Clinical trial • Phase III • Immunology|Dermatology
DUPILUMAB for Lichen simplex chronicus|Neurodermatitis
Phase III trial of DUPILUMAB for Lichen simplex chronicus|Neurodermatitis.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Lichen simplex chronicus|Neurodermatitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 30-09-2024
- First CTIS Authorization Date
- 04-02-2025
Trial design
Randomised, matched placebo for test product (matched placebo); dose/schedule not specified in ctis record-controlled Phase III trial in Belgium, Czechia, Germany and others.
- Randomised
- Yes
- Comparator
- Matched placebo for test product (matched placebo); dose/schedule not specified in CTIS record
- Target Sample Size
- 119
- Trial Duration For Participant
- 168
Eligibility
Recruits 119 Vulnerable population selected in the CTIS record. Participants must be adults ("Participant must be at least 18 years of age or the legal age of consent...") and provide informed consent. Subject information and informed consent forms (L1-sis-icf-main) are provided in multiple languages (see documents); no assent process is mentioned..
- Vulnerable Population
- Vulnerable population selected in the CTIS record. Participants must be adults ("Participant must be at least 18 years of age or the legal age of consent...") and provide informed consent. Subject information and informed consent forms (L1-sis-icf-main) are provided in multiple languages (see documents); no assent process is mentioned.
Inclusion criteria
- {"criterion_text":"- Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.\n- Participants with moderate-to-severe LSC, as defined by Investigator’s Global Assessment (IGA) score ≥3 and one or more of the following: at least 1 single anogenital lesion; at least 2 lesions including 1 lesion of ≥3 cm in diameter; at least 1 severe lesion (IGA score = 4).\n- History of LSC for at least 6 months prior to the screening visit.\n- On the Worst-Itch Numerical Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst-itch of LSC score of ≥7 in the 7 days prior to Day 1. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization can be postponed until this requirement is met, but without exceeding the 28-day maximum duration of the screening period\n- History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable. Patients with documented systemic treatment for LSC (other than antihistamines) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with dupilumab after appropriate washout.\n- Appropriate contraceptive measures"}
Exclusion criteria
- {"criterion_text":"- Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus\n- Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, lichen planus hypertrophicus.\n- Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study.\n- Severe psychiatric disease that, in the Investigator’s judgement, would affect the study intervention evaluation.\n- Having received or planning to use any of the treatments within the timeframe as specified in the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24","definition_or_measurement_approach":"Measured by Worst-Itch Numerical Rating Scale (WI-NRS) weekly average of daily scores; responder defined as reduction ≥4 from baseline to Week 24."}
Secondary endpoints
- {"endpoint_text":"- Absolute change in weekly average of daily WI-NRS from baseline to Week 24","definition_or_measurement_approach":"Change in weekly average of daily WI-NRS from baseline to Week 24."}
- {"endpoint_text":"- Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24","definition_or_measurement_approach":"Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24."}
- {"endpoint_text":"- Absolute change in ItchyQoL score from baseline to Week 24","definition_or_measurement_approach":"Change in ItchyQoL questionnaire total score from baseline to Week 24."}
- {"endpoint_text":"- Absolute change in DLQI total score from baseline to Week 24","definition_or_measurement_approach":"Change in Dermatology Life Quality Index (DLQI) total score from baseline to Week 24."}
- {"endpoint_text":"- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12","definition_or_measurement_approach":"Responder proportion using weekly average of daily WI-NRS with ≥4 reduction from baseline to Week 12."}
- {"endpoint_text":"- Incidence of treatment-emergent ADA against dupilumab","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies (ADA) against dupilumab."}
- {"endpoint_text":"- Percentage of participants experiencing TEAEs or SAEs from baseline through Week 24","definition_or_measurement_approach":"Proportion of participants reporting treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through Week 24."}
- {"endpoint_text":"- Percentage change in weekly average of daily WI-NRS from baseline to Week 24","definition_or_measurement_approach":"Percent change in weekly average of daily WI-NRS from baseline to Week 24."}
- {"endpoint_text":"- Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24","definition_or_measurement_approach":"Percent change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24."}
- {"endpoint_text":"- Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24","definition_or_measurement_approach":"Proportion of participants achieving Investigator's Global Assessment (IGA) score 0 or 1 for LSC at Week 12 and Week 24."}
- {"endpoint_text":"- Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24","definition_or_measurement_approach":"Composite responder: both WI-NRS weekly average reduction ≥4 from baseline to Week 24 and IGA score 0 or 1 at Week 24."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Magdeburger Company For Medical Studies & Services GmbH (patient organisation/association) is listed among third parties
- Digital Remote Recruitment
- True - digital methods/materials include study website pages and online/print media materials (documents: website-emovis-berlin, online-and-print-media), with materials prepared in multiple country languages
- Planned Sample Size
- 119
- Recruitment Window Months
- 29
- Consent Approach
- Informed consent required from each participant (participants must be at least 18 years old or the legal age of consent). Subject information and informed consent forms (L1-sis-icf-main and language variants) are provided in multiple languages (English, Dutch, French, Czech, German, Greek, Hungarian, Portuguese, Italian, Spanish and others as listed in CTIS documents). No participant assent process is mentioned.
