Clinical trial • Phase III • Dermatology
LEBRIKIZUMAB for Nummular dermatitis
Phase III trial of LEBRIKIZUMAB for Nummular dermatitis.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Nummular dermatitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
Randomised, investigational medicinal product: ebglyss 250 mg solution for injection in pre-filled syringe (lebrikizumab; each single-use pfs contains 250 mg in 2 ml, 125 mg/ml). comparator arm: matching placebo (placebo). schedule/dosing frequency not specified in provided data.-controlled Phase III trial across 52 sites in Bulgaria, Italy, Poland and others.
- Randomised
- Yes
- Comparator
- Investigational medicinal product: Ebglyss 250 mg solution for injection in pre-filled syringe (lebrikizumab; each single-use PFS contains 250 mg in 2 mL, 125 mg/mL). Comparator arm: matching placebo (Placebo). Schedule/dosing frequency not specified in provided data.
- Target Sample Size
- 241
- Trial Duration For Participant
- 168
Eligibility
Recruits 241 Participants are adults (aged 18 years or more); vulnerable populations were not selected. Written informed consent is required: "1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines." No assent process is described..
- Pregnancy Exclusion
- 5. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Vulnerable Population
- Participants are adults (aged 18 years or more); vulnerable populations were not selected. Written informed consent is required: "1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines." No assent process is described.
Inclusion criteria
- {"criterion_text":"- 1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines."}
- {"criterion_text":"- 2. Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator."}
- {"criterion_text":"- 3. Presence of NE signs and/or symptoms for at least 6 months prior to Screening."}
Exclusion criteria
- {"criterion_text":"- 1. Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI ≥16)."}
- {"criterion_text":"- 2. Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis)."}
- {"criterion_text":"- 3. Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis."}
- {"criterion_text":"- 4. History of anaphylaxis as defined by the Sampson criteria."}
- {"criterion_text":"- 5. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study."}
- {"criterion_text":"- 6. History of sensitivity and/or allergy to any of the ingredients of the trial medication."}
- {"criterion_text":"- 7. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Percentage of participants achieving endpoint reduction from baseline at Week 24.","definition_or_measurement_approach":"Proportion of participants achieving a reduction from baseline in the specified endpoint at Week 24 (assessment at Week 24 vs baseline)."}
Secondary endpoints
- {"endpoint_text":"- 1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24","definition_or_measurement_approach":"Proportion of participants with baseline Pruritus NRS ≥4 who achieve a ≥4-point improvement in Pruritus NRS score at Week 24 compared with baseline."}
- {"endpoint_text":"- 2. Absolute change from baseline in DLQI to Week 24.","definition_or_measurement_approach":"Absolute change in Dermatology Life Quality Index (DLQI) score from baseline to Week 24."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 241
- Recruitment Window Months
- 28
- Consent Approach
- Written informed consent is required from participants (adults). Inclusion criterion 1 requires ability to provide written informed consent. Subject information and informed consent forms (SIS-ICF) are provided and redacted for multiple languages (documents L1_BG, L1_IT, L1_DE, L1_ES, L1_PL etc.), indicating ICFs available in Bulgarian, Italian, German, Spanish and Polish. No assent process described.
Methods
- HCP letters (country-specific K2_*_Recruitment Material_HCP Letter documents) — targeted to healthcare professionals to inform about trial (documents available for BG, IT, PL, DE, ES).
- Posters and brochures (K2_*_Recruitment Material_Poster / Brochure) — site posters/brochures for patient recruitment (country-specific: BG, IT, PL, DE, ES).
- Web banner ads (K2_*_Recruitment Material_Web Banner Ads) — digital advertising via web banners (country-specific).
- Facebook Ads (K2_*_Recruitment Material_Facebook Ads) — social media advertising to reach potential participants (country-specific).
- HCP factsheets (K2_*_Recruitment Material_HCP Factsheet) — informational factsheets for clinicians (country-specific).
- SIGAL SMS recruitment text blocks (K2_DE_Recruitment Material_SIGAL SMS recruitment text blocks) — SMS-based recruitment in Germany.
- Recruitment procedures/K1 documents (K1_*_Recruitment Procedure) — country-specific recruitment procedure documents describing local recruitment workflows (available for BG, IT, PL, DE).
