Clinical trial • Phase II • Dermatology
GHZ339 for Atopic dermatitis (moderate to severe)
Phase II trial of GHZ339 for Atopic dermatitis (moderate to severe).
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Atopic dermatitis (moderate to severe)
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 02-06-2025
- First CTIS Authorization Date
- 22-09-2025
Trial design
Randomised, placebo to ghz339 (matching placebo). auxiliary topical medicinal products (topical corticosteroids of various potencies, pimecrolimus, tacrolimus) are listed as auxiliary products in the protocol and may be used per study procedures.-controlled Phase II trial across 52 sites in Germany, Hungary, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo to GHZ339 (matching placebo). Auxiliary topical medicinal products (topical corticosteroids of various potencies, pimecrolimus, tacrolimus) are listed as auxiliary products in the protocol and may be used per study procedures.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 124
Eligibility
Recruits 124 Vulnerable population flag selected. Consent must be provided by the participant: inclusion criterion states "Able and willing to sign the informed consent". Subject information/informed consent forms (Main ICF) are provided for adults in multiple languages (documents available in German, English, Hungarian, Spanish, Italian, Polish, Slovak, Czech, French, Dutch). No assent or minor/parental consent procedures are described in the available materials..
- Vulnerable Population
- Vulnerable population flag selected. Consent must be provided by the participant: inclusion criterion states "Able and willing to sign the informed consent". Subject information/informed consent forms (Main ICF) are provided for adults in multiple languages (documents available in German, English, Hungarian, Spanish, Italian, Polish, Slovak, Czech, French, Dutch). No assent or minor/parental consent procedures are described in the available materials.
Inclusion criteria
- {"criterion_text":"- Able and willing to sign the informed consent"}
- {"criterion_text":"- Patients with a diagnosis of AD and onset of disease for at least 1 year"}
- {"criterion_text":"- Moderate to severe AD"}
- {"criterion_text":"- History of inadequate response to treatment with topical medications or for whom topical treatments are medically inadvisable as per Investigator judgement"}
Exclusion criteria
- {"criterion_text":"- Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)"}
- {"criterion_text":"- Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG"}
- {"criterion_text":"- Participant with any other active inflammatory skin disease"}
- {"criterion_text":"- Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)"}
- {"criterion_text":"- Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma"}
- {"criterion_text":"- Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage change from baseline in the EASI score at Week 16","definition_or_measurement_approach":"Percent change from baseline in the Eczema Area and Severity Index (EASI) score measured at Week 16 vs baseline."}
Secondary endpoints
- {"endpoint_text":"- IGA response at Week 16: IGA score of 0 (clear) or 1 (almost clear) and at least 2 points reduction from baseline IGA response at Week 16","definition_or_measurement_approach":"Investigator Global Assessment (IGA) response defined as IGA = 0 or 1 AND ≥2 point reduction from baseline at Week 16."}
- {"endpoint_text":"- EASI-75 response at Week 16: ≥75% reduction (improvement) from baseline in EASI score response at Week 16","definition_or_measurement_approach":"Proportion of participants with ≥75% reduction from baseline in EASI at Week 16 (EASI-75)."}
- {"endpoint_text":"- Treatment emergent adverse events, vital signs, ECG, and laboratory assessments","definition_or_measurement_approach":"Standard safety assessments including recording of treatment-emergent adverse events (TEAEs), vital signs, ECGs, and clinical laboratory tests."}
Recruitment
- Planned Sample Size
- 124
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent obtained from participants themselves; inclusion requires participants to be "Able and willing to sign the informed consent." Subject information and main informed consent forms for adults are provided in multiple languages (German, English, Hungarian, Spanish, Italian, Polish, Slovak, Czech, French, Dutch). No assent process for minors or parental consent materials are present in the available documents.
Geography
- Total Number Of Sites
- 52
- Total Number Of Participants
- 104
Germany
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 9
- Number Of Sites
- 11
- Number Of Participants
- 18
Sites
- Site Name
- Universitaet Muenster
- Department Name
- 2211:Klinik für Hautkrankheiten
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- Nina.Magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- Nina.Magnolo@ukmuenster.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- 2203:Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen (IVDP)
- Principal Investigator Name
- Matthias Augustin
- Principal Investigator Email
- m.augustin@uke.de
- Contact Person Name
- Matthias Augustin
- Contact Person Email
- m.augustin@uke.de
- Site Name
- Praxis Fuer Dermatologie Und Venerologie
- Department Name
- 2202: Dermatologie
- Principal Investigator Name
- Beatrice Gerlach
- Principal Investigator Email
- dr.b.gerlach@t-online.de
- Contact Person Name
- Beatrice Gerlach
- Contact Person Email
- dr.b.gerlach@t-online.de
- Site Name
- BAG Dres. Med. Quist PartG
- Department Name
- 2207: Dermatologie Quist
- Principal Investigator Name
- Sven Quist
- Principal Investigator Email
- s.quist@dermatologie-quist.de
- Contact Person Name
- Sven Quist
- Contact Person Email
- s.quist@dermatologie-quist.com
- Site Name
- Goethe University Frankfurt
- Department Name
- 2205 :Klinik für Dermatologie, Venerologie und Allergologie
- 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
- Klinische Forschung Osnabrueck
- Department Name
- 2208:NA
- Principal Investigator Name
- Sylvia Pauser
- Principal Investigator Email
- sylvia.pauser@klifos.de
- Contact Person Name
- Sylvia Pauser
- Contact Person Email
- sylvia.pauser@klifos.de
- Site Name
- Thermalsole und Schwefelbad Bentheim GmbH
- Department Name
- 2201:Dermatologie
- Principal Investigator Name
- Athanasios Tsianakas
- Principal Investigator Email
- a.tsianakas@fk-bentheim.de
- Contact Person Name
- Athanasios Tsianakas
- Contact Person Email
- a.tsianakas@fk-bentheim.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- 2206:Universitaetshautklinik
- Principal Investigator Name
- Thomas Tueting
- Principal Investigator Email
- thomas.tueting@med.ovgu.de
- Contact Person Name
- Thomas Tueting
- Contact Person Email
- thomas.tueting@med.ovgu.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- 2212:Klinik fuer Dermatologie, Venerologie u. Allergologie
- Principal Investigator Name
- Timo Buhl
- Principal Investigator Email
- Timo.buhl@med.uni-goettingen.de
- Contact Person Name
- Timo Buhl
- Contact Person Email
- Timo.buhl@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 2204:Hautklinik
- Principal Investigator Name
- Knut Schaekel
- Principal Investigator Email
- Knut.schaekel@med.uni-heidelberg.de
- Contact Person Name
- Knut Schaekel
- Contact Person Email
- Knut.schaekel@med.uni-heidelberg.de
- Site Name
- Klinikum Oldenburg AöR
- Department Name
- 2209:Universitaetsklinik für Dermatologie und Allergologi
- Principal Investigator Name
- Nikolaos Patsinakidis
- Principal Investigator Email
- patsinakidis.nikolaos@klinikum-oldenburg.de
- Contact Person Name
- Nikolaos Patsinakidis
- Contact Person Email
- patsinakidis.nikolaos@klinikum-oldenburg.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 09-09-2025
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 14
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- Semmelweis University
- Department Name
- 2304: Bőr-,Nemikórtani és Bőronkológiai Klinika
- Principal Investigator Name
- Péter Holló
- Principal Investigator Email
- hollo.peter@semmelweis.hu
- Contact Person Name
- Péter Holló
- Contact Person Email
- hollo.peter@semmelweis.hu
- Site Name
- University Of Pecs
- Department Name
- 2301: Bőr-,Nemikórtani és Onkodermatológiai Klinika
- Principal Investigator Name
- Zsuzsanna Lengyel
- Principal Investigator Email
- lengyel.zsuzsanna@pte.hu
- Contact Person Name
- Zsuzsanna Lengyel
- Contact Person Email
- lengyel.zsuzsanna@pte.hu
- Site Name
- University Of Szeged
- Department Name
- 2302: Bőrgyógyászati és Allergológiai Klinika
- Principal Investigator Name
- Nóra Belső
- Principal Investigator Email
- belso.nora@med.u-szeged.hu
- Contact Person Name
- Nóra Belső
- Contact Person Email
- belso.nora@med.u-szeged.hu
- Site Name
- Clinexpert Kft.
