Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002539-14
    Sponsor's Protocol Code Number:ANB020-002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-002539-14
    A.3Full title of the trial
    Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity upon House Dust Mite Skin Challenge in Patients Suffering from Moderate to Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the effect of ANB020 or placebo in patients with moderate to severe Atopic Dermatitis when exposed to House Dust Mites.
    A.4.1Sponsor's protocol code numberANB020-002
    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 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 number+18583626387
    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 ANB020
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanti-IL-33 monoclonal antibody
    D.3.9.2Current sponsor codeANB020
    D.3.9.3Other descriptive nameHumanized immunoglobulin subtype G1/kappa monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis is a form of eczema. It is a condition that causes the skin to become itchy, red, dry and cracked. It can affect any part of the body.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    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 measure the decrease of cytokines within interstitial fluid, where saline and house dust mite (HDM) have been administered, in patients receiving ANB020 compared to placebo.
    • To assess the effect of ANB020 on differential white blood cell (WBC) counts.
    • To assess the safety and tolerability of single dose administration of ANB020 in patients with atopic dermatitis (AD).
    E.2.2Secondary objectives of the trial
    • To assess the effect of ANB020 on serum cytokines.
    • To compare the changes in urticarial manifestation 0.5 hours after HDM challenge between patients receiving placebo and then ANB020.
    • To describe the limited pharmacokinetics (PK) of ANB020 following a single, intravenous (IV) dose.
    • To assess the activity of ANB020 after single dose administration on clinical scores such as the Eczema Area Severity Index (EASI), Investigator’s Global Assessment (IGA), Scoring Atopic Dermatitis (SCORAD), Dermatology Quality Life Index (DLQI), 5D Itch Score, and use of topical corticosteroids in patients with moderate to severe AD over a period of 8 weeks after administration of the IP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients with age >18 years and able to give informed consent.
    • Patients with a confirmed clinical diagnosis of AD based on the Hanifin/Rajka criteria.
    • The EASI score ≥14 at screening to reflect moderate to severe.
    • Patients with a confirmed positive response to a skin HDM challenge.
    • BMI of 18 to 32 kg/m2 (inclusive) and total body weight >50 kg.
    • Willing and able to comply with the study protocol requirements, in the Investigator’s opinion, including applying topical corticosteroid ointment and emollient as specified by the protocol.
    • Have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the Investigator and staff.
    • Female patients of childbearing potential must have a negative pregnancy test at screening and Day 1, must not be lactating, or intend to become pregnant during the study period, and be surgically sterile or using an acceptable method of contraception throughout the study and for 8 weeks after the last dose of the IP. Postmenopausal patients defined as 1) aged over 45 years with at least 1 year of amenorrhea and levels of follicle stimulating hormone over 20 UI/L or 2) aged over 50 years with at least 1 year of amenorrhea.
    • Male patients must be willing to use contraception during the entire study period.
    E.4Principal exclusion criteria
    • Have concomitant dermatological or medical condition(s) which may interfere with the Investigator’s ability to evaluate the patient's response to the IP.
    • Have applied any topical medication (including corticosteroids, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, and other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days before screening.
    • Have received antibiotic treatment within 2 weeks before screening.
    • Have received systemic treatment for AD (including systemic corticosteroids, non steroidals, immunosuppressants or immunomodulating drugs, antihistamines, or treatment with light or use of a tanning booth) within 4 weeks before screening.
    • Have received any investigational drug or been part of any interventional clinical study within a period of 3 months or 5 half-lives (whichever is longer) before screening.
    • Have a history of hypersensitivity or allergic reactions to polysorbate 80 a component of ANB020 formulation or the inactive ingredients (excipients).
    • Have a history of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
    • History of drug, alcohol or other substance abuse, or other factors limiting the ability to cooperate and to comply with the study protocol.
    • Hypersensitivity to topical corticosteroid or to any other ingredients contained in the topical corticosteroid product used in the study.
    • Use of any over the counter or complementary medicines, within 7 days before screening.
    • Clinical diagnosis of bacterial infections of the skin, including impetigo or abscesses which meet any of the following criteria: hospital admission within 4 weeks of screening; received IV, oral or topical antibiotics within 2 weeks of screening.
    • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV 1 and 2 antibodies.
    • Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments.
    • History of parasitic infections within 12 months before screening.
    • Receipt of a live attenuated vaccine within 4 weeks before screening.
    • Planned surgery during the study.
    • History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease.
    E.5 End points
    E.5.1Primary end point(s)
    1. Cytokine in blister fluid after HDM skin challenge, including, but not limited to IL-4, IL-5, IL-13, and IL-33.

    2. Differential WBC counts will be measured to monitor peripheral cell populations.

    3. Safety and Tolerability:
    •Assessment of AEs
    •Potentially significant and clinically important AEs, SAEs, AEs of special interests, and AEs leading to withdrawal
    •Physical examinations
    •Vital signs
    •Clinical safety laboratory tests (haematology, biochemistry, and urinalysis)
    •Electrocardiogram (ECG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Cytokine in blister fluid after HDM skin challenge, including, but not limited to IL-4, IL-5, IL-13, and IL-33: At Day 5, 24 hours after placebo / HDM challenge and at Day 12, 24 hours after ANB020 / HDM challenge.

    2. Differential WBC counts: Day 5 and 12.

    3. Safety and Tolerability:
    •Assessment of AEs: Throughout the study period.
    •Physical examinations: Screening, Days 1, 8, 15 and 64.
    •Vital signs and clinical safety laboratory tests (haematology, biochemistry, and urinalysis): Screening, Days 1, 8, 15, 22, 36 and 64.
    •Electrocardiogram: Screening and Day 64.
    E.5.2Secondary end point(s)
    1. Urticarial manifestation 0.5 hours after HDM skin challenge between placebo and ANB020.
    2. Circulating cytokines including, but not limited to IL-4, IL-5, IL-13, IL-33, and sST2.
    3. Clinical scores for EASI, IGA, SCORAD, DLQI, and 5D Itch Score.
    4. Patient diary data of corticosteroid usage.
    5. Determination of ANB020 in human serum for PK assessment. Where possible, the following PK parameters will be determined for ANB020 after a single IV infusion; maximum observed concentration and time to maximum observed concentration
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Urticarial manifestation 0.5 hours after HDM skin challenge between placebo (Day 4) and ANB020 (Day 11).
    2. Circulating cytokines: Days 1, 5, 8 and 12.
    3. Clinical scores for EASI, IGA, SCORAD, DLQI, and 5D Itch Score: Screening, Days 1,8,15,22, 36 and 64.
    4. Patient diary data of corticosteroid usage: Throughout study duration.
    5. PK assessment: Screening, Days 8, 11 and 12.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days78
    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: 12
    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.4.1In the member state12
    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 Decision2016-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-04
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 19:48:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA