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    Summary
    EudraCT Number:2020-003476-41
    Sponsor's Protocol Code Number:ANB019-206
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-003476-41
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind,
    Placebo-Controlled Study to Evaluate the Efficacy and
    Safety of ANB019 in the Treatment of Subjects with
    Ichthyosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of ANB019 in Subjects with Ichthyosis
    A.3.2Name or abbreviated title of the trial where available
    INSPIRE
    A.4.1Sponsor's protocol code numberANB019-206
    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 Address10770 Wateridge Circle, Suite 210
    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.3.1Product nameAnti-interleukin-36 receptor (IL-36R) monoclonal antibody
    D.3.2Product code ANB019
    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 INNanti-IL-36R monoclonal antibody
    D.3.9.2Current sponsor codeANB019
    D.3.9.4EV Substance CodeSUB33114
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Ichthyosis
    Rybia łuska
    E.1.1.1Medical condition in easily understood language
    The ichthyoses are a group of rare chronic genetic disorders that share characteristics of scaling and underlying skin inflammation to varying degrees
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of ANB019 compared with placebo as measured by IASI total score
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of ANB019 compared with placebo on ichthyosis signs and symptoms, and quality of life in subjects with ichthyosis.
    • To determine the safety of ANB019 in the treatment of ichthyosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subject aged 12 to 75 years (inclusive) at the time of signing the informed
    consent/assent.
    2. Confirmed diagnosis by genetic testing of ichthyosis of one of these subtypes:
    a) Congenital ichthyosiform erythroderma (autosomal recessive congenital ichthyosis [ARCI]);
    b) Epidermolytic ichthyosis;
    c) Netherton syndrome;
    d) Ichthyosis en confetti;
    e) Other subtypes may be included (only subtypes in which high levels of IL-36γ expression in skin
    were confirmed by a ribonucleic acid [RNA] analysis [eg, RNA sequencing {RNA-seq},
    polymerase chain reaction {PCR}] as part of other studies).
    Note: Confirmation of genetic subtype will be obtained prior to eligibility determination.
    3. IASI total score ≥ 18, erythema score ≥ 2 (moderate severity) in ≥ 1 body region and scaling score ≥
    2 (moderate severity) in ≥ 1 body region as evaluated by IASI, and BSA involved with ichthyosis of at
    least 50% at Day 1.
    4. Subject has been using an emollient (without pharmacological active ingredients) daily for at least 1
    week prior to Day 1 (except within 3 hours prior to the study visit) and agrees to continue using that
    same emollient daily at the same frequency throughout the study.
    5. Subject meets the following laboratory criteria at screening:
    a) Hemoglobin ≥ 90 g/L (≥ 9 g/dL);
    b) White blood cell count ≥ 3.0 × 109/L (≥ 3.0 × 103/µL);
    c) Platelets ≥ 100 × 109/L (≥ 100 × 103/µL);
    d) Serum creatinine <132.6 µmol/L (< 1.5 mg/dL);
    e) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 upper limit of
    normal (ULN);
    f) Total bilirubin ≤ 1.5 × ULN. Subjects with known Gilbert’s disease who have serum
    bilirubin < 3 × ULN may be included.
    6. Body mass index (BMI) within the range of 18 to 38 kg/m2, inclusive {BMI = weight (kg)/[height
    (m)]2}.
    7. No clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that
    would, in the opinion of the Investigator, put the subject at undue risk or interfere with
    interpretation of study results.
    8. Contraceptive use by men and 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 1 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 last study treatment administration and
    refrain from donating sperm during this period.
    b) Female subjects:
    i) A woman of childbearing potential (WOCBP) 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 Day 1 (see Appendix 1), is not breastfeeding, and agrees to follow
    the contraceptive guidance in Appendix 1 during the treatment period and for at least
    6 months after receiving the study treatment, and refrains 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 at
    Day 1 (eg, hormonal contraception should be initiated at least 48 days before Day 1).
    ii) A woman not of childbearing potential as defined in Appendix 1, must have a
    follicle-stimulating hormone (FSH) test confirming nonchildbearing potential.
    iii) An adolescent subject who experiences menarche during the trial will be considered a
    WOCBP and will be required to follow the contraceptive guidance for WOCBP in Appendix
    1 and undergo pregnancy testing as detailed in the SoA (Section 1.3).
    9. Subject is willing to participate and is capable of giving written informed consent, which must be
    personally signed and dated by the subject and obtained prior to any trial-related activities.
    Subjects who need to provide assent, as per local requirement, need to have their parent(s) or legal
    representative read and sign the informed consent form prior to any study-related procedures.
    Adolescent subjects who reach 18 years of age during the study must be reconsented as adults.
    10. Subject must be willing to comply with all study procedures and must be available for the duration
    of the study.
