Clinical trial • Phase III • Dermatology

AMLITELIMAB for Atopic dermatitis

Phase III trial of AMLITELIMAB for Atopic dermatitis.

Overview

Trial Therapeutic Area: Dermatology
Trial Disease: Atopic dermatitis
Trial Stage: Phase III
Drug Modality: Monoclonal antibody
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 07-02-2024
First CTIS Authorization Date: 29-05-2024

Trial design

Randomised, placebo (matched, administered by subcutaneous injection). dose/schedule not specified in the available ctis documents.-controlled Phase III trial in Italy, Greece, Spain and others.

Randomised: Yes
Comparator: Placebo (matched, administered by subcutaneous injection). Dose/schedule not specified in the available CTIS documents.
Target Sample Size: 432
Trial Duration For Participant: 252

Eligibility

Recruits 432 paediatric patients.

Vulnerable Population: The trial includes adolescents (participants aged 12 years and older). Informed consent/assent materials for adolescents and parents/guardians are included in the submitted documents (e.g. redacted sis-icf adolescent, redacted sis-icf parent, assent and parent forms across languages), indicating that assent and parental/guardian consent procedures are planned for minors.

Inclusion criteria

{"criterion_text":"- Participants must be 12 years of age (when signing informed consent form)\n- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)\n- Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.\n- v-IGA-AD of 3 or 4 at baseline visit\n- EASI score of 16 or higher at baseline\n- AD involvement of 10% or more of BSA at baseline\n- Weekly average of daily PP-NRS of ≥ 4 at baseline visit.\n- Able and willing to comply with requested study visits and procedures\n- Body weight ≥25 kg"}

Exclusion criteria

{"criterion_text":"- Skin co-morbidity that would adversely affect the ability to undertake AD assessments\n- History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)\n- Known history of or suspected significant current immunosuppression\n- Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)\n- History of solid organ or stem cell transplant\n- Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline\n- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit\n- Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB\n- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit\n- In the Investigator’s opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening"}

Endpoints

Primary endpoints

{"endpoint_text":"- EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36","definition_or_measurement_approach":"Proportion of participants at Week 36 achieving vIGA-AD = 0 or 1 with ≥2-point reduction from baseline (investigator-assessed vIGA-AD)."}
{"endpoint_text":"- EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI 75) at Week 36","definition_or_measurement_approach":"Proportion of participants at Week 36 achieving ≥75% reduction from baseline in EASI score (EASI-75)."}
{"endpoint_text":"- US and US reference countries: Proportion of participants with vIGA AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36","definition_or_measurement_approach":"Proportion of participants in US/US reference countries at Week 36 achieving vIGA-AD = 0 or 1 with ≥2-point reduction from baseline."}

Secondary endpoints

{"endpoint_text":"- Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only)","definition_or_measurement_approach":"Proportion achieving ≥75% reduction in EASI at Week 36 (US/US reference countries subgroup)."}
{"endpoint_text":"- Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) and a reduction from baseline of ≥2 points","definition_or_measurement_approach":"Proportion with vIGA-AD 0/1 with only barely perceptible erythema and ≥2-point reduction from baseline."}
{"endpoint_text":"- Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4","definition_or_measurement_approach":"Proportion achieving ≥4-point reduction in weekly average daily PP-NRS from baseline among those with baseline PP-NRS weekly average ≥4."}
{"endpoint_text":"- Proportion of participants reaching EASI-75","definition_or_measurement_approach":"Proportion achieving ≥75% reduction in EASI score."}
{"endpoint_text":"- Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points","definition_or_measurement_approach":"Proportion achieving vIGA-AD 0 or 1 with ≥2-point reduction from baseline."}
{"endpoint_text":"- Proportion of participants reaching EASI-90","definition_or_measurement_approach":"Proportion achieving ≥90% reduction in EASI score."}
{"endpoint_text":"- Proportion of participants reaching EASI-100","definition_or_measurement_approach":"Proportion achieving 100% reduction (complete clearance) in EASI score."}
{"endpoint_text":"- Proportion of participants with PP-NRS ≤1","definition_or_measurement_approach":"Proportion of participants with weekly average daily PP-NRS ≤1."}
{"endpoint_text":"- Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old","definition_or_measurement_approach":"Absolute change from baseline in DLQI for participants aged ≥16 years."}
{"endpoint_text":"- Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4","definition_or_measurement_approach":"Proportion with ≥4-point DLQI reduction from baseline among participants aged ≥16 with baseline DLQI ≥4."}
{"endpoint_text":"- Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years","definition_or_measurement_approach":"Absolute change from baseline in CDLQI for participants aged ≥12 to <16 years."}
{"endpoint_text":"- Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6","definition_or_measurement_approach":"Proportion with ≥6-point CDLQI reduction among participants aged ≥12 to <16 with baseline CDLQI ≥6."}
{"endpoint_text":"- Change in Hospital Anxiety Depression Scale (HADS) from baseline","definition_or_measurement_approach":"Absolute change from baseline in HADS total score."}
{"endpoint_text":"- Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8","definition_or_measurement_approach":"Proportion with HADS-A <8 among those with baseline HADS-A ≥8."}
{"endpoint_text":"- Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8","definition_or_measurement_approach":"Proportion with HADS-D <8 among those with baseline HADS-D ≥8."}
{"endpoint_text":"- Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline","definition_or_measurement_approach":"Absolute change from baseline in weekly average daily SP-NRS."}
{"endpoint_text":"- Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4","definition_or_measurement_approach":"Proportion with ≥4-point reduction in weekly average daily SP-NRS among those with baseline weekly average ≥4."}
{"endpoint_text":"- Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline","definition_or_measurement_approach":"Absolute change from baseline in weekly average daily SD-NRS."}
{"endpoint_text":"- Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3","definition_or_measurement_approach":"Proportion with ≥3-point reduction in weekly average daily SD-NRS among those with baseline weekly average ≥3."}
{"endpoint_text":"- Percent change in EASI score from baseline","definition_or_measurement_approach":"Percent change from baseline in EASI score."}
{"endpoint_text":"- Percent change in weekly average of daily PP-NRS from baseline","definition_or_measurement_approach":"Percent change from baseline in weekly average daily PP-NRS."}
{"endpoint_text":"- Absolute change in weekly average of daily PP-NRS from baseline","definition_or_measurement_approach":"Absolute change from baseline in weekly average daily PP-NRS."}
{"endpoint_text":"- Proportion of participants reaching EASI-50","definition_or_measurement_approach":"Proportion achieving ≥50% reduction in EASI."}
{"endpoint_text":"- Proportion of participants with EASI ≤7","definition_or_measurement_approach":"Proportion with absolute EASI score ≤7."}
{"endpoint_text":"- Change in percent Body Surface Area (BSA) affected by AD from baseline","definition_or_measurement_approach":"Percent change from baseline in BSA affected by AD."}
{"endpoint_text":"- Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline","definition_or_measurement_approach":"Percent change from baseline in SCORAD index."}
{"endpoint_text":"- Absolute change in Scoring Atopic Dermatitis (SCORAD) index from baseline","definition_or_measurement_approach":"Absolute change from baseline in SCORAD index."}
{"endpoint_text":"- Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7","definition_or_measurement_approach":"Proportion with ≥8.7-point reduction in SCORAD among those with baseline SCORAD ≥8.7."}
{"endpoint_text":"- Proportion of participants with a reduction in Patient Oriented Eczema Measure (POEM) ≥4 from baseline in participants with POEM Baseline ≥4","definition_or_measurement_approach":"Proportion with ≥4-point POEM reduction among those with baseline POEM ≥4."}
{"endpoint_text":"- Change in POEM from baseline","definition_or_measurement_approach":"Change from baseline in POEM score."}
{"endpoint_text":"- Proportion of participants with rescue medication use","definition_or_measurement_approach":"Proportion of participants using any rescue medication during the study."}
{"endpoint_text":"- Time to onset of effect on PP-NRS as measured by proportion of participants with an improvement (reduction) in PP-NRS by ≥ 4","definition_or_measurement_approach":"Time-to-event: time to first occurrence of ≥4-point reduction in PP-NRS (weekly average) from baseline."}
{"endpoint_text":"- Percentage of TCS/TCI free days","definition_or_measurement_approach":"Percentage of days without topical corticosteroid/topical calcineurin inhibitor use."}
{"endpoint_text":"- Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)","definition_or_measurement_approach":"Incidence and percentage of participants experiencing TEAEs, TESAEs and AESIs (safety outcomes)."}
{"endpoint_text":"- Serum amlitelimab concentrations","definition_or_measurement_approach":"Pharmacokinetic measurement: serum concentrations of amlitelimab at scheduled timepoints."}
{"endpoint_text":"- Incidence of antidrug antibodies (ADAs) of amlitelimab","definition_or_measurement_approach":"Incidence of treatment-emergent anti-drug antibodies to amlitelimab."}
{"endpoint_text":"- Time to onset of effect on vIGA-AD as measured by proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and a reduction from baseline ≥2 during the 36-week treatment period","definition_or_measurement_approach":"Time-to-event: time to first achievement of vIGA-AD 0/1 with ≥2-point reduction during 36-week treatment."}
{"endpoint_text":"- Time to onset of effect on EASI as measured by proportion of participants reaching a 75% reduction from baseline in EASI score during the 36-week treatment period","definition_or_measurement_approach":"Time-to-event: time to first achievement of EASI-75 during 36-week treatment."}
{"endpoint_text":"- Percent change in weekly average of daily SP-NRS from baseline","definition_or_measurement_approach":"Percent change from baseline in weekly average daily SP-NRS."}
{"endpoint_text":"- Proportion of participants with vIGA-AD 0 (clear)","definition_or_measurement_approach":"Proportion of participants achieving vIGA-AD = 0."}
{"endpoint_text":"- Percent change in weekly average of daily SD-NRS","definition_or_measurement_approach":"Percent change from baseline in weekly average daily SD-NRS."}

