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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43206   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002836-18
    Sponsor's Protocol Code Number:AK801
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002836-18
    A.3Full title of the trial
    A Phase IIa open label single arm study of safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical study to investigate if rVA576 is safe and has an effect on patients who have mild or moderate Bullous Pemphigoid (a blistering disorder where the skin forms tense blisters)
    A.4.1Sponsor's protocol code numberAK801
    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 SponsorAkari Therapeutics Plc.
    B.1.3.4CountryUnited Kingdom
    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 supportAkari Therapeutics Plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkari Therapeutic Plc
    B.5.2Functional name of contact point24 hour medical cover
    B.5.3 Address:
    B.5.3.1Street Address75-76 Wimpole Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447387107750
    B.5.6E-mailPaulatsya.Joshi@akaritx.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 namerVA576
    D.3.4Pharmaceutical form Powder for 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 INNrVA576
    D.3.9.2Current sponsor coderVA576
    D.3.9.4EV Substance CodeSUB182098
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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
    Mild to Moderate Bullous Pemphigoid
    E.1.1.1Medical condition in easily understood language
    Mild to Moderate Bullous Pemphigoid, an acute or chronic autoimmune skin disease, involving the formation of blisters at the space between the epidermis and dermis skin layers.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10006567
    E.1.2Term Bullous pemphigoid
    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
    The primary objective of the study is to assess the safety of rVA576 in adult subjects with mild to moderate BP.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of rVA576 and its effect on the quality of life of adult subjects with mild to moderate BP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male or female ≥18 -old patients
    2. Subject with newly presenting mild to moderate BP not on any current systemic corticosteroid or immunomodulator treatment. (Subjects on topical corticosteroids will stop use of these on or before Day1)
    3. BPDAI global score at Screening of 10-56 (≥ 10 but <56)

    4. Subjects with a relapse of mild to moderate BP are eligible if their disease was quiescent without any systemic treatment for at least 2 months before the current relapse.

    5. Cutaneous BP per standard diagnostic criteria:
    a. Clinical presentation (cutaneous blistering and/or itchy dermatosis),
    AND
    b. Direct immunofluorescence (DIF) studies performed on erythematous perilesional skin collected approximately 1 cm away from a fresh blister, an erosion or papule showing linear (n-serrated) deposition of IgG and/or C3 along the epidermal basement membrane zone,
    AND/OR
    Indirect immunofluorescence (IIF) studies performed with patient serum on 1.0M NaCl human salt split skin, showing IgG along the roof of the blister.

    6. Karnofsky performance status > 60%
    7. Adequate cardiac, pulmonary, renal, hepatic, neurological and psychiatric function as determined by the Investigator and demonstrated by screening laboratory evaluations, vital sign measurement, ECG recording and physical examination results.
    8. Woman of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative serum pregnancy test at screening and a negative urine pregnancy test per the schedule of visits. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of amenorrhea or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks previously.
    9. Males with a childbearing potential partner of must agree to use effective contraception consistently OR have had a vasectomy
    10. Willing and able to adhere to the study visit schedule and other protocol requirements including self-injection.
    11. Willing and able to provide voluntary written informed consent.
    12. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the applicable guidelines and local standard of care of the PI at the trial site
    E.4Principal exclusion criteria
    Disease related (BP) Exclusion criteria
    1. Patients with severe BP where severe disease is defined as global BPDAI ≥ 56.
    2. Patients with refractory BP. Refractory BP may be defined as failure or loss of response to maximal doses of topical or oral steroids.
    3. Suspected drug induced BP.
    4. Concomitant skin conditions preventing physical evaluation of BP.