- Department Name
- 2303, Clinexpert Óbuda Egészségcentruma
- Principal Investigator Name
- Dorottya Asboth
- Principal Investigator Email
- dr.asboth.dorottya@gmail.com
- Contact Person Name
- Dorottya Asboth
- Contact Person Email
- dr.asboth.dorottya@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- 2300: Bőrgyógyászati Klinika
- Principal Investigator Name
- Szegedi Andrea
- Principal Investigator Email
- aszegedi@med.unideb.hu
- Contact Person Name
- Szegedi Andrea
- Contact Person Email
- aszegedi@med.unideb.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- #2600, S.O.D. Clinica di Dermatologia
- Principal Investigator Name
- Oriana SIMONETTI
- Principal Investigator Email
- oriana.simonetti@ospedaliriuniti.marche.it
- Contact Person Name
- Oriana SIMONETTI
- Contact Person Email
- oriana.simonetti@ospedaliriuniti.marche.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- #2601, U.O. di DermatologiaDipartimento di Medicina Clinica e Specialistica
- Principal Investigator Name
- Alessandro BORGHI
- Principal Investigator Email
- brglsn1@unife.it
- Contact Person Name
- Alessandro BORGHI
- Contact Person Email
- brglsn1@unife.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- #2603, U.O.C. Dermatologia Dipartimento di Medicina Clinica e Sperimentale
- Principal Investigator Name
- Marco ROMANELLI
- Principal Investigator Email
- m.romanelli@med.unipi.it
- Contact Person Name
- Marco ROMANELLI
- Contact Person Email
- m.romanelli@med.unipi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 24-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 7
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- 2803:Dermatología
- Principal Investigator Name
- José Manuel Carrascosa Carrillo
- Principal Investigator Email
- jmcarrascosac.germanstrias@gencat.cat
- Contact Person Name
- José Manuel Carrascosa Carrillo
- Contact Person Email
- jmcarrascosac.germanstrias@gencat.cat
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- 2801:Dermatología
- Principal Investigator Name
- Juan Francisco Silvestre Salvador
- Principal Investigator Email
- silvestre.jfr@gmail.com
- Contact Person Name
- Juan Francisco Silvestre Salvador
- Contact Person Email
- silvestre.jfr@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Pontevedra
- Department Name
- 2800:Dermatología
- Principal Investigator Name
- Maria Teresa Abalde Pintos
- Principal Investigator Email
- teresa.abalde.pintos@sergas.es
- Contact Person Name
- Maria Teresa Abalde Pintos
- Contact Person Email
- teresa.abalde.pintos@sergas.es
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- 2804:Dermatología
- Principal Investigator Name
- Pablo Chicharro Manso
- Principal Investigator Email
- somniem@gmail.com
- Contact Person Name
- Pablo Chicharro Manso
- Contact Person Email
- somniem@gmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- 2806:Dermatología
- Principal Investigator Name
- Alicia González Quesada
- Principal Investigator Email
- ali_gq@hotmail.com
- Contact Person Name
- Alicia González Quesada
- Contact Person Email
- ali_gq@hotmail.com
- Site Name
- Hospital Universitario Clinico San Cecilio
- Department Name
- 2805:Dermatología
- Principal Investigator Name
- Francisco Navarro Triviño
- Principal Investigator Email
- fntmed@gmail.com
- Contact Person Name
- Francisco Navarro Triviño
- Contact Person Email
- fntmed@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 2802:Dermatología
- Principal Investigator Name
- Fátima Tous Romero
- Principal Investigator Email
- fatima.tous@salud.madrid.org
- Contact Person Name
- Fátima Tous Romero
- Contact Person Email
- fatima.tous@salud.madrid.org
Czechia
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 197
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Fakultni Nemocnice Motol A Homolka
- Department Name
- 2000: Dermatovenerologicke oddeleni
- Principal Investigator Name
- Alena Machovcova
- Principal Investigator Email
- alena.machovcova@fnmotol.cz
- Contact Person Name
- Alena Machovcova
- Contact Person Email
- alena.machovcova@fnmotol.cz
- Site Name
- Fakultni Nemocnice Bulovka
- Department Name
- 2002 :Dermatovenerologicka klinika FNB a 2. LF UK
- Principal Investigator Name
- Filib Rob
- Principal Investigator Email
- filip.rob@bulovka.cz
- Contact Person Name
- Filib Rob
- Contact Person Email
- filip.rob@bulovka.cz
- Site Name
- Fakultni Nemocnice Plzen
- Department Name
- 2003 :Dermatovenerologicka klinika, Edvarda Benese
- Principal Investigator Name
- Petra Cetkovska
- Principal Investigator Email
- cetkovska@fnplzen.cz
- Contact Person Name
- Petra Cetkovska
- Contact Person Email
- cetkovska@fnplzen.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- 2001:Dermatovenerologicka klinika 3.LF UK a FNKV
- Principal Investigator Name
- Spyridon Gkalpakiotis
- Principal Investigator Email
- spyridon.gkalpakiotis@fnkv.cz
- Contact Person Name
- Spyridon Gkalpakiotis
- Contact Person Email
- spyridon.gkalpakiotis@fnkv.cz
- Site Name
- Pratia Prague s.r.o.