Recruitment

Digital Remote Recruitment: Yes
Planned Sample Size: 432
Recruitment Window Months: 27
Consent Approach: Informed consent materials are age-specific and country/language-specific. Participants aged 12 years and older sign informed consent; adolescent-specific information/assent forms and parental/guardian consent forms are provided (multiple redacted sis-icf adolescent, parent and assent documents are included for different member states and languages). Documents indicate availability of subject information and consent forms in multiple languages corresponding to participating countries.

Methods

Digital marketing (country-specific documents present, e.g. K2-recruitment-material-digital-marketing-es, K2-recruitment-material-digital-marketing-it) — online ads and digital channels targeted to potential participants in countries with posted materials.
Landing page / online self-assessment (country-specific landing pages documented, e.g. K2-recruitment-material-landing-page-it, K2-recruitment-material-landing-page-es) — web-based recruitment funnel.
Printed materials for patients: flyers, brochures and posters (country-specific K2 recruitment brochure/flyer/poster documents exist for multiple countries: -nl, -de, -pl, -es, -it, -fr, -el).
Healthcare professional outreach: Dr-to-Dr letters (country-specific K2-recruitment-material-dr-to-dr-letter documents) to inform clinicians and facilitate referrals.
Patient-facing multimedia: video storyboard and placebo fact-video scripts (documents e.g. K2-recruitment-material-understanting-ad-video-storyboard-it, placebo fact video scripts) used to inform potential participants.
Trust-builder and placebo fact sheets to address concerns about placebo and build trust (country-specific trust-builder and placebo fact-sheet documents).
Self-assessment tools and secondary assessment/communication materials (documents labelled self-assessment and secondary-assessment-and-communication in country-specific sets).

Geography

Total Number Of Sites: 36
Total Number Of Participants: 90

Italy

Earliest CTIS Part Ii Submission Date: 17-05-2024
Latest Decision Or Authorization Date: 25-02-2026
Processing Time Days: 649
Number Of Sites: 5
Number Of Participants: 20

Sites

Site Name: Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name: UOSD Clinica Dermatologica
Principal Investigator Name: Anna Balato
Principal Investigator Email: anna.balato@unicampania.it
Contact Person Name: Anna Balato
Contact Person Email: anna.balato@unicampania.it

Site Name: Universita' Degli Studi G. D'annunzio Di Chieti
Department Name: CAST - Center for Advanced Studies and Technology
Principal Investigator Name: Paolo Amerio
Principal Investigator Email: p.amerio@unich.it
Contact Person Name: Paolo Amerio
Contact Person Email: p.amerio@unich.it

Site Name: Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name: Dermatologia
Principal Investigator Name: Michela Ortoncelli
Principal Investigator Email: mortoncelli@cittadellasalute.to.it
Contact Person Name: Michela Ortoncelli
Contact Person Email: mortoncelli@cittadellasalute.to.it