Geography
- Total Number Of Sites
- 52
- Total Number Of Participants
- 241
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 38
- Number Of Sites
- 6
- Number Of Participants
- 17
Sites
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Petyo Brezoev
- Principal Investigator Email
- drbrezoev@abv.bg
- Contact Person Name
- Petyo Brezoev
- Contact Person Email
- drbrezoev@abv.bg
- Site Name
- ASMC IPSMC Skin And Venereal Diseases
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Ivan Botev
- Principal Investigator Email
- botev2@yahoo.com
- Contact Person Name
- Ivan Botev
- Contact Person Email
- botev2@yahoo.com
- Site Name
- Diagnostics And Consultancy Center Pulmed EOOD
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Rumyana Yankova
- Principal Investigator Email
- Rumyana.yankova@abv.bg
- Contact Person Name
- Rumyana Yankova
- Contact Person Email
- Rumyana.yankova@abv.bg
- Site Name
- Dkc Fokus-5 Lzip OOD
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Grisha Mateev
- Principal Investigator Email
- grisha_mateev@yahoo.com
- Contact Person Name
- Grisha Mateev
- Contact Person Email
- grisha_mateev@yahoo.com
- Site Name
- Diagnostic And Consulting Center XXVIII-Sofia EOOD
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Katya Zaharieva
- Principal Investigator Email
- zaharieva_doctor@abv.bg
- Contact Person Name
- Katya Zaharieva
- Contact Person Email
- zaharieva_doctor@abv.bg
- Site Name
- Medical Center Femiclinic EOOD
- Department Name
- Dermatology and Venereology
- Principal Investigator Name
- Nadya Tosheva
- Principal Investigator Email
- drtoshevafc@gmail.com
- Contact Person Name
- Nadya Tosheva
- Contact Person Email
- drtoshevafc@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 05-03-2026
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- Dermatologia e Venereologia
- Principal Investigator Name
- Caterina Foti
- Principal Investigator Email
- caterina.foti@uniba.it
- Contact Person Name
- Caterina Foti
- Contact Person Email
- caterina.foti@uniba.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. Dermatologia
- Principal Investigator Name
- Mariateresa Rossi
- Principal Investigator Email
- Mariateresa.rossi@unibs.it
- Contact Person Name
- Mariateresa Rossi
- Contact Person Email
- Mariateresa.rossi@unibs.it
- Site Name
- Azienda Unita Locale Socio Sanitaria N 8 Berica
- Department Name
- Dermatology
- Principal Investigator Name
- Elena Pezzolo
- Principal Investigator Email
- elena.pezzolo@aulss8.veneto.it
- Contact Person Name
- Elena Pezzolo
- Contact Person Email
- elena.pezzolo@aulss8.veneto.it
Poland
- Earliest CTIS Part Ii Submission Date
- 26-11-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 140
- Number Of Sites
- 13
- Number Of Participants
- 82
Sites
- Site Name
- Dermmedica Sp. z o.o.
- Department Name
- CENTRUM COLUMBUS
- Principal Investigator Name
- Jolanta Weglowska
- Principal Investigator Email
- office@dermmedica.pl
- Contact Person Name
- Jolanta Weglowska
- Contact Person Email
- office@dermmedica.pl
- Site Name
- Velocity Nova Sp. z o.o.
- Department Name
- Velocity Skierniewice
- Principal Investigator Name
- Witold Urban
- Principal Investigator Email
- wurban@velocityclinical.com
- Contact Person Name
- Witold Urban
- Contact Person Email
- wurban@velocityclinical.com
- Site Name
- Dermaceum Sp. z o.o.
- Department Name
- DERMACEUM Centrum Medyczne
- Principal Investigator Name
- Michal Torz
- Principal Investigator Email
- m.torz@dermacentrum.pl
- Contact Person Name
- Michal Torz
- Contact Person Email
- m.torz@dermacentrum.pl
- Site Name
- Santa Sp. z o.o.
- Department Name
- Santa Familia PTG Lodz
- Principal Investigator Name
- Agnieszka Holdrowicz
- Principal Investigator Email
- agnieszka.holdrowicz@ptgnetwork.com
- Contact Person Name
- Agnieszka Holdrowicz
- Contact Person Email
- agnieszka.holdrowicz@ptgnetwork.com
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Department Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Principal Investigator Name
- Magdalena Czarnecka-Operacz
- Principal Investigator Email
- kontakt@cr-center.pl
- Contact Person Name
- Magdalena Czarnecka-Operacz
- Contact Person Email
- kontakt@cr-center.pl
- Site Name
- Zdybski Med Sp. z o.o.
