (kg)/[height (m)]2} and total body weight > 50 kg (110 lb).
    9. Subjects must be otherwise in a good health status as judged by the Investigator based on medical history, physical examination, ECG, hematology, chemistry,
    and urinalysis.
    10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical
    studies.
    Contraception and pregnancy:
    a) A male subject must agree to use contraception as detailed in Appendix 6 of this protocol during the treatment period and for at least 220 days (which includes
    the duration of relevant exposure plus the duration of sperm cycle) after the study treatment and refrain from donating sperm during this period.
    b) Female subjects:
    A female subject is eligible to participate if she has a negative serum pregnancy test (beta-human chorionic gonadotropin) at Screening and a negative Urine
    pregnancy test at Baseline (see Appendix 6), is not breastfeeding, and at least 1 of the following conditions apply:
    i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 6.
    OR
    ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 during the treatment period and for at least 6 months after
    receiving the study treatment and refrain from donating oocytes for assisted reproduction during this period. The female subject's selected form of
    contraception must be effective by the time the female subject enters into the study (eg, hormonal contraception should be initiated at least 48 days before
    Day 1).
    11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in
    this protocol.
    E.4Principal exclusion criteria
    1. Have other forms of psoriasis (eg, erythrodermic, guttate) except plaque psoriasis
    2. Have concomitant dermatological (eg, subcorneal pustular dermatosis, impetigo herpetiformis, acute generalized exanthematous
    pustulosis) or Medical conditions which may interfere with the Investigators' ability to evaluate the subject's response to therapy
    3. Have a history of clinically significant (as determined by the Investigator) cardiac, pulmonary, neurologic, gastrointestinal,
    endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease (a poorly controlled medical condition, such as but not limited to, poorly controlled diabetes, unstable ischemic heart disease, uncontrolled Hypertension (for definition of ranges see protocol) and moderate to severe heart failure [New York Heart Association Class III/IV])
    4. History of chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection (eg, sinusitis, bronchitis,
    and bronchiectasis), urinary tract infection (eg, recurrent pyelonephritis), and skin infection (eg, abscesses, infected skin wounds, or ulcers) within 24
    months prior to Screening. Subjects with a history of localized oral or genital herpes simplex that, in the opinion of the Investigator, is well controlled will be eligible for study participation
    5. History of a serious infection (eg, hepatitis, pneumonia) that led to hospitalization or treatment with IV antibiotics or antiviral treatment for an infection within 3 months prior to Screening or any recent infection requiring systemic antibiotic or systemic antiviral treatment within 4 weeks of Baseline
    6. History or any evidence of active infection within 4 weeks of Baseline (eg, bronchopulmonary, urinary, or gastrointestinal), excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled
    7. Presence of any factors that would predispose the subject to develop infection (eg, rectal fissures, poor dentition)
    8. History of an opportunistic infection (eg, Pneumocystis carinii, aspergillosis, or mycobacteria other than tuberculosis [TB]), parasitic infections such as, but not exclusively, helminths, protozoa, Trypanosoma cruzi within 6 months prior to Screening
    9. History of a herpes zoster infection within 2 months prior to Screening
    10. Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, or other severe forms of atopy, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment
    11. Any history of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy)
    12. Any major surgery within 4 weeks of study treatment administration
    13. Malignancy or history of malignancy within 5 years prior to Screening, except for treated basal cell or squamous cell in situ carcinoma of the skin or squamous cell carcinomas deemed by the Principal Investigator to be fully treatable
    14. History of any significant drug allergy or reaction (such as anaphylaxis or hepatotoxicity) and reactivity to polysorbate 20, a component of ANB019 formulation, or the inactive ingredients (excipients)
    15. Have taken the following drugs within the specified period prior to Screening or Baseline (Day 1): see protocol section 5.2
    16. History of active TB or latent TB infection (for details refer to protocol section 5.2)
    17. History of drug, alcohol, or other substance abuse, or other factors limiting the ability to cooperate and to comply with the study protocol, as determined by the Investigator
    18. Pregnant or lactating females, or females who intend to become pregnant during the study period
    19. Donation of blood to a blood bank or in a clinical study (except a Screening visit) within 4 weeks of study treatment Administration (within 2 weeks for plasma only)
    20. Blood transfusion within 4 weeks of study treatment Administration (Day 1)
    21. Any other physical, mental, or medical conditions, which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
    22. Clinically significant abnormality on chest X-ray at Screening or within 12 months prior to Screening
    23. Any clinically significant abnormalities on 12-Lead ECG at Screening
    24. Evidence of clinically significant abnormality in urinalysis as determined by the Investigator
    25. Positive blood screen for hepatitis C antibody, hepatitis B Surface antigen, or human immunodeficiency virus 1 and 2 antibodies
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoint:
    Proportion of subjects achieving PPPASI50 at week 16

    Safety endpoints:
    - Assessment of AEs
    - Potentially significant and clinically important AEs, adverse event of special interests (AESIs), SAEs, and AEs leading to withdrawal
    - Physical examinations.
    - Vital signs.
    - 12-Lead ECG.
    - Clinical safety laboratory tests (hematology, biochemistry, and urinalysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy endpoint:
    week 16 = Day113

    Safety endpoints listed (details see schedule of activities section 1.3 protocol):
    Day 1, 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 113, 141, 169,197,218
    E.5.2Secondary end point(s)
    - Proportion of subjects achieving PPPASI50 and PPPASI75 at all study center visits.
    - Change from Baseline in PPSI score at all study center visits.
    - Change in PPPIGA score at all study center visits.
    - Proportion of subjects with clear or almost clear assessment score on PPPIGA at all study center visits.
    - Change in fresh and total pustule count on palms and soles at all study center visits.
    - Time to response defined as time to achieve 75% reduction in fresh pustule count.
    - Relapse rate defined as return to Baseline in fresh pustule count.
    - Change in PASI score and affected BSA at all study center visits, if plaque psoriasis is present at non-acral sites.
    - Improvement in pustular psoriasis at non-acral site BSA (if present) at all study center visits.
    - Change in clinical scores of Palmoplantar Pustulosis Quality of Life Instrument (PPPQLI), Dermatology Life Quality Index (DLQI), and Patient Assessment of
    Palmoplantar Pustulosis Disease Activity at all study center visits.
    - Presence of anti-drug antibodies
    - PK and Skin biopsies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 113, 141, 169
    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 No
    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
    immune Response to ANB019 in subjects with PPP
    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 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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Canada
    Germany
    Poland
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 59
    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)
    All subjects will return to the study center for the EOS (Week 31) or Early Termination (ET) visit for final safety and EOS assessments. After this visit, subjects should be treated according to the Investigator's clinical judgment. Care after EOS/ET will not be provided by AnaptysBio Inc.
    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 Decision2020-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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