Methods
- Doctor-to-doctor (dr-to-dr) letters (country-specific versions listed in documents)
- Patient letters ("patient-letter" documents in multiple languages)
- Posters (K2 recruitment material posters in multiple languages)
- Flyers (K2 recruitment material flyers in multiple languages)
- Website recruitment / online materials (website and online-and-print-media documents, e.g. Emovis Berlin website material)
- Online and print media (channel specified in K2 online-and-print-media materials)
- K1 recruitment arrangements documents (general recruitment arrangement templates provided)
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 77
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-01-2025
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Associatie dermatologie Maldegem
- Department Name
- Associatie dermatologie Maldegem
- Contact Person Name
- Emma Coussens
- Contact Person Email
- emma.coussens@dermatologiemaldegem.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 07-01-2025
- Latest Decision Or Authorization Date
- 05-02-2025
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- CCR Ostrava s.r.o.
- Contact Person Name
- Sylva Zajicova
- Contact Person Email
- sylva.zajicova@ccrostrava.com
Germany
- Earliest CTIS Part Ii Submission Date
- 25-11-2024
- Latest Decision Or Authorization Date
- 07-02-2025
- Processing Time Days
- 74
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- University Of Luebeck
- Department Name
- Neurologie
- Contact Person Name
- Diamant Thaci
- Contact Person Email
- diamant.thaci@uksh.de
- Site Name
- Emovis GmbH
- Department Name
- Dermatology
- Contact Person Name
- Saskia Kerschischnik
- Contact Person Email
- saskia.kerschischnik@futuremeds.com
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Dermatologie
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Magdeburger Company For Medical Studies & Services GmbH
- Department Name
- Dermatology
- Contact Person Name
- Jens-Joachim Brucher
- Contact Person Email
- Jens-joachim.bruecher@sigal-sms.de
Greece
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 111
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 2nd Department of Dermatology
- Contact Person Name
- Elisavet Lazaridou
- Contact Person Email
- bethlaz@auth.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Dermatology and Venereology
- Contact Person Name
- Alexandros Katoulis
- Contact Person Email
- alexanderkatoulis@yahoo.co.uk
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- A’ Dermatology Department
- Contact Person Name
- Eleni Sotiriou
- Contact Person Email
- elenasotiriou@yahoo.gr
Hungary
- Earliest CTIS Part Ii Submission Date
- 21-11-2024
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 75
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Derm-Surg Kft.
- Department Name
- Bőrgyógyászat és allergológiai rendelő
- Contact Person Name
- Beata Fabos
- Contact Person Email
- fabosbeata@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Bőrgyógyászati Klinika
- Contact Person Name
- Andrea Szegedi
- Contact Person Email
- aszegedi@med.unideb.hu
Portugal
- Earliest CTIS Part Ii Submission Date
- 09-01-2025
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Serviço de Dermatologia
- Contact Person Name
- Tiago Torres
- Contact Person Email
- tiagotorres.dermatologia@chporto.min-saude.pt
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Centro de Dermatologia
- Contact Person Name
- Pedro Bastos
- Contact Person Email
- pmendesbastos@gmail.com
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Serviço de Dermatologia
- Contact Person Name
- Margarida Goncalo
- Contact Person Email
- mgoncalo@fmed.uc.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 12-12-2024
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- U.O.S.D. Dermatologia
- Contact Person Name
- Marco Galluzzo
- Contact Person Email
- marco.galluzzo@uniroma2.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O. Dermatologia
- Contact Person Name
- Alessandro Pileri
- Contact Person Email
- alessandro.pileri2@unibo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 10-02-2025
- Processing Time Days
- 117
- Number Of Sites
- 5
- Number Of Participants
- 19
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servei de Dermatologia
- Contact Person Name
- Maria Florencia Vera
- Contact Person Email
- MVERAM@recerca.clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servei de Dermatologia
- Contact Person Name
- Jordi Mollet
- Contact Person Email
- jordi.mollet@vallhebron.cat
- Site Name
- Hospital Arnau De Vilanova De Valencia
- Department Name
- Servicio de Dermatología
- Contact Person Name
- Javier Miquel
- Contact Person Email
- fjmiquel0406@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Servei de Dermatologia
- Contact Person Name
- Esther Serra-Baldrich
- Contact Person Email
- eserra@santpau.cat
- Site Name
- Hospital Universitario De Torrejon
- Department Name
- Servicio de Dermatología
- Contact Person Name
- Elena Sánchez Largo
- Contact Person Email
- elena.sanchezlargo@gmail.com
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Parexel International Services India Private Limited
- Responsibilities
- Sponsor duty code 8
- Name
- PPD International Holdings LLC
- Responsibilities
- Sample management (testing/storage)
- Name
- Endpoint Clinical Inc.
- Responsibilities
- Sponsor duty code 3
Third parties
- {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"Sponsor duty code 14","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Clinical Outcomes Assessment Instrument (eCOA) (sponsor duty code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Sponsor duty code 3","organisation_type":"Pharmaceutical company"}
- {"country":"Hungary","full_name":"European Pharma Hub Kft.","duties_or_roles":"Sponsor duty code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"Sponsor duty code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Sponsor duty code 14","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Marken","duties_or_roles":"Sponsor duty code 14","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"Sponsor duty code 8","organisation_type":"Pharmaceutical company"}
- {"country":"Portugal","full_name":"Evidenze Portugal Unipessoal Lda.","duties_or_roles":"Sponsor duty code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Sample management (testing/storage) (sponsor duty code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsor duty code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample long term storage (sponsor duty code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"Sponsor duty code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Dupilumab
- Active Substance
- DUPILUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- EU product record present (euMpNumber PRD10065701, prodAuthStatus 1)
- Maximum Dose
- max daily dose amount 300 mg; max total dose amount 3900 mg; maxTreatmentPeriod 24 (timeUnitCode 2)
- Investigational Product Name
- Matched placebo for test product
- Modality
- Other
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