- Department Name
- ZDYBSKI MED SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA Zdybski Med KIE
- Principal Investigator Name
- Jacek Zdybski
- Principal Investigator Email
- jacek@zdybski.pl
- Contact Person Name
- Jacek Zdybski
- Contact Person Email
- jacek@zdybski.pl
- Site Name
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
- Department Name
- Centrum Nowoczesnych Terapii "Dobry Lekarz" Spółka z ograniczoną odpowiedzialnością
- Principal Investigator Name
- Malgorzata Dyczek
- Principal Investigator Email
- katarzyna.gajda@dobrylekarz.com.pl
- Contact Person Name
- Malgorzata Dyczek
- Contact Person Email
- katarzyna.gajda@dobrylekarz.com.pl
- Site Name
- Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak
- Department Name
- MCBK
- Principal Investigator Name
- Joanna Rudowska-Okrasko
- Principal Investigator Email
- j.okrasko@mcbk.pl
- Contact Person Name
- Joanna Rudowska-Okrasko
- Contact Person Email
- j.okrasko@mcbk.pl
- Site Name
- Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia PCM
- Principal Investigator Name
- Leszek Bartoszak
- Principal Investigator Email
- bartoszak@twojaprzychodnia.com
- Contact Person Name
- Leszek Bartoszak
- Contact Person Email
- bartoszak@twojaprzychodnia.com
- Site Name
- LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
- Principal Investigator Name
- Dorota Krasowska
- Principal Investigator Email
- dor.krasowska@gmail.com
- Contact Person Name
- Dorota Krasowska
- Contact Person Email
- dor.krasowska@gmail.com
- Site Name
- ETG Lublin Sp. z o.o.
- Department Name
- ETG Lublin
- Principal Investigator Name
- Anna Glowacka
- Principal Investigator Email
- a.glowacka@etg-network.com
- Contact Person Name
- Anna Glowacka
- Contact Person Email
- a.glowacka@etg-network.com
- Site Name
- Gyncentrum Sp. z o.o.
- Department Name
- NZOZ Holsamed-Oddział Libero
- Principal Investigator Name
- Marcin Zakrzewski
- Principal Investigator Email
- m.zakrzewski@gyncentrum.pl
- Contact Person Name
- Marcin Zakrzewski
- Contact Person Email
- m.zakrzewski@gyncentrum.pl
- Site Name
- Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
- Department Name
- CITYCLINIC PRZYCHODNIA LEKARSKOPSYCHOLOGICZNA MATUSIAK SPOLKA PARTNERSKA
- Principal Investigator Name
- Jacek Szepietowski
- Principal Investigator Email
- cityclinic.matusiak@gmail.com
- Contact Person Name
- Jacek Szepietowski
- Contact Person Email
- cityclinic.matusiak@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 12-02-2026
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 90
- Number Of Sites
- 18
- Number Of Participants
- 86
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Dermatologi e und Venerologie
- Principal Investigator Name
- Killian Eyerich
- Principal Investigator Email
- haut.studienzentrum@uniklinik-freiburg.de
- Contact Person Name
- Killian Eyerich
- Contact Person Email
- haut.studienzentrum@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitäts-Hautklinik
- Principal Investigator Name
- Sebastian Volc
- Principal Investigator Email
- Studienzentrum.immundermatologie@med.uni-tuebingen.de
- Contact Person Name
- Sebastian Volc
- Contact Person Email
- Studienzentrum.immundermatologie@med.uni-tuebingen.de
- Site Name
- Klinische Forschung Osnabrueck
- Principal Investigator Name
- Sylvia Pauser
- Principal Investigator Email
- info@klifos.de
- Contact Person Name
- Sylvia Pauser
- Contact Person Email
- info@klifos.de
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- Clinic for Dermatologyand Allergology
- Principal Investigator Name
- Nikolaos Patsinakidis
- Principal Investigator Email
- StudienzentrumDermatologie@Klinikum-Oldenburg.de
- Contact Person Name
- Nikolaos Patsinakidis
- Contact Person Email
- StudienzentrumDermatologie@Klinikum-Oldenburg.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- Clinical Trial Center
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- studien-dermatologie@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- studien-dermatologie@fk-bentheim.de
- Site Name
- Gemeinschaftspraxis Weber/Crainic
- Principal Investigator Name
- Ridwan Weber
- Principal Investigator Email
- info@wedermic.de
- Contact Person Name
- Ridwan Weber
- Contact Person Email
- info@wedermic.de
- Site Name
