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    Summary
    EudraCT Number:2020-003143-28
    Sponsor's Protocol Code Number:BB-2293-101b
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-08-06
    Trial 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 number2020-003143-28
    A.3Full title of the trial
    A First-in-Human, Double-Blind, Randomised, Vehicle Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis (AD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A First-in-Human trial to investigate how safe, tolerable, effective and how the body handles BEN2293 in patients who have mild to moderate eczema.
    A.4.1Sponsor's protocol code numberBB-2293-101b
    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 SponsorBenevolentAI Bio Limited
    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 supportBenevolentAI Bio Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBenevolentAI Bio Limited
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address4-8 Maple Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 5HD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailleo.james@benevolent.ai
    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 BEN2293
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEN2293
    D.3.9.2Current sponsor codeBEN2293
    D.3.9.3Other descriptive nameBEN-00002293
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 BEN2293
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEN2293
    D.3.9.2Current sponsor codeBEN2293
    D.3.9.3Other descriptive nameBEN-00002293
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOintment
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild-Moderate Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Eczema
    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 10003639
    E.1.2Term Atopic dermatitis
    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
    The primary objective of this study is to assess the safety and tolerability of BEN2293, administered as multiple topical doses to increasing body surface areas, in patients with mild to moderate AD.
    E.2.2Secondary objectives of the trial
    • To investigate the plasma PK of BEN2293 and metabolite BEN6403 following multiple topical doses to mild to moderate AD patients.
    • To investigate the effect of BEN2293 on pruritus in patients with mild to moderate AD.
    • To investigate the effect of BEN2293 on AD in patients with mild to moderate AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females with mild to moderate atopic dermatitis (based on vIGA) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments.
    3. Patient is aged between18 to 65 years, inclusive.
    4. Patient has a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
    5. Body weight of ≥50 kg.
    6. History of atopic dermatitis for at least 6 months diagnosed by a dermatologist or GP.
    8. A Validated Investigator’s Global Assessment (vIGA) score of 2 (mild) to 3 (moderate) at both Screening and Day -1.
    9. Atopic dermatitis affecting between ≥5% to ≤15% Body Surface Area (BSA) of treatable skin (not including face, scalp, hands or soles of feet) at Screening and Day -1 for Cohorts 1 and 2, and between ≥5% to ≤30% BSA of treatable skin (not including face, scalp, hands or soles of feet) at Screening and Day -1 for subsequent cohorts.
    10. History of AD associated pruritus with an itch score (NRS) of ≥4. The mean of the pruritus NRS scores (worst itch over the last 24 hours) obtained on Day -3, Day -2 and Day -1 during the emollient only washout phase will be used to assess inclusion.
    11. Patients must be willing to stop applying their daily emollients and instead use the study emollient from at least 7 days prior to Day 1 and throughout their participation in the study.
    12. Males must use a condom during the trial and for 3 months after their final dose study medication, In addition, their female partner of childbearing potential must be established on an additional method of highly effective contraception prior to dosing until 3 months following final dosing.
    13. Female patients of childbearing potential must be established on a highly effective method of contraception prior to dosing until 3 months after last dose in combination with male partner’s use of a condom during the trial and for 3 months after the last dose. Patients must have a negative pregnancy test at Screening and Day 1.
    14. Participant has a minimum of one atopic dermatitis area in a site suitable for biopsy.
    E.4Principal exclusion criteria
    1. Atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per investigator’s discretion.
    2. Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IMP application sites.
    3. Patients who have AD lesions affecting >3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet).
    4. Patients who have a source of itch solely or significantly from untreatable areas (face, scalp, genitals, palms of hands or soles of feet ).
    5. Have concomitant skin disease or infection (e.g. acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments.
    6. Patients who are excessively hirsute in areas of skin to be dosed with study ointment.
    7. Patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to Day -1 and throughout the duration of the study.
    12. Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti HCV), human immunodeficiency virus I and II (anti-HIV I/II) or SARS-CoV-2 at Screening or Day -1.
