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    Summary
    EudraCT Number:2017-000064-15
    Sponsor's Protocol Code Number:AK601
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-28
    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 number2017-000064-15
    A.3Full title of the trial
    A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Safety and Efficacy of Coversin in adult aHUS subjects
    A.4.1Sponsor's protocol code numberAK601
    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 Therapeutics, Plc
    B.5.2Functional name of contact point24 Hour Medical Contact
    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+44778 950 4390
    B.5.6E-mailbrihad@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 nameCoversin
    D.3.2Product code rVA576
    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 INNCoversin
    D.3.9.2Current sponsor coderVA576
    D.3.9.3Other descriptive nameCOVERSIN
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atypical haemolytic uraemic syndrome (aHUS)
    E.1.1.1Medical condition in easily understood language
    Atypical haemolytic uraemic syndrome (aHUS)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10018932
    E.1.2Term Haemolytic uraemic syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of Coversin in adult subjects with aHUS.
    E.2.2Secondary objectives of the trial
    1.Evaluate efficacy based on complete Thrombotic Micro An-giopathy (TMA) response, haematological response and TMA event rate.
    2.Evaluate additional efficacy end points, such as the effect of Coversin on haematological and renal function over study period.
    3.Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of Coversin in subjects with aHUS.
    4.Determine the effective dose (ED) and frequency of dosing for the treatment of aHUS.
    5.Evaluate safety of Coversin in aHUS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.18 years and older at the time of consent.
    2.LDH at screening or at the onset of the current aHUS episode was ≥ 1.5 ULN.
    3.Platelet count at screening or at the onset of the current aHUS episode < 150 X 10*9/L.
    4.Evidence of AKI as per KDIGO guidelines [1]. (Increase in SCr by ≥ 0.3 mg/dl (26.5 µmol/l) within 48 hours; or Increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, OR Urine volume 0.5 ml/kg/h for 6 hours.
    5.Males and females of childbearing potential must agree to use an adequate method of contraception. Females will have a negative serum pregnancy test before entry to the study and throughout the study.
    6.The patient has given voluntary written informed consent.
    7. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the KDIGO guidelines and local standard of care of the PI at each trial site.
    E.4Principal exclusion criteria
    1.Thrombotic Thrombocytopenic Purpura (TTP), defined as ADAMTS13 activity <10% from an historical observation (prior to initiation of Plasma Therapy) or as tested at the screening visit.
    2.STEC HUS (known Shiga toxin positive or EHEC (En-terohaemorrhagic Escherichia coli)) positive cultures.
    3.HUS related to known HIV infection.
    4.Identified drug exposure-related HUS.
    5.HUS related to bone marrow transplant (BMT).
    6.HUS related to Cobalamin (vitamin B12) deficiency.
    7.Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive.
    8.Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease.
    9.Unresolved meningococcal disease.
    10.Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome.
    11.Prior use of eculizumab (Soliris®) within 2 months of screening is prohibited.
    12.Exposure to any other investigational drug acting directly on the complement system within 5 half-lives of screening is prohibited.
    13.Chemotherapeutic agents within 3 months of enrolment in the study are prohibited.
    14.History of malignancy within 5 years of screening.
    15.Known sensitivity to the excipients of meningococcal vaccines, ciprofloxacin or any other antibiotic being administered for purposes of meningitis prophylaxis.
    16.Participation in other clinical trials within 4 weeks of signing the ICF.
    17.Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
    18.History of active systemic autoimmune diseases other than the target condition. Dermatologic diseases such as psoriasis will not be a reason for exclusion unless there are associated systemic symptoms such as arthritis.
    19.Any severe systemic disorder that could interfere with the evaluation of the study treatment (e.g. hepatic disease) that in the opinion of the Investigator would affect the outcome of the study or interfere with interpretation of results.
    20.Failure to satisfy the Investigator of fitness to participate for any other reason or any condition (e.g. severe depression or psychiatric disorder) which, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
    21.If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after last dose; or intending to donate ova during such period.
    22.If male, the subject intends to donate sperm during this study or for 90 days after last dose.
    23.The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g. spouse, parent, child, sibling) or may consent under duress.
    24. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to screening.


    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with Normal Platelets count at day 180 [ defined as Platelet count ≥ 150x10*9/L.

    Safety endpoints
    Safety analysis will be performed using the safety analysis set.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 180
    E.5.2Secondary end point(s)
    1.Complete TMA response with preserved renal function: Proportion of patients who achieve complete TMA response with preserved renal function, defined as hematologic normalization (platelet count ≥150 X 109/L and LDH ≤ ULN) and preservation of kidney function (<25% increase in SCr from baseline), confirmed by two or more consecutive measurements obtained four or more weeks apart.
    2.Complete TMA response with improved renal function: Proportion of Patients with Complete TMA response with improved renal function defined as normalization of haematological parameters (normalisation of platelet count and LDH≤ULN) and ≥ 25% improvement in SCr from baseline which
    was sustained for at least two consecutive measurements obtained at least four weeks apart from each other.
    3.Proportion of subjects with TMA event free status.
    4.(Dialysis events occurring within the 14 days after the first dose of IMP will not be considered as a new Treatment Period dialysis event. In addition, dialysis events that commence within the 14 days before the first dose of IMP and continue up to 14 days after the first dose of IMP will not be considered a new Treatment Period dialysis event).
    5.Time to complete TMA response with improved renal function.
    6.Platelet count change from baseline to the end of Day 180.
    7.Proportion of subjects with Hematologic Normalization defined as normalization of both platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart from each other.
    8.Proportion of subjects with normalisation of platelet count at Day 30, Day 90 and Day 180 defined as a platelet count ≥150 x 109/L.
    9.Improvement in renal function defined as a decrease in SCr over three consecutive measurements without the need for dialysis even if not within the normal range.
    10.Reduction in requirement for dialysis defined as proportion of patients who discontinued dialysis for a period of 12 consecutive weeks from those who required dialysis at inclusion.
    11.Major Adverse Vascular Events (MAVE) rate during the pre-treatment period versus rate after the first dose of Investigational Product.
    12.Safety for Coversin therapy as assessed by AEs, adverse events of special interest (AESIs, including serious infections, including Neisseria infections, malignancies and injection site reactions and hypersensitivity), serious adverse events (SAEs), vital signs, results of standard laboratory tests (clinical
    chemistry, haematology and urinalysis), and results of 12 lead electrocardiograms (ECGs).


    E.5.2.1Timepoint(s) of evaluation of this end point
    -Two consecutive measurements obtained at least four weeks apart from each other (TMA response).
    -Day 30, Day 90, Day 180 (platelet count).
    -Three consecutive measurements (renal function).
    -12 consecutive weeks (reduction of dialysis).
    -After first dose of IMP (MAVE).
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 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: 8
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    At the end of the treatment period, subjects who have completed the study and who will continue to benefit from Coversin, as determined by the Investigator, will be offered the chance to remain on Coversin and enter the Long-Term Safety and Efficacy Trial.
    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 Decision2017-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-04-17
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