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    Summary
    EudraCT Number:2020-000727-40
    Sponsor's Protocol Code Number:230LE301
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2020-000727-40
    A.3Full title of the trial
    A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)
    Randomizované, dvojito zaslepené, placebom kontrolované, multicentrické, súvislé skúšanie pozostávajúce z 2 častí – časti A (2. fáza) a časti B (3. fáza) – na vyhodnotenie účinnosti a bezpečnosti BIIB059 u účastníkov s aktívnym subakútnym alebo chronickým kutánnym lupusom erythematosus so systémovými prejavmi alebo bez nich, pričom účastníci sú refraktérni na liečbu antimalarikami alebo ju netolerujú (AMETHYST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
    Skúšanie na vyhodnotenie účinnosti a bezpečnosti BIIB059 u účastníkov s aktívnym subakútnym alebo chronickým kutánnym lupusom erythematosus so systémovými prejavmi alebo bez nich, pričom účastníci sú refraktérni na liečbu antimalarikami alebo ju netolerujú.
    A.3.2Name or abbreviated title of the trial where available
    AMETHYST
    A.4.1Sponsor's protocol code number230LE301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05531565
    A.5.4Other Identifiers
    Name:INDNumber:135703
    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 SponsorBiogen Idec Research 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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact pointN/A
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailclinicaltrials@biogen.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 namelitifilimab
    D.3.2Product code BIIB059
    D.3.4Pharmaceutical form 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 INNlitifilimab
    D.3.9.1CAS number 2407378-48-5
    D.3.9.2Current sponsor codeBIIB059
    D.3.9.3Other descriptive nameHumanised IgG1 monoclonal antibody against blood dendritic cell antigen 2
    D.3.9.4EV Substance CodeSUB208560
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant monoclonal antibody
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subacute Cutaneous Lupus Erythematosus
    Chronic Cutaneous Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Lupus
    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 PT
    E.1.2Classification code 10056509
    E.1.2Term Cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057903
    E.1.2Term Subacute cutaneous lupus erythematosus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057929
    E.1.2Term Chronic cutaneous lupus erythematosus
    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
    The primary objectives of the study are to evaluate the efficacy of BIIB059 compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    1. Histologically confirmed (in the past during the Screening period) diagnosis of CLE with or without systemic manifestations.
    2. Must have active cutaneous manifestations that meet study criteria.
    3. Must have a CLASI-A score ≥10.
    4. Must have an active CLE lesion despite an adequate trial of antimalarial treatment.

    NOTE: Other protocol defined Exclusion criteria may apply.
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    1. Any active skin conditions other than CLE that may interfere with the study assessments of CLE.
    2. Active severe lupus nephritis.
    3. Active neuropsychiatric SLE.
    4. Use of intralesional corticosteroids within 1 week prior to Screening and during the study
    5. Use of immunosuppressive or disease-modifying treatments for SLE or CLE [via an oral, intravenous (IV), or SC route] that were initiated less than 12 weeks prior to randomization, have not been at a stable and allowable dose.

    NOTE: Other protocol defined Exclusion criteria may apply.