    17. Supine SBP <90 mmHg >140 mmHg , or DBP <50 mmHg or >90 mmHg after 5 minutes supine and after 3 minutes standing. One repeat is allowed if values are out of range.
    22. Patients who have received phototherapy (e.g. UVA, UVB or PUVA therapy), or systemic therapy (e.g., immunosuppressants [such as cyclosporine, azathioprine, methotrexate], cytostatics) known or suspected to have an effect on AD, within 3 months prior to screening. All biologics must not have been used within 6 months prior to screening.
    23. Patients who have received systemic corticosteroids (e.g. oral, intravenous, intraarticular, rectal) within 8 weeks prior to screening. Patients on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal corticosteroids may participate.
    24. Patients treated with oral antihistamines within 7 days of screening; intranasal steroid, antihistamine or sodium cromoglycate sprays for the treatment of allergic rhinitis are acceptable.
    25. Patients treated with topical calcineurin inhibitors within 1 month of screening.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events
    - Local tolerance assessments, vital signs, 12-lead ECG, laboratory safety tests (clinical chemistry, haematology and urinalysis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Day (-28) to 14 days post last dose
    - Maximum evaluated days at Screening, Days 1, 2, 3, 5, 7 and 14. On selected days, these will be measured at pre-dose, 1, 2, 4, 8, 12 and 24 hours post dose
    E.5.2Secondary end point(s)
    Secondary PK end points:
    • Plasma concentration-time profiles and PK parameters for BEN2293 and BEN6403 including Cmax, tmax, t1/2, area under the plasma concentration vs. time curve (AUC) over a dosing interval (AUCĪ„).
    • Accumulation ratio.
    Secondary efficacy endpoints:
    • Time to significant itch reduction.
    • Time to itch resolution.
    • Fraction of patients achieving significant itch reduction.
    • Fraction of patients achieving itch resolution.
    • Change from baseline in Duration of Itching
    • Change from baseline in the Numerical Rating Score (NRS) for Pruritus (Worst Itch over 24 hours).
    • Change from baseline in the NRS for Pruritus (Current Itch) .
    • Change from baseline in the Eczema Area and Severity Index (EASI) score.
    • Number of patients achieving improvement in EASI score.
    • Change from baseline in body surface area (BSA) affected by AD in treated area(s).
    • Change from baseline in Validated Investigators Global Assessment (vIGA) Score.
    • Change from baseline in Patient Oriented Eczema Measure (POEM).
    • Change from baseline in Dermatology Life Quality Index (DLQI).
    • Change from baseline in EQ-5D.
    • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS).
    • Change from baseline in Insomnia Severity Index ([ISI] for Part A, Cohorts 3 and 4 and Part B only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK assessments:
    - Blood samples: on Days 1, 2, 3, 5, 7, 8 and 14 and at follow up visit (14/15 days post last dose). On selected days, these would be measured at predose, 1, 2, 4, 6, 8, 11, 12, 14 and 24 hours postdose.
    - Urine samples: on Day 7 at 0-24 hours post dose.

    Efficacy assessments:
    - Numerical Rating Score (NRS) for Pruritus: predose, Day 1, 2, 3, 5, 7, 8 and 14, and at follow-up after last dose
    - Current itch NRS on Day 1 at predose, and 2, 4, and 8 hours postdose
    - EASI and vIGA: predose, Days 5, 7, 11, 14 and 21 and at follow-up post last dose
    - POEM, PROMIS and DLQI: predose, and at Days 7, 14 and at follow-up post last dose
    - EQ-5D: predose and at Day 14
    - ISI: predose, Day 14 and at follow-up post last dose
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    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 trial8
    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 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 Patient Last Visit (LPLV)
    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 months6
    E.8.9.1In the Member State concerned days
    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: 128
    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 state130
    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 Decision2020-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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