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    Summary
    EudraCT Number:2020-004703-14
    Sponsor's Protocol Code Number:ACT16404
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004703-14
    A.3Full title of the trial
    A randomized, double-blind, placebo controlled, proof of concept study assessing the efficacy and safety of the RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of concept study of SAR443122 in patients with cutaneous lupus erythematosus
    A.3.2Name or abbreviated title of the trial where available
    CLEan
    A.4.1Sponsor's protocol code numberACT16404
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1246-6784
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Sp. z o.o.
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street Addressul. Bonifraterska 17
    B.5.3.2Town/ cityWarszawa
    B.5.3.3Post code00-203
    B.5.3.4CountryPoland
    B.5.4Telephone number+482228 00 000
    B.5.6E-mailinformacja.medyczna@sanofi.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 nameSAR443122
    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 INN eclitasertib
    D.3.9.1CAS number 2125450-76-0
    D.3.9.2Current sponsor codeSAR443122
    D.3.9.3Other descriptive nameSAR443122
    D.3.9.4EV Substance CodeSUB198211
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Cutaneous Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    Cutaneous Lupus Erythematosus
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Assess the efficacy of SAR443122 in cutaneous lupus erythematosus (CLE)
    E.2.2Secondary objectives of the trial
    • Assess the effect of SAR443122 on the physician’s global assessment of disease activity (PhysGA – disease activity)

    • Assess the effect of SAR443122 on CLE induced itch and overall pain

    • Assess the effect of SAR443122 on the proportion of disease activity responders compared to placebo

    • Assess the effect of SAR443122 on the CLASI components score

    • Assess the effect of SAR443122 on the Investigator’s global assessment for CLE (IGA-CLE)

    • Assess oral cavities for patients with oral lesions

    • Assess the disease specific quality of life (QoL)

    • Assess the safety and tolerability of SAR443122 in patients with CLE

    • Assess the pharmacokinetics (PK) exposure of SAR443122 in patients with CLE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participants with cutaneous lupus erythematosus either in the form of discoid/chronic cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus for at least 3 months before Screening.
    - Participants with histologically confirmed and documented diagnosis within one year prior to Screening or during Screening period prior to randomization.
    - Active cutaneous lupus erythematosus skin lesions and a Cutaneous Erythematosus.
    - Disease Area and Severity Index activity (CLASI-A) ≥10 both at Screening and Baseline.
    - Participant who is candidate for systemic treatment per Investigator’s judgement.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - Systemic lupus erythematosus according to the 2012 SLICC criteria with major organ involvement.
    - Suspected or proven drug induced lupus erythematosus, including patients with positive antihistone autoantibody tests.
    - Autoimmune disease(s) other than systemic lupus erythematosus.
    - Active skin diseases that may interfere with the study or study assessments.
    - Exclusion related to tuberculosis, non-tuberculous mycobacterial infections, HIV, HBV, HCV, Herpes zoster, COVID-19 and other recurrent or recent serious infections.
    - Prolonged QTcF ≥ 450 ms (by Fredericia formula) or clinically significant findings on electrocardiogram (ECG).
    - Cannot avoid excessive UV exposure 4 weeks prior to baseline and during the study. Routine sun exposure through work are permitted but requires the use of sun block to sun exposed areas for at least 4 weeks prior to baseline and during the study.
    - Concomitant treatment with topical immunosuppressants beyond a stable regimen of low to medium potency topical corticosteroids and/or topical calcineurin inhibitors during the study and two weeks before baseline visit.
    - Initiation and/or changes in dosage of chloroquine/hydroxychloroquine within 12 weeks prior to Screening visit (or during Screening period) and/or the dose exceeding 2.3 mg/kg/day for chloroquine or 400 mg/day for hydroxychloroquine.
    - Systemic treatments for cutaneous or systemic lupus erythematosus or immunosuppressive therapy for autoimmune disease other than the study medication. Systemic corticosteroids treatment <4 weeks before baseline visit.
    - Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study.
    - Laboratory abnormalities at the Screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in Cutaneous Erythematosus Disease Area and Severity Index activity (CLASI-A) sub-score: The Cutaneous Erythematosus Disease Area and Severity Index (CLASI) is a clinician rated scale composed of 56 items designed to assess the disease activity and damage in CLE in adults. The disease activity (CLASI-A) sub-score ranges from 0 to 70: 0–9 indicating mild disease, 10–20 indicating moderate disease, and 21–70 indicating severe disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Week 12
    E.5.2Secondary end point(s)
    1-Proportion of patients with physician’s global assessment of disease activity (PhysGA – disease activity) of 0 or 1 (disease free or almost disease free): The PhysGA-disease activity is a 5 point-Lickert scale instrument designed to assess physician-reported disease activity ranging from “Not active at all” to “Extremely active”.

