Clinical trial • Phase III • Dermatology

ROCATINLIMAB for Prurigo nodularis

Phase III trial of ROCATINLIMAB for Prurigo nodularis.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Prurigo nodularis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
28-06-2024
First CTIS Authorization Date
11-10-2024

Trial design

Randomised, open-label, placebo for amg 451 (matching placebo); dose and schedule not specified in the available ctis record.-controlled Phase III trial in Austria, France, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo for AMG 451 (matching placebo); dose and schedule not specified in the available CTIS record.
Target Sample Size
277
Trial Duration For Participant
364

Eligibility

Recruits 277 No vulnerable population selected. Participants must provide informed consent before initiation of any study-specific activities/procedures; minimum age ≥ 18 years (or the legal age in the country if older). No assent procedures for minors (minors are excluded)..

Vulnerable Population
No vulnerable population selected. Participants must provide informed consent before initiation of any study-specific activities/procedures; minimum age ≥ 18 years (or the legal age in the country if older). No assent procedures for minors (minors are excluded).

Inclusion criteria

  • {"criterion_text":"- Participant has provided informed consent before initiation of any study-specific activities/procedures.\n- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n- A clinical diagnosis of prurigo nodularis (as defined by core symptoms according to the United States expert panel consensus [Elmariah et al, 2021]), that has been present for at least 3 months before signing of informed consent. The prurigo nodularis defined core symptoms include pruritus for more than 6 weeks, evidence of chronic scratching, and presence of multiple pruriginous lesions and excoriated nodules.\n- Patient-reported average itching score based on electronic daily diary assessment the last 7 days prior to day 1, at day 1 prerandomization.\n- Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs, and/or both arms and/or trunk at initial screening and at day 1 prerandomization.\n- Prior to informed consent, history of inadequate response topical therapies for prurigo nodularis or for whom topical therapies is otherwise medically inadvisable (eg, because of important side effects or safety risks). - Inadequate response is defined as inability to achieve and/or maintain a low disease state despite treatment with a daily regimen of topical therapies, - Participants with any previous systemic treatment or phototherapy for prurigo nodularis or topical Janus kinase (JAK) inhibitors for prurigo nodularis, independent of response, are also considered as inadequate responders and are potentially eligible to be included in the study after appropriate washout.\n- Participants must have completed at least 4 days of daily diary entries within the 7 days preceding and including day 1 prerandomization."}

Exclusion criteria

  • {"criterion_text":"- Skin or systemic morbidities, other than prurigo nodularis, that have been active or requiring treatment within the last 3 months, prior to screening that interfere with the assessment of study outcomes\n- Any of the following laboratory abnormalities at initial screening: - eGFR < 30 mL/min/1.73 m2 - AST or ALT: ≥ 2.5 times the upper limit of normal (ULN) - neutrophil count: < 1.5 x 103/µL\n- Diagnosis of a helminth parasitic infection within 6 months prior to day 1 prerandomization that had not been treated with or had failed to respond to standard of care therapy.\n- Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals within the specified time period before day 1 prerandomization.\n- History of New York Heart Association class III/IV heart failure; diagnosis of uncontrolled hypertension at initial screening; or inadequately treated cardiovascular conditions at initial screening including: cardiomyopathy, major congenital heart disease, or second or third-degree atrioventricular block.\n- Recent cardiovascular events including cerebrovascular accident, myocardial infarction, coronary stenting, or unstable angina within 6 months of day 1 prerandomization\n- Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.\n- Positive for HCV antibody at initial screening with confirmed positive HCV RNA.\n- Chronic hepatitis B infection at initial screening, defined as detectable HBsAg or HBV DNA.Participants with detectable anti-HBc and negative HBsAg/HBV DNA are required to do on-study HBV DNA monitoring.\n- Active or latent tuberculosis infection as evident by positive or indeterminate QuantiFERON GOLD from central laboratory at initial screening and assessed at day 1 prerandomization per Screening TB Risk Assessment Questionnaire provided by Amgen.\n- A corrected QT interval (QTc ) of > 450 msec in males of > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome.\n- History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.\n- History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted,would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.\n- Prurigo nodularis secondary to medications.\n- Prurigo nodularis secondary to neurologic or psychiatric medical conditions\n- Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent\n- Superficial skin infection within 2 weeks before day 1 prerandomization.\n- Known sensitivity to any of the products or components to be administered during dosing.\n- Major psychiatric illness,within 1 year before day 1 prerandomization.\n- Inpatient psychiatric admission within 1 year before day 1 prerandomization.\n- Change in psychiatric medication for a psychiatric illness within 8 weeks before day 1 prerandomization.\n- Anticipated need to change psychiatric medication for a psychiatric illness during the study.\n- History of alcohol or substance abuse within 6 months prior to initial screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achieving reduction from baseline in weekly average of daily itching score at specified time points.","definition_or_measurement_approach":"Weekly average of daily itching score measured by a patient-reported electronic daily diary (PRO) comparing change from baseline at specified timepoints."}

