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    Summary
    EudraCT Number:2020-004767-77
    Sponsor's Protocol Code Number:IM018-005
    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:2021-10-01
    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 number2020-004767-77
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blinded, Placebo-controlled, 5 Parallel-group Study of BMS-986166 or Branebrutinib for the Treatment of Patients with Moderate to Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Double-blind, placebo-controlled study of BMS-986166 or Branebrutinib in Patients with Moderate to Severe Atopic Dermatitis.
    A.4.1Sponsor's protocol code numberIM018-005
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-1220
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameS1P Receptor Modulator
    D.3.2Product code BMS-986166
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 2552370-62-2
    D.3.9.2Current sponsor codeBMS-986166
    D.3.9.3Other descriptive nameBMS-986166-04, S1Pr1, [(1R,3S)-1-Amino-3-{(6S)-6-[2-(2-methoxyphenyl)ethyl]-5,6,7,8-tetrahydro-2-naphthalenyl}cyclopentyl]methanol hydrochloride
    D.3.9.4EV Substance CodeSUB232658
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.3.1Product nameBranebrutinib
    D.3.2Product code BMS-986195
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBranebrutinib
    D.3.9.1CAS number 1912445-55-6
    D.3.9.2Current sponsor codeBMS-986195
    D.3.9.3Other descriptive nameBMS-986195-01, 4-[(3S)-3-(2-Butynoylamino)-1-piperidinyl]-5-fluoro-2,3-dimethyl-1H-indole-7-carboxamide
    D.3.9.4EV Substance CodeSUB181091
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Atopic Dermatitis.
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis is a chronic condition characterized by red, itchy, dry, bumpy patches of skin. Lesions are typically found in the hands, neck, upper chest, inner elbows, and backs of the knees.
    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
    - To evaluate the efficacy of BMS-986166 and of branebrutinib, each versus placebo at Week 16 in
    patients with moderate-to-severe Atopic Dermatitis.
    E.2.2Secondary objectives of the trial
    - To further evaluate the efficacy of BMS-986166 and of branebrutinib, each versus placebo at Week 16 in
    patients with moderate-to-severe Atopic Dermatitis.
    - To assess the safety and tolerability of BMS-986166 and of branebrutinib in patients with moderate-to-severe
    Atopic Dermatitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Females or males 18 (or local age of majority)-65 years inclusive
    •Dx of AD of at least 24 months duration
    •Screening EASI ≥ 12 and ≥ 16 at baseline
    •vIGA ≥ 3 at screening and baseline
    •documented history of inadequate control of AD by a stable regimen (≥ 4 weeks) of topical corticosteroids, calcineurin inhibitors or biologics, within 6 months of randomization or inappropriateness of tx dur to side effects or safety risks.
    •Documentation of positive VZV Ig antibody status or complete VZV vaccination within 90 days of first dosing.
    E.4Principal exclusion criteria
    •Any major illness, condition, infection, cancer or hx of cancer or lymphoproliferative disease, including prelymphoma
    •Pregnancy, lactation, or plans for either
    •Clinically relevant cardiovascular or pulmonary conditions (including severe sleep apnea)
    •History of significant ocular disease
    •History of diabetes mellitus Type 1 or uncontrolled diabetes mellitus Type 2 with hemoglobin ALC > 8% or diabetic patients with significant comorbidities like retinopathy or nephropathy
    • History of testicular disease or epididymal disease/disorder except uncomplicated epididymitis successfully treated with antibiotics
    •Serum creatinine and total bilirubin > 2mg/dL
    •eGFR < 60mL/min/1.73 m2
    •ALT/AST > 1.5x ULN
    •Hemoglobin < 10 g/dL
    •Abnormal OCT test suggestive of macular or choroidal pathology

    •Surgery within the past 30 days before first dose or planned surgery during the study
    •History of TB
    •Positive result for Hepatitis B, Hepatitis C, HIV infection
    •History of congenital or acquired immunodeficiency
    •Presence of COVID-19 symptoms, COVID (suspected or confirmed) within 12 weeks of screening, at screening, or on Day 1, known or suspected sequelae of any sort following a prior episode of COVID, COVID vaccination within 14 days of screening (or plans to receive COVID vaccine during the study)
    •High likelihood (based on subject history) of requiring rescue therapy in < 4 weeks of randomization
    •Evidence of acute AD flare between screening and baseline/randomization
    •Treatment with anticoagulant or antiplatelet therapies (including aspirin for cardioprotection within 2 weeks prior to randomization
    •AD-related prescription or OTC skin barrier treatments within 2 weeks of randomization
    •Use of strong or moderate inhibitors or inducers of CYP2C8 or 3A4 within 5 half-lives or 14 days prior to randomization (inhibitors) or within 3 weeks prior to randomization (inducers)
    •Use of systemic immunosuppressive drugs or oral herbal immunomodulatory medications within 8 weeks of randomization
    •IV immunoglobulin within 8 weeks of randomization or during the study
    •Use of biologics within 8 weeks to 6 months (depending on type) prior to randomization
    •Prior exposure to BTK inhibitors or S1PR modulators
    •Use of any immunomodulator or investigational drug within the longer of 5 PK half-lives or 5 PD half-lives or within 6 months prior to randomization
    •WBC < 3000/µL or > 14,000/µL
    •ANC < the lower of either LLN or 1500/µL
    •ALC < 1000/µL
    •Platelet count < 100,000/µL
    E.5 End points
    E.5.1Primary end point(s)
    1. Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 16
    E.5.2Secondary end point(s)
    2. Proportion of participants exhibiting a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (cleared) or 1 (almost cleared) AND a ≥ 2 point reduction from baseline
    3. Proportions of participants exhibiting a ≥ 50% (EASI-50) reduction from baseline in EASI score
    4. Proportion of participants exhibiting a ≥ 4-point improvement from baseline in Pruritus NRS at Week
    16.
    5. Mean percentage change from baseline in Pruritus Numerical Rating Scale (NRS) score
    6. Mean change from baseline in percentage of affected Body Surface Area (BSA)
    7. Incidence and severity of all AE, and SAE
    8. Incidence and severity of clinically significant changes in vital signs, ECG, OCT, PFT, and/or safety
    laboratory tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    2-8: At 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 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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 trial5
    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 EEA21
    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
    Australia
    Canada
    United States
    Austria
    Germany
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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
    End of study is defined as the last contact with the last participant (either last visit at which the last endpoint data is collected or last contact which could be a phone call).
    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 days10
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 240
    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 study, BMS will not continue to provide BMS supplied study treatment to participants/investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.
    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 Decision2021-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-22
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