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    *Parts A (US+ROW) and B (US): Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician’s Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1
    * Part B (ROW): Percentage of Participants who Achieve Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-70) Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Parts A (US+ROW) and B (US): Week 16
    Part B (ROW): Baseline to Week 24
    E.5.2Secondary end point(s)
    *Parts A(US+ROW)&B(US): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
    *Part B(ROW): % of Participants who Achieve CLASI-70 Response, Defined as ≥ 70% Decrease in CLASI-A Score From Baseline
    *Part A(US+ROW): % of Participants who Achieve a CLASI-50 Response, Defined as a ≥ 50% Decrease in CLASI-A Score From Baseline
    *Part A(US+ROW): Change From Baseline in CLASI-D Score
    *Part B (US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1, at W16&W24, Respectively, for Participants in Full Analysis Set (FAS), who had CLA-IGA-R Erythema Score ≥3 and OMC Score ≥3 at Baseline
    *Part B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1, at W16&W24, Respectively, for Participants in FAS, who had CLA-IGA-R Erythema Score≥3 and OMC Score≥3 at Baseline
    *Part B(US+ROW): % of Participants who Achieve at Least 1 Level of Improvement From Baseline in the CLA-IGA-R Erythema Score
    *Part B(US+ROW): Absolute Change in CLASI-D Score
    *Part B(US+ROW): Percent Change in CLASI-D Score
    *Part B(US+ROW): Change From Baseline in CLE-QoL Score
    *Part B(US+ROW): Change From Baseline in DLQI Score
    *Parts A(US+ROW)&B(US): % of Participants who Achieve a CLASI-70 Response, Defined as a≥ 70% Decrease in CLASI-A Score From Baseline
    *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Erythema Score of 0 or 1
    *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline
    *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R OMC Score of 0
    *Parts A&B(US+ROW): % of Participants With at Least 1 Level of Improvement From Baseline in CLA-IGA-R OMC Score
    *Parts A&B(US+ROW): % of Participants who Achieve a CLA-IGA-R Follicular Activity Score of 0
    *Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1
    *Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 or 1
    *Parts A&B(US+ROW): % of Participants who Achieve a CLASI-A Score of 0 to 3
    *Parts A&B(US+ROW): % of Participants who Achieve a 70% Reduction in CLASI-A
    *Parts A&B(US+ROW): % of Participants who Achieve a 50% Reduction in CLASI-A
    *Parts A&B(US+ROW): % of Participants who Achieve a 7-Point Reduction From Baseline in CLASI-A Score
    *Parts A&B(US+ROW): % of Participants With a CLASI-70 Response at W52 Among CLASI-70 Responders at W16&W24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
    *Parts A&B(US+ROW): % of Participants With CLA-IGA-R Erythema Score of 0 or 1 at W52 Among CLA-IGA-R Erythema Responders at W16&W24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
    *Parts A&B(US+ROW): % of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at W52 Among CLA-IGA-R OMC Responders at W16&24, Respectively, who Were Assigned to Receive BIIB059 in DBPC TP
    *Parts A&B(US+ROW): % of Participants With CLA-IGA-R OMC Score of 0 at W52 Among Responders With CLA-IGA-R OMC Score of 0 at W16&W24, Respectively, who Were Randomly Assigned to Receive BIIB059 During the DBPC TP
    *Parts A&B(US+ROW): % of Participants With CLA-IGA-R Follicular Activity Score of 0 at W52 Among CLA-IGA-R Follicular Activity Responders at W16&W24, Respectively, who Were Randomly Assigned to Receive BIIB059 in DBPC TP
    *Parts A&B(US+ROW): % of Participants With a CLASI-70 Response at W52 Among CLASI-70 Nonresponders at W16&W24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
    *Parts A&B(US+ROW): % of Participants With a CLA-IGA-R Erythema Score of 0 or 1 at W52 Among CLA-IGA-R Erythema Nonresponders at W16&W24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
    *Parts A,B(US+ROW): % of Participants With CLA-IGA-R OMC Score of 0/1 and at Least 1 Level of Improvement From Baseline at W52 Among CLA-IGA-R OMC Nonresponders at Wks16&24, Respectively, who Were Assigned to Receive Placebo in DBPC TP
    *Parts A&B(US+ROW): % of Participants With a CLA-IGA-R OMC Score of 0 at W52 Among CLA-IGA-R OMC Nonresponders at W16&W24, Respectively, who Were Randomly Assigned to Receive Placebo During the DBPC TP
    *Parts A&B(US+ROW): % of Participants who Achieve CLA-IGA-R Follicular Activity Score of 0 at W52 Among CLA-IGA-R Follicular Activity Nonresponders at Wks16&24, Respectively, who Were Randomly Assigned to Receive Placebo in DBPC TP
    *Parts A&B(US+ROW): Annualized Mild and Moderate Safety of Estrogens in LE National Assessment-SLE Disease Activity Index Flare Index (SFI) Rate and Annualized Severe SFI Rate Through W24
    *Parts A&B(US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through W16
    *Parts A&B(US+ROW): Annualized Mild and Moderate SFI Rate and Annualized Severe SFI Rate Through W52
    *Parts A&B(US+ROW): Number of Participants Experiencing TEAEs and SAEs
    *Parts A&B(US+ROW): Number of Participants With Anti-BIIB059 Antibodies in Serum During the Study
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Week 16, Week 16, Up to Week 24, Week 24, Up to Week 52, Week 52, Baseline up to Week 52, Up to Week 76
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and tolerability
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    A 2-part seamless design study
    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 trial4
    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 EEA83
    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
    Argentina
    Chile
    Colombia
    Peru
    Philippines
    Switzerland
    Puerto Rico
    Taiwan
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Mexico
    Saudi Arabia
    Serbia
    United Kingdom
    United States
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    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
    The end of the study period (i.e., DBPC followed by ETP) is Week 52/EOS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days29
    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: 464
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 474
    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)
    Participants who successfully stay in treatment up to Week 52 visit will be offered the opportunity to enroll in an open-label LTE study, which will be described in a separate protocol.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DrugDev
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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