Secondary endpoints

  • {"endpoint_text":"- Improvement in investigator assessment of PN lesions","definition_or_measurement_approach":"Investigator's clinical assessment of prurigo nodularis lesions (investigator-rated lesion improvement) at specified timepoints."}
  • {"endpoint_text":"- Improvement in daily itching from baseline.","definition_or_measurement_approach":"Change from baseline in daily itching score (PRO, electronic daily diary), typically assessed as weekly averages at specified timepoints."}
  • {"endpoint_text":"- Improvement in daily skin pain from baseline","definition_or_measurement_approach":"Change from baseline in patient-reported daily skin pain (PRO) at specified timepoints."}
  • {"endpoint_text":"- Change in quality of life from baseline.","definition_or_measurement_approach":"Change from baseline in quality-of-life measure(s) (instrument unspecified in the public record) at specified timepoints."}
  • {"endpoint_text":"- Change in sleep disturbance from baseline","definition_or_measurement_approach":"Change from baseline in sleep disturbance (patient-reported) at specified timepoints."}
  • {"endpoint_text":"- Treatment-emergent adverse events , adverse events of special interest, and serious adverse events","definition_or_measurement_approach":"Safety endpoints captured as incidence and characterization of treatment-emergent adverse events (TEAEs), AEs of special interest (AESI), and serious adverse events (SAEs) per standard safety reporting procedures."}

Recruitment

Digital Remote Recruitment
True, includes website ads, online recruitment materials, and cloud-based pre-screening/enrollment management (Reify Health Inc.)
Planned Sample Size
277
Recruitment Window Months
29
Consent Approach
Informed consent must be provided by the participant prior to any study-specific procedures. Minimum age is ≥18 years (or legal age in the country if older). Multiple language subject information and informed consent forms are provided (English and multiple EU languages as per published ICF documents). Pregnancy-specific consent/follow-up documents are provided for relevant participants. No assent for minors since minors are excluded.

Methods

  • Physician referral / Dr-to-Dr letters (Physician Referral Letter documents listed)
  • GP/physician letters (GP letter recruitment material)
  • Website advertisements (documents: Website ad / Website ad_09Dec2024)
  • Advertisement flyers (Recruitment Material_Advertisement flyer)
  • Cloud-based pre-screening and enrollment management (Reify Health Inc. listed role: cloud-based pre-screening and enrollment management)
  • Site-based recruitment (local site recruitment procedures/K1 Recruitment arrangements documents)

Geography

Total Number Of Sites
73
Total Number Of Participants
277

Austria

Earliest CTIS Part Ii Submission Date
11-07-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
447
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Medical University Of Graz
Department Name
Dermatology
Principal Investigator Name
Franz Legat
Principal Investigator Email
franz.legat@medunigraz.at
Contact Person Name
Franz Legat
Contact Person Email
franz.legat@medunigraz.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Dermatology
Principal Investigator Name
Barbara Ebner
Principal Investigator Email
barbara.ebner@ordensklinikum.at
Contact Person Name
Barbara Ebner

France

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
388
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Dermatology Department
Principal Investigator Name
Thierrry Passeron
Principal Investigator Email
passeron.t@chu-nice.fr
Contact Person Name
Thierrry Passeron
Contact Person Email
passeron.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Onco-Dermatology
Principal Investigator Name
Anne-Benedicte Duval-Modeste
Principal Investigator Email
anne-benedicte.duval-modeste@chu-rouen.fr
Contact Person Name
Anne-Benedicte Duval-Modeste
Site Name
Du Docteur Ruer S.E.L.A.R.L.
Department Name
Dermatology Department
Principal Investigator Name
Mireille Ruer
Principal Investigator Email
ruerdoc@gmail.com
Contact Person Name
Mireille Ruer
Contact Person Email
ruerdoc@gmail.com
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Dermatology Department
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 Le Mans
Department Name
Dermatology Department
Principal Investigator Name
Nathalie Beneton
Principal Investigator Email
nbeneton@ch-lemans.fr
Contact Person Name
Nathalie Beneton
Contact Person Email
nbeneton@ch-lemans.fr

Belgium

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
388
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
UZ Leuven
Department Name
Dermatologie
Principal Investigator Name
Tom Hillary
Principal Investigator Email
tom.hillary@uzleuven.be
Contact Person Name
Tom Hillary
Contact Person Email
tom.hillary@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatologie
Principal Investigator Name
Pierre-Dominique Ghislain
Principal Investigator Email
Pierre-Dominique.Ghislain@uclouvain.be
Contact Person Name
Pierre-Dominique Ghislain
Site Name
Centre hospitalier universitaire de Liege
Department Name
Dermatologie
Principal Investigator Name
Arjen Nikkels
Principal Investigator Email
af.nikkels@chuliege.be
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be