    rVA576 and Mometasone related exclusion criteria
    5. Participation in a clinical trial of an investigational product within 6 weeks of screening.
    6. Known hypersensitivity to tick or to rVA576 and any of its excipients.
    7. BP patients on systemic corticosteroid or systemic immunomodulator treatment (including azathioprine, dapsone, rituximab etc).
    8. Treatment with any biologics (e.g. etanercept, adalimumab, ustekinumab, infliximab, intravenous immunoglobulins (IVIG) and rituximab or other anti-CD20 therapies) within its 5 half-lives from screening.
    9. Known hypersensitivity to mometasone furoate or to other corticosteroids or to any of the excipients in mometasone furoate
    10. Received rVA576 or any other recognised systemic medications for the treatment of the current episode of BP prior to study entry. Prior topical treatment with corticosteroids is permitted. This must be discontinued and study medications started on Day 1

    General Exclusion Criteria
    11. Patients with severe medical or surgical conditions at screening or baseline including, but not limited to cardiac, respiratory, renal, hepatic haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, psychiatric, or any other severe acute or chronic medical condition that may increase the risk associated with study participation/treatment or may interfere with the interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for study entry.
    12. Presence of any malignancy that has been under active treatment or in previous 5 years with the exception of patients with removal of uncomplicated basal cell carcinoma or cutaneous squamous cell carcinoma, who may take part in the study.
    13. Congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, organ transplantation).
    14. Clinically significant vital sign measurements or ECG findings as determined by the Investigator.
    15. Clinically significant abnormal laboratory test results including but not limited to:
    • Haemoglobin level <10.0 g/dL
    • White blood cell count < 3 x 103/μL
    • Lymphocyte count < 0.5 x 103/μL
    • Platelet count <100 x 10*9 /L or >1200 x 10*9/L
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x the upper limit of normal (ULN)
    • Alkaline phosphatase >3 x ULN
    • Serum creatinine >2 x ULN
    16. Active or recent history of clinically significant infection within 1 month of screening.
    17. Pregnant or breast-feeding, or planning to become pregnant during the study.
    18. Evidence of an active disease of hepatitis B (HBsAg positive or HBcAb positive) or hepatitis C (HCV ab positive), CMV (IgM positive) or human immunodeficiency virus (HIV) infection (HIV1/2 Ab positive
    19. Active abuse of alcohol or drugs.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants reporting grade 3, 4 and 5 adverse events, which are related/possibly related to rVA576 during the treatment period.

    The Common Terminology Criteria for Adverse Events (CTCAE v4.03) will be used to grade adverse events. At each study visit, participants will be questioned about adverse events they have experienced since the last study visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Percentage change in BPDAI between baseline (Day1) and Day 42
    - Mean absolute change in BPDAI between Day 1(baseline) and Day 42. compared to Day 1
    - Proportion of patients whose BPDAI score decreases by 4 or more points between baseline (Day 1) and Day 42.
    - Proportion of patients whose BPDAI score increases by 3 or more points between baseline (Day 1) and Day 42.
    - Mean change in Dermatology Life Quality Index (DLQI) between baseline (Day 1) and Day 42
    -Mean change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) baseline (Day 1) and Day 42
    E.5.2Secondary end point(s)
    • Mean absolute change in BPDAI activity scores between Day 1(baseline) and Day 42
    • Proportion of patients whose BPDAI activity score decreases by 4 or more points between baseline (Day1) and Day 42.
    • Proportion of patients whose BPDAI activity score increases by 3 or more points between baseline (Day1) and Day 42.
    • Mean absolute change in BPDAI pruritus index between Day 1 (baseline) and Day 42
    • Mean Change in DLQI between baseline (Day 1) and Day 42
    • Mean Change in TABQOL between baseline (Day 1) and Day 42
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Percentage change in BPDAI between baseline (Day1) and Day 42
    -Mean absolute change in BPDAI between Day 1(baseline) and Day 42
    -Proportion of patients whose BPDAI score decreases by 4 or more points between baseline (Day1) and Day 42.
    -Proportion of patients whose BPDAI score increases by 3 or more points between baseline (Day1) and Day 42.

    -Mean Change in DLQI between baseline (Day 1) and Day 42
    -Mean Change in TABQOL between baseline (Day 1) and Day 42
    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 No
    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 No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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 days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 9
    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)
    Normal standard of treatment
    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 Decision2018-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-29
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