    E.4Principal exclusion criteria
    1. Concomitant dermatological or medical conditions that may interfere with the Investigators’ ability to evaluate the subject’s response to therapy.
    2. A subject with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
    3. Subject has a history of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric
    disease, or other major uncontrolled disease.
    4. Chronic or recurrent infectious disease, including but not limited to upper and lower respiratory infection within 6 months prior to screening.
    5. History or any evidence of active infection that required systemic treatment within 4 weeks of Day 1, excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled.
    6. Any factors that would predispose the subject to develop an infection in the Investigator’s opinion.
    7. Opportunistic infection or parasitic infections within 6 months prior to screening.
    8. Herpes zoster infection within 2 months prior to screening.
    9. Known or suspected autoimmune disorder
    10. History of known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status
    11. Any major surgery within 4 weeks of Day 1.
    12. History of cancer or lymphoproliferative disease within 5 years prior to Day 1.
    13. History of any significant drug allergy or reaction and reactivity to polysorbate-20, a component of ANB019 formulation, or the inactive ingredients.
    14. Subject has taken the following drugs within the specified period prior to Day 1:
    a) Topical medications within 2 weeks prior to Day 1.
    b) Topical agents or systemic agents that could affect pruritus within 2 weeks prior to Day 1.
    c) Oral sedative H1 antihistaminic (including but not limited to diphenhydramine) within 2 weeks prior to Day 1.
    d) Systemic therapy (including, but not limited to retinoids, cyclosporin, methotrexate,
    corticosteroids) or any other immunosuppressant or immunomodulation drugs within 4 weeks
    prior to Day 1.
    e) Previous treatment with anti-IL-36R, anti-IL-36, anti-tumor necrosis factor (TNF)/
    IL-12/IL-23/ IL-17, or any other mAbs within 12 weeks or 5 half-lives (whichever is longer) prior
    to Day 1.
    f) Any nonbiologic investigational drug within 4 weeks or 5 half-lives, whichever is longer prior to
    Day 1.
    g) Marketed or investigational biological agent within 12 weeks or 5 half-lives (whichever is
    longer) prior to Day 1.
    h) Antibiotic medication within 4 weeks (topical 1 week and systemic 4 weeks) prior to Day 1.
    i) Systemic antiviral medication within 4 weeks prior to Day 1.
    j) Live attenuated vaccine within 12 weeks prior to Day 1.
    15. Active TB or latent TB infection as indicated by a positive QuantiFERON®-TB Gold test at screening
    or within 6 months prior to screening (if the test is indeterminate, it can be repeated only once),
    chest X-ray, and/or clinical examination, or has had active TB disease at any time in the past.
    16. Clinically significant drug or alcohol abuse in the last year prior to Day 1, or other factors limiting
    the ability to cooperate and to comply with the study protocol, as determined by the Investigator.
    17. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the
    study period.
    18. Subject has any other physical, mental, or medical conditions, which, in the opinion of the
    Investigator, make study participation inadvisable or could confound study assessments.
    19. Subject has clinically significant abnormality on chest X-ray at screening or within 6 months prior to
    screening.
    20. Subject has any clinically significant abnormalities on 12-Lead ECG at screening.
    21. Subject has any evidence of clinically significant abnormality in urinalysis at screening as
    determined by the Investigator.
    22. Subject has a positive blood screen for hepatitis C antibody, antibodies to hepatitis B core antigens,
    hepatitis B surface antigen, or human immunodeficiency virus 1 and 2 antibodies.
    23. Subject is not able to tolerate SC drug administration.
    24. For subjects consenting to biopsies only:
    a) Subject has a history of an allergic reaction or significant sensitivity to lidocaine or other local
    anesthetics.
    b) Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites.
    c) Subject has taken anticoagulant medication, such as heparin, low molecular weight (LMW)
    heparin, warfarin, antiplatelets (except low-dose aspirin which will be allowed), within 2 weeks
    prior to Day 1, or has a contraindication to skin biopsies. Nonsteroidal anti-inflammatory drugs
    (NSAIDs) will not be considered antiplatelets and will be allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in IASI total score at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    - Percent change from Baseline in IASI total score at Week 16
    - Proportion of subjects achieving IASI50 at Week 16
    - Change and percent change from Baseline in IASI-E and IASI-S subscores at Week 16
    - Incidence of AEs, SAEs, and AEs leading to withdrawals, as well as changes in vital signs, clinical laboratory parameters (hematology, biochemistry, and urinalysis),
    and 12-lead ECGs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To test for immunogenicity to ANB019
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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 years1
    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 years1
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    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: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 24
    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 (Day 281/Week 40) or ET visit for final safety and
    EOS assessments. After this visit, subjects should be treated according to the clinical judgment of the
    subject’s physician. 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 Decision2021-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-11-19
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