- Department Name
- 2005:NA
- Principal Investigator Name
- Peter Kicko
- Principal Investigator Email
- peter.kicko@pratia.com
- Contact Person Name
- Peter Kicko
- Contact Person Email
- iva.obstova@pratia.com
France
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 212
- Number Of Sites
- 9
- Number Of Participants
- 15
Sites
- Site Name
- Hopital Saint Louis
- Department Name
- 2105: Dermatology
- Principal Investigator Name
- Marie JACHIET
- Principal Investigator Email
- Marie.jachiet@aphp.fr
- Contact Person Name
- Marie JACHIET
- Contact Person Email
- Marie.jachiet@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- 2102: Dermatology
- Principal Investigator Name
- Sébastien BARBAROT
- Principal Investigator Email
- sebastien.barbarot@chu-nantes.fr
- Contact Person Name
- Sébastien BARBAROT
- Contact Person Email
- sebastien.barbarot@chu-nantes.fr
- Site Name
- Courlancy Sante
- Department Name
- 2108: Dermatology and Clinical research
- Principal Investigator Name
- Ziald REGUIAI
- Principal Investigator Email
- dr-regulal@orange.fr
- Contact Person Name
- Ziald REGUIAI
- Contact Person Email
- dr-regulal@orange.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- 2106: Dermatology
- Principal Investigator Name
- Laurent MISERY
- Principal Investigator Email
- Laurent.misery@chu-brest.fr
- Contact Person Name
- Laurent MISERY
- Contact Person Email
- Laurent.misery@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- 2103: Dermatology
- Principal Investigator Name
- Anne- Bénédicte DUVAL-MODESTE
- Principal Investigator Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Contact Person Name
- Anne- Bénédicte DUVAL-MODESTE
- Contact Person Email
- anne-benedicte.duval-modeste@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- 2104: Dermatology
- Principal Investigator Name
- Thomas HUBICHE
- Principal Investigator Email
- Hubiche.t@chu-nice.fr
- Contact Person Name
- Thomas HUBICHE
- Contact Person Email
- Hubiche.t@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- 2100: Dermatology
- 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
- Hospices Civils De Lyon
- Department Name
- 2101: Allergology and Clinical Immunology
- Principal Investigator Name
- Marie TAUBER
- Principal Investigator Email
- marie.tauber@chu-lyon.fr
- Contact Person Name
- Marie TAUBER
- Contact Person Email
- marie.tauber@chu-lyon.fr
- Site Name
- Groupe Hospitalier Bretagne Sud
- Department Name
- 2107: Dermatology
- Principal Investigator Name
- Caroline JACOBZONE-LEVEQUE
- Principal Investigator Email
- c.jacobzoneleveque@ghbs.bzh
- Contact Person Name
- Caroline JACOBZONE-LEVEQUE
- Contact Person Email
- c.jacobzoneleveque@ghbs.bzh
Netherlands
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 173
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- 2401: Dermatology
- Principal Investigator Name
- Jill De Wit
- Principal Investigator Email
- j.dewit.1@erasmusmc.nl
- Contact Person Name
- Jill De Wit
- Contact Person Email
- j.dewit.1@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- 2400: Dermatology
- Principal Investigator Name
- Marjolein De Bruin-Weller
- Principal Investigator Email
- m.s.debruin-weller@umcutrecht.nl
- Contact Person Name
- Marjolein De Bruin-Weller
- Contact Person Email
- m.s.debruin-weller@umcutrecht.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 230
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Dermoklinika-Medyczne Centrum s.c. M.Kierstan J.Narbutt A.Lesiak
- Department Name
- 2500 : Dermatology
- Principal Investigator Name
- Joanna Narbutt
- Principal Investigator Email
- Joanna.narbutt@onet.pl
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- Joanna.narbutt@onet.pl
- Site Name
- Provita Sp. z o.o.
- Department Name
- 2502 : Dermatology
- Principal Investigator Name
- Anita Lewartowska-Białek
- Principal Investigator Email
- a.lewartowska-bialek@angelius.org
- Contact Person Name
- Anita Lewartowska-Białek
- Contact Person Email
- a.lewartowska-bialek@angelius.org
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Department Name
- 2503 : Dermatology
- Principal Investigator Name
- Justyna Skibinska
- Principal Investigator Email
- PrincipalSkibinska@klinikaambroziak.pl
- Contact Person Name
- Justyna Skibinska
- Contact Person Email
- PrincipalSkibinska@klinikaambroziak.pl
- Site Name
- ROYALDERM Agnieszka Nawrocka
- Department Name
- 2501: Dermatology
- Principal Investigator Name
- Witold Owczarek
- Principal Investigator Email
- Witold.owczarek@dermedicus.pl
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- witold.owczarek@dermedicus.pl
- Site Name
- Luxderm Specjalistyczny Gabinet Dermatologiczny Prof.Dr Hab.N.Med.Dorota Krasowska
- Department Name
- 2504 : Dermatology
- Principal Investigator Name
- Dorota Krasowska
- Principal Investigator Email
- dor.krasowska@gmail.com
- Contact Person Name
- Dorota Krasowska
- Contact Person Email
- dor.krasowska@gmail.com
Slovakia
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 15-04-2026
- Processing Time Days
- 209
- Number Of Sites
- 5
- Number Of Participants
- 11
Sites
- Site Name
- Medikard s.r.o.
- Department Name
- 2701:Kožná ambulancia Youderm
- Principal Investigator Name
- Tomáš Uhrin
- Principal Investigator Email
- tomasuhrin404@gmail.com
- Contact Person Name
- Tomáš Uhrin
- Contact Person Email
- tomasuhrin404@gmail.com
- Site Name
- Alersa s.r.o.
- Department Name
- 2707:Ambulancia klinickej imunológie a alergológie
- Principal Investigator Name
- Daniela Šafčáková
- Principal Investigator Email
- dsafcakova@gmail.com
- Contact Person Name
- Daniela Šafčáková
- Contact Person Email
- dsafcakova@gmail.com
- Site Name
- Alergo H2b s.r.o.
- Department Name
- 2706:Ambulancia klinickej imunológie a alergológie
- Principal Investigator Name
- Svetlana Hadvabova
- Principal Investigator Email
- hadvabova@gmail.com
- Contact Person Name
- Svetlana Hadvabova
- Contact Person Email
- hadvabova@gmail.com
- Site Name
- Maxderm s.r.o.
- Department Name
- 2703:Dermatovenerologická ambulancia
- Principal Investigator Name
- Renata Hodabova
- Principal Investigator Email
- renata.hodabova@gmail.com
- Contact Person Name
- Renata Hodabova
- Contact Person Email
- renata.hodabova@gmail.com
- Site Name
- Univerzitna nemocnica L. Pasteura Kosice
- Department Name
- 2702:Klinika dermatovenerológie
- Principal Investigator Name
- Anna Sepitkova
- Principal Investigator Email
- ankakohutova@centrum.sk
- Contact Person Name
- Anna Sepitkova
- Contact Person Email
- ankakohutova@centrum.sk
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties codes: [1]; contact sm_ctis@syneoshealth.com
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- laboratory services; sponsorDuties codes: [4]; contact CTISApplications-Pharma@iconplc.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- clinical research support; sponsorDuties codes: [1]; contact Triona.PriceSmith1@docsglobal.com
- Name
- Parexel International (IRL) Limited
- Responsibilities
- clinical trial services; sponsorDuties codes: [12]; contact Clinicaltrial.Enquiries@parexel.com
- Name
- IQVIA Limited
- Responsibilities
- multiple services including PRO services and supply/logistics; sponsorDuties codes: [1,13,15,3,7]; contact eu_clinical_trials_information@iqvia.com
- Name
- Medidata Solutions Inc.
- Responsibilities
- data platform/services; sponsorDuties codes: [6]; contact info@medidata.com
Third parties
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Komtur Polska Sp. z o.o.","duties_or_roles":"Local purchase of medicinal products (AxMP)","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local Drug supply with Labeling activity","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products returned from sites to local depot","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"SGS France","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple roles including code(s): [1,13,15,3,7]; PRO services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- GHZ339
- Active Substance
- GHZ339
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- Placebo to GHZ339
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