- Klinikum Bielefeld gGmbH
- Department Name
- Clinic for DermatologyVenerology and Allergology
- Principal Investigator Name
- Katharina Kreutzer
- Principal Investigator Email
- studienzentrum-hautklinik@klinikumbielefeld.de
- Contact Person Name
- Katharina Kreutzer
- Contact Person Email
- studienzentrum-hautklinik@klinikumbielefeld.de
- Site Name
- Studienzentrum Dr. Beate Schwarz
- Department Name
- Dermatology
- Principal Investigator Name
- Beate Schwarz
- Principal Investigator Email
- studie@hautarzt-langenau.de
- Contact Person Name
- Beate Schwarz
- Contact Person Email
- studie@hautarzt-langenau.de
- Site Name
- HzFhS Rossbacher-Spickermann eGbR
- Department Name
- Dermatologie
- Principal Investigator Name
- Jens Rossbacher
- Principal Investigator Email
- studien@hzfh.de
- Contact Person Name
- Jens Rossbacher
- Contact Person Email
- studien@hzfh.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Klinik für Dermatologie, Venerologie und Allergologie (KDVA), Klinische Forschung
- Principal Investigator Name
- Andreas Pinter
- Principal Investigator Email
- andreas.Pinter@unimedizin-ffm.de
- Contact Person Name
- Andreas Pinter
- Contact Person Email
- andreas.Pinter@unimedizin-ffm.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
- Department Name
- Institute for Inflammation Medicine
- 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
- BAG Drs. med. Quist PartG
- Department Name
- Not applicable
- Principal Investigator Name
- Sven Quist
- Principal Investigator Email
- studie@dermatologie-quist.de
- Contact Person Name
- Sven Quist
- Contact Person Email
- studie@dermatologie-quist.de
- Site Name
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Department Name
- Dermatology
- 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
- Dermatologikum Hamburg GmbH
- Department Name
- Not applicable
- Principal Investigator Name
- Peter Weisenseel
- Principal Investigator Email
- info@dermatologikum.de
- Contact Person Name
- Peter Weisenseel
- Contact Person Email
- info@dermatologikum.de
- Site Name
- Hautarztpraxis Dr. Med. Matthias Hoffmann
- Department Name
- Not applicable
- 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 Schleswig-Holstein AöR (Kiel)
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Sascha Gerdes
- Principal Investigator Email
- sgerdes@dermatology.uni-kiel.de
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
- Site Name
- Klinikum Darmstadt GmbH
- Department Name
- Hautklinik
- Principal Investigator Name
- Mana zur Bruegge
- Principal Investigator Email
- hautstudien@mail.klinikum-darmstadt.de
- Contact Person Name
- Mana zur Bruegge
- Contact Person Email
- hautstudien@mail.klinikum-darmstadt.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Clinic of Dermatology
- Principal Investigator Name
- Susanne Abraham
- Principal Investigator Email
- Susanne.abraham@ukdd.de
- Contact Person Name
- Susanne Abraham
- Contact Person Email
- Susanne.abraham@ukdd.de
Spain
- Earliest CTIS Part Ii Submission Date
- 12-02-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 85
- Number Of Sites
- 12
- Number Of Participants
- 31
Sites
- Site Name
- Hospital De Manises
- Department Name
- Dermatology
- Principal Investigator Name
- Antonio Martorell Calatayud
- Principal Investigator Email
- martorell_antcal@gva.es
- Contact Person Name
- Antonio Martorell Calatayud
- Contact Person Email
- martorell_antcal@gva.es
- Site Name
- Hospital General De Granollers
- Department Name
- Dermatology
- Principal Investigator Name
- Antonio Guilabert Vidal
- Principal Investigator Email
- guilabert@fphag.org
- Contact Person Name
- Antonio Guilabert Vidal
- Contact Person Email
- guilabert@fphag.org
- Site Name
- Hospital Universitario La Paz
- Department Name
- Dermatology
- Principal Investigator Name
- Pedro Herranz Pinto
- Principal Investigator Email
- pedro.herranz@salud.madrid.org
- Contact Person Name
- Pedro Herranz Pinto
- Contact Person Email
- pedro.herranz@salud.madrid.org
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- Dermatology
- Principal Investigator Name
- Francisco Jose Navarro Trivino
- Principal Investigator Email
- franciscoj.navarro.trivino.sspa@juntadeandalucia.es
- Contact Person Name
- Francisco Jose Navarro Trivino
- Contact Person Email
- franciscoj.navarro.trivino.sspa@juntadeandalucia.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Jose Juan Pereyra Rodriguez
- Principal Investigator Email
- jpereyra@us.es
- Contact Person Name
- Jose Juan Pereyra Rodriguez
- Contact Person Email
- jpereyra@us.es
- Site Name
- Icr Medical S.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Alvaro Gonzalez Cantero
- Principal Investigator Email
- alvarogc261893@hotmail.com
- Contact Person Name
- Alvaro Gonzalez Cantero
- Contact Person Email
- alvarogc261893@hotmail.com
- Site Name
- Hospital Universitario Basurto
- Department Name
- Dermatology
- Principal Investigator Name
- Rosa Izu Belloso
- Principal Investigator Email
- rosamaria.izubelloso@osakidetza.eus
- Contact Person Name
- Rosa Izu Belloso
- Contact Person Email
- rosamaria.izubelloso@osakidetza.eus
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Principal Investigator Name
- Servando Marron Moya
- Principal Investigator Email
- semarron@aedv.es
- Contact Person Name
- Servando Marron Moya
- Contact Person Email
- semarron@aedv.es
- Site Name
- Accellacare Espana S.L.
- Department Name
- Dermatology
- Principal Investigator Name
- Pablo Miguel Fonda Pascual
- Principal Investigator Email
- pfondap@gmail.com
- Contact Person Name
- Pablo Miguel Fonda Pascual
- Contact Person Email
- pfondap@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Dermatology
- Principal Investigator Name
- María Bibiana Perez García
- Principal Investigator Email
- bibianapg1@gmail.com
- Contact Person Name
- María Bibiana Perez García
- Contact Person Email
- bibianapg1@gmail.com
- Site Name
- Hospital Marina Baixa De La Vila Joiosa
- Department Name
- Dermatology
- Principal Investigator Name
- Francisco Mataix Diaz
- Principal Investigator Email
- mataixdiaz@hotmail.com
- Contact Person Name
- Francisco Mataix Diaz
- Contact Person Email
- mataixdiaz@hotmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Dermatology
- Principal Investigator Name
- Juan Alberto Ruano Ruiz
- Principal Investigator Email
- juanruanoruiz@mac.com
- Contact Person Name
- Juan Alberto Ruano Ruiz
- Contact Person Email
- juanruanoruiz@mac.com
Sponsor
Primary sponsor
- Full Name
- Almirall S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Contract research organisations
- Name
- Icon (Lr) Limited
- Responsibilities
- codes: 1,10,11,12,13,15 (Imaging, PCO),2,3,4,5,6,8,9
Third parties
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"codes: 1,10,11,12,13,15 (Imaging, PCO),2,3,4,5,6,8,9","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"codes: 6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"codes: 15 (value: PK),4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"codes: 15 (value: Patient reimubrsement)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"ArtiQ","duties_or_roles":"codes: 6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"codes: 6,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"codes: 6,7","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fulgent Genetics Inc.","duties_or_roles":"codes: 15 (value: Biomarker testing and storage)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"codes: 6,7","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Bioclinica Shanghai Co. Ltd.","duties_or_roles":"codes: 6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"codes: 15 (value: PK testing and storage),4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioClinica GmbH","duties_or_roles":"codes: 6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Exco Intouch Limited","duties_or_roles":"codes: 6,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Precision For Medicine (UK) Limited","duties_or_roles":"codes: 15 (value: Skin biopsy testing and storage),4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ebglyss 250 mg solution for injection in pre-filled syringe
- Active Substance
- LEBRIKIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Marketing authorisation EU/1/23/1765/001 (prodAuthStatus 2)
- Starting Dose
- 250 mg (each single-use pre-filled syringe contains 250 mg in 2 mL; 125 mg/mL)
- Investigational Product Name
- Placebo
- Modality
- Other
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