Sweden

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
377
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Uppsala University Hospital
Department Name
Dermatology
Principal Investigator Name
Eniko Sonkoly
Principal Investigator Email
eniko.sonkoly@medsci.uu.se
Contact Person Name
Eniko Sonkoly
Contact Person Email
eniko.sonkoly@medsci.uu.se
Site Name
Diagnostiskt Centrum Hud i Sickla AB
Department Name
Diagnostiskt Centrum Hud i Sickla
Principal Investigator Name
Lucian Grema
Principal Investigator Email
lucian.grema@dchud.se
Contact Person Name
Lucian Grema
Contact Person Email
lucian.grema@dchud.se

Latvia

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
377
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Veselibas Centrs 4 SIA (Grebenscikova Iela 1)
Department Name
Outpatient clinic Veselibas Centrs 4
Principal Investigator Name
Diana Viba
Principal Investigator Email
diana.viba@gmail.com
Contact Person Name
Diana Viba
Contact Person Email
diana.viba@gmail.com
Site Name
Veselibas Centrs 4 SIA (Skanstes Iela 50)
Department Name
Dermatology and Surgery clinic
Principal Investigator Name
Vita Priedite
Principal Investigator Email
vitaskanste@gmail.com
Contact Person Name
Vita Priedite
Contact Person Email
vitaskanste@gmail.com
Site Name
J.Kisis SIA
Department Name
NAP
Principal Investigator Name
Ilona Radionova
Principal Investigator Email
dr.i.radionova@gmail.com
Contact Person Name
Ilona Radionova
Contact Person Email
dr.i.radionova@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
20-09-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
377
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
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

Greece

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
426
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
A' Dermatology and Venereology Clinic
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
1st Department of Dermatology and Venereology
Principal Investigator Name
Alexander Stratigos
Principal Investigator Email
alstrat2@gmail.com
Contact Person Name
Alexander Stratigos
Contact Person Email
alstrat2@gmail.com
Site Name
General Hospital Of Nea Ionia Konstantopouleio Patision
Department Name
Dermatology Department
Principal Investigator Name
Ourania Neofotistou
Principal Investigator Email
ranneof@gmail.com
Contact Person Name
Ourania Neofotistou
Contact Person Email
ranneof@gmail.com
Site Name
University General Hospital Attikon
Department Name
2nd Department of Dermatology-Venereology
Principal Investigator Name
Alexandros Katoulis
Principal Investigator Email
alexanderkatoulis@yahoo.co.uk
Contact Person Name
Alexandros Katoulis
Contact Person Email
alexanderkatoulis@yahoo.co.uk
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
2nd Department of Dermatology-Venereology
Principal Investigator Name
Elisavet Lazaridou
Principal Investigator Email
bethlaz@auth.gr
Contact Person Name
Elisavet Lazaridou
Contact Person Email
bethlaz@auth.gr

Finland

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
377
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
CRST Helsinki Oy
Department Name
Technopolis 3
Principal Investigator Name
Johanna Mandelin
Principal Investigator Email
johanna.mandelin@hus.fi
Contact Person Name
Johanna Mandelin
Contact Person Email
johanna.mandelin@hus.fi
Site Name
Suomen Terveystalo Oy
Department Name
Terveystalo Tampere
Principal Investigator Name
Rafael Pasternack
Principal Investigator Email
Rafael.pasternack@terveystalo.com
Contact Person Name
Rafael Pasternack
Site Name
Oulu University Hospital
Department Name
Department of Dermatology Skin and Allergy
Principal Investigator Name
Laura Huilaja
Principal Investigator Email
Laura.huilaja@oulu.fi
Contact Person Name
Laura Huilaja
Contact Person Email
Laura.huilaja@oulu.fi

Spain

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
384
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Dermatologia
Principal Investigator Name
María del Mar Llamas Velasco
Principal Investigator Email
mar.llamasvelasco@gmail.com
Contact Person Name
María del Mar Llamas Velasco
Contact Person Email
mar.llamasvelasco@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Dermatologia
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
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Dermatologia
Principal Investigator Name
Juan Francisco Silvestre Salvador
Principal Investigator Email
silvestre_jfr@gva.es
Contact Person Name
Juan Francisco Silvestre Salvador
Contact Person Email
silvestre_jfr@gva.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Dermatologia
Principal Investigator Name
Esther Serra Baldrich
Principal Investigator Email
eserra@santpau.cat
Contact Person Name
Esther Serra Baldrich
Contact