    2-Change from baseline in patients reported daily worst itch using Peak Pruritus Numerical Rating Scale (itch-NRS): The itch-NRS is a single item patient-reported outcome (PRO) tool that patients will use to report the intensity of their pruritus (itch) during a daily recall period. Patients will be asked to rate their worst itch on a 0 (“No itch”) to 10 (“Worst itch imaginable”) NRS.

    3-Change from baseline in patients reported daily worst pain using Peak Pain Numerical Rating Scale (Pain-NRS): The Pain-NRS is a single item PRO tool that patients will use to report the intensity of their CLE-related pain (skin, oral, genital) during a daily recall period. Patients will be asked to rate their worst pain on a 0 (“No pain”) to 10 (“Worst pain imaginable”) NRS.

    4-Proportion of CLASI-A50 and CLASI-A75 responders: The CLASI-A50/75 response is defined as a patient achieved a decrease by at least 50%/75% of CLASI-A sub-score from baseline.

    5-Change from baseline in CLASI components’ score: Change from baseline in CLASI components’ score over time

    6-Proportion of patients with the Investigator’s global assessment for CLE (IGA-CLE) score of 0 or 1 (clear or almost clear): The IGA-CLE is a clinician reported outcome that allows for clinicians to assess the overall disease activity of CLE using a 5-point scale from 0 (clear) to 4 (severe).

    7-Change from baseline in the Oral Health Impact Profile (OHIP-14) for patients with oral lesions at baseline: OHIP-14 is a PRO questionnaire measures people’s perception of dysfunction, discomfort and disability attributed to oral conditions in adults. It is composed of 14 items that assess seven different dimensions. The OHIP-14 scores can range from 0 to 56 and higher OHIP-14 scores indicate worse oral-health-related quality of life.

    8-Change from baseline in SKINDEX-29+3 total score: Skindex-29 is a PRO measure designed to assess the effects of skin disease on patients' health-related quality of life in adults. It contains 29 items, distributed across 3 domains. Individual items are scored from 0 to100 in 25-point increments with 100 representing maximal disability. The Skindex 29+3 includes a fourth subscale (3 questions) to assess lupus-specific issues.

    9-Total number of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

    10-Percent of TEAEs, SAEs and AESIs

    11-Percent of potentially clinically significant abnormalities (PCSAs): Percent of potentially clinically significant abnormalities (PCSAs) in laboratory tests, electrocardiogram (ECG) or vital signs through end of study

    12-SAR443122 plasma concentration

    13-Assessment of pharmacokinetic (PK) parameter: Cmax: Maximum plasma concentration

    14-Assessment of PK parameter: tmax: Time to reach Cmax

    15-Assessment of PK parameter: AUC0-tau: Area under the plasma concentration - time curve over the dosing interval

    16-Assessment of PK parameter: t1/2z : Elimination half-life
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 4, 6: Week 12

    2, 3, 7, 8: Baseline to Week 12

    5: Baseline up to Week 12

    9, 10, 11: Screening up to end of study (Week 16)

    12 to 16: Day 1, Day 57 and Day 85
    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 Yes
    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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Australia
    Chile
    India
    Mexico
    United States
    Poland
    Spain
    Czechia
    Italy
    Hungary
    Russian Federation
    Ukraine
    United Kingdom
    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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 135
    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 Decision2021-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-26
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