Site Name: Hospital Santa Maria Della Misericordia
Department Name: Clinica Dermatologica
Principal Investigator Name: Luca Stingeni
Principal Investigator Email: luca.stingeni@unipg.it
Contact Person Name: Luca Stingeni
Contact Person Email: luca.stingeni@unipg.it

Site Name: Azienda Ospedaliero Universitaria Di Modena
Department Name: Dermatologia
Principal Investigator Name: Caterina Longo
Principal Investigator Email: caterina.longo@unimore.it
Contact Person Name: Caterina Longo
Contact Person Email: caterina.longo@unimore.it

Greece

Earliest CTIS Part Ii Submission Date: 28-05-2024
Latest Decision Or Authorization Date: 24-02-2026
Processing Time Days: 637
Number Of Sites: 4
Number Of Participants: 5

Sites

Site Name: Ippokratio General Hospital Of Thessaloniki
Department Name: 1st Department of Dermatology and Venereology
Principal Investigator Name: Eleni Sotiriou
Principal Investigator Email: elenasotiriou@yahoo.gr
Contact Person Name: Eleni Sotiriou
Contact Person Email: elenasotiriou@yahoo.gr

Site Name: Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name: Department of Dermatology- Venereology
Principal Investigator Name: Alexandros Stratigos
Principal Investigator Email: alstrat2@gmail.com
Contact Person Name: Alexandros Stratigos
Contact Person Email: alstrat2@gmail.com

Site Name: Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Department Name: Dermatology and Venereology Department of N.H.S.
Principal Investigator Name: Vasiliki Chasapi
Principal Investigator Email: chasapiresearch@gmail.com
Contact Person Name: Vasiliki Chasapi
Contact Person Email: chasapiresearch@gmail.com

Site Name: University General Hospital Attikon
Department Name: 2nd Department of Dermatology and Venereology
Principal Investigator Name: Alexander Katoulis
Principal Investigator Email: alexanderkatoulis@yahoo.co.uk
Contact Person Name: Alexander Katoulis
Contact Person Email: alexanderkatoulis@yahoo.co.uk

Spain

Earliest CTIS Part Ii Submission Date: 17-05-2024
Latest Decision Or Authorization Date: 20-02-2026
Processing Time Days: 644
Number Of Sites: 6
Number Of Participants: 12

Sites

Site Name: University Hospital Virgen Del Rocio S.L.
Department Name: Dermatology Department
Principal Investigator Name: Jose Juan Pereyra
Principal Investigator Email: pe3reyra@gmail.com
Contact Person Name: Jose Juan Pereyra
Contact Person Email: pe3reyra@gmail.com

Site Name: Hospital Universitario Quironsalud Madrid
Department Name: Dermatology
Principal Investigator Name: Javier Pedraz Munoz
Principal Investigator Email: javierpedraz78@gmail.com
Contact Person Name: Javier Pedraz Munoz
Contact Person Email: javierpedraz78@gmail.com

Site Name: Hospital Germans Trias I Pujol
Department Name: Dermatology
Principal Investigator Name: Jose Manuel Carrascosa Carrillo
Principal Investigator Email: jmcarrascosac@hotmail.com
Contact Person Name: Jose Manuel Carrascosa Carrillo
Contact Person Email: jmcarrascosac@hotmail.com

Site Name: Hospital Universitario La Paz
Department Name: Dermatology
Principal Investigator Name: Pedro Francisco Herranz Pinto
Principal Investigator Email: pherranzp@gmail.com
Contact Person Name: Pedro Francisco Herranz Pinto
Contact Person Email: pherranzp@gmail.com

Site Name: Hospital Universitario Puerta De Hierro De Majadahonda
Department Name: Dermatology
Principal Investigator Name: Angel Manuel Rosell Diaz
Principal Investigator Email: angelmanuel.rosell@salud.madrid.org
Contact Person Name: Angel Manuel Rosell Diaz
Contact Person Email: angelmanuel.rosell@salud.madrid.org

Site Name: Hospital General Universitario Dr. Balmis
Department Name: Dermatology Department
Principal Investigator Name: Juan Francisco Silvestre
Principal Investigator Email: silvestre.jfr@gmail.com
Contact Person Name: Juan Francisco Silvestre
Contact Person Email: silvestre.jfr@gmail.com

Germany

Earliest CTIS Part Ii Submission Date: 14-05-2024
Latest Decision Or Authorization Date: 20-02-2026
Processing Time Days: 647
Number Of Sites: 6
Number Of Participants: 26

Sites

Site Name: Universitaetsklinikum Frankfurt AöR
Department Name: Klinik für Dermatologie, Venerologie und Allergologie Klinische Forschung
Principal Investigator Name: Andreas Pinter
Principal Investigator Email: pinter-klifo-ffm@gmx.de
Contact Person Name: Andreas Pinter
Contact Person Email: pinter-klifo-ffm@gmx.de

Site Name: Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Principal Investigator Name: Michael Sebastian
Principal Investigator Email: m.sebastian@derma-mahlow.de
Contact Person Name: Michael Sebastian
Contact Person Email: m.sebastian@derma-mahlow.de

Site Name: University Of Luebeck
Department Name: "Klinik fur Dermatologie, Allergologie und Venerologie, Institut fur Entzundungsmedizin"
Principal Investigator Name: Diamant Thaci
Principal Investigator Email: diamant.thaci@uksh.de
Contact Person Name: Diamant Thaci
Contact Person Email: diamant.thaci@uksh.de

Site Name: Hautarztpraxis Dr Med Matthias Hoffmann
Principal Investigator Name: Matthias Hoffmann
Principal Investigator Email: drho@hautarzt-dr-hoffmann.de
Contact Person Name: Matthias Hoffmann
Contact Person Email: drho@hautarzt-dr-hoffmann.de

Site Name: Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name: Klinik und Poliklinik fur Dermatologie
Principal Investigator Name: Roland Aschoff
Principal Investigator Email: roland.aschoff@uniklinikum-dresden.de
Contact Person Name: Roland Aschoff
Contact Person Email: roland.aschoff@uniklinikum-dresden.de

Site Name: Charite Universitaetsmedizin Berlin KöR
Department Name: Klinik fur Dermatologie, Venerologie und Allergologie
Principal Investigator Name: Margitta Worm
Principal Investigator Email: margitta.worm@charite.de
Contact Person Name: Margitta Worm
Contact Person Email: margitta.worm@charite.de

Netherlands

Earliest CTIS Part Ii Submission Date: 06-05-2024
Latest Decision Or Authorization Date: 13-10-2025
Processing Time Days: 525
Number Of Sites: 2
Number Of Participants: 2

Sites

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: Dermatology Department
Principal Investigator Name: DirkJan Hijnen
Principal Investigator Email: d.hijnen@erasmusmc.nl
Contact Person Name: DirkJan Hijnen
Contact Person Email: d.hijnen@erasmusmc.nl

Site Name: Universitair Medisch Centrum Utrecht
Department Name: Department of Dermatology
Principal Investigator Name: Inge Haeck
Principal Investigator Email: I.M.Haeck-2@umcutrecht.nl
Contact Person Name: Inge Haeck
Contact Person Email: I.M.Haeck-2@umcutrecht.nl

Poland

Earliest CTIS Part Ii Submission Date: 09-05-2024
Latest Decision Or Authorization Date: 22-02-2026
Processing Time Days: 654
Number Of Sites: 5
Number Of Participants: 12

Sites

Site Name: Velocity Nova Sp. z o.o.
Principal Investigator Name: Daria Przybylska
Principal Investigator Email: dr.przybylska@gmail.com
Contact Person Name: Daria Przybylska
Contact Person Email: dr.przybylska@gmail.com

Site Name: Centrum Badan Klinicznych Pi-House Sp. z o.o.
Principal Investigator Name: Aleksandra Okuniewska
Principal Investigator Email: a.okuniewska@pihouse.pl
Contact Person Name: Aleksandra Okuniewska
Contact Person Email: a.okuniewska@pihouse.pl

Site Name: Wromedica I Bielicka A Strzalkowska s.c.
Principal Investigator Name: Wojciech Baran
Principal Investigator Email: wojciech.baran@umed.wroc.pl
Contact Person Name: Wojciech Baran
Contact Person Email: wojciech.baran@umed.wroc.pl

Site Name: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name: Klinika Dermatologii
Principal Investigator Name: Irena Walecka-Herniczek
Principal Investigator Email: irena.walecka@cskmswia.gov.pl
Contact Person Name: Irena Walecka-Herniczek
Contact Person Email: irena.walecka@cskmswia.gov.pl

Site Name: Clinical Research Group Sp. z o.o.
Principal Investigator Name: Kamila Padlewska
Principal Investigator Email: kamila@padlewska.com
Contact Person Name: Kamila Padlewska
Contact Person Email: kamila@padlewska.com

France

Earliest CTIS Part Ii Submission Date: 08-05-2024
Latest Decision Or Authorization Date: 18-02-2026
Processing Time Days: 651
Number Of Sites: 8
Number Of Participants: 13

Sites

Site Name: CHU De Rouen
Department Name: service de dermatologie
Principal Investigator Name: Florence Tetart
Principal Investigator Email: florence.tetart@chu-rouen.fr
Contact Person Name: Florence Tetart
Contact Person Email: florence.tetart@chu-rouen.fr

Site Name: University Hospital Of Clermont-Ferrand
Department Name: service de dermatologie
Principal Investigator Name: Justine Pasteur
Principal Investigator Email: jpasteur@chu-clermontferrand.fr
Contact Person Name: Justine Pasteur
Contact Person Email: jpasteur@chu-clermontferrand.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Dermatologie
Principal Investigator Name: Christine Bodemer
Principal Investigator Email: christine.bodemer@aphp.fr
Contact Person Name: Christine Bodemer
Contact Person Email: christine.bodemer@aphp.fr

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: service de dermatologie
Principal Investigator Name: Julien Seneschal
Principal Investigator Email: julien.seneschal@chu-bordeaux.fr
Contact Person Name: Julien Seneschal
Contact Person Email: julien.seneschal@chu-bordeaux.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Dermatologie
Principal Investigator Name: Khaled Ezzedine
Principal Investigator Email: khaled.ezzedine@aphp.fr
Contact Person Name: Khaled Ezzedine
Contact Person Email: khaled.ezzedine@aphp.fr

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: service de dermatologie
Principal Investigator Name: Delphine Staumont-Salle
Principal Investigator Email: delphine.salle@chru-lille.fr
Contact Person Name: Delphine Staumont-Salle
Contact Person Email: delphine.salle@chru-lille.fr

Site Name: Centre Hospitalier Universitaire De La Reunion
Department Name: Service de Dermatologie
Principal Investigator Name: Antoine Bertolotti
Principal Investigator Email: antoine.bertolotti@chu-reunion.fr
Contact Person Name: Antoine Bertolotti
Contact Person Email: antoine.bertolotti@chu-reunion.fr

Site Name: Centre D'Etude De La Peau Et Du Cheveu
Department Name: Service de Dermatologie
Principal Investigator Name: Mira Pavlovic-Ganascia
Principal Investigator Email: m.pavlovic-ganascia@centresabouraud.fr
Contact Person Name: Mira Pavlovic-Ganascia
Contact Person Email: m.pavlovic-ganascia@centresabouraud.fr

Sponsor

Primary sponsor

Full Name: Sanofi-Aventis Recherche & Developpement
Organisation Type: Pharmaceutical company
Country Of Registered Address: France

Contract research organisations

Name: Pharmaceutical Product Development LLC
Responsibilities: sponsorDuties code: 14

Name: Endpoint Clinical Inc.
Responsibilities: sponsorDuties code: 3

Name: Fisher Clinical Services UK Limited
Responsibilities: sponsorDuties code: 14

Name: Signant Health Management Limited
Responsibilities: sponsorDuties code: 7

Third parties

{"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Let Me Pay Sp. z o.o.","duties_or_roles":"Patient travel cost reimbursment","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"sponsorDuties code: 15 (Centralized 24-Hour Emergency System: eSMS)","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
{"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: Amlitelimab
Active Substance: AMLITELIMAB
Modality: Monoclonal antibody
Routes Of Administration: SUBCUTANEOUS INJECTION
Route: SUBCUTANEOUS INJECTION
Authorisation Status: prodAuthStatus: 1
Maximum Dose: 1250 mg

Investigational Product Name: Placebo
Modality: Other

Combination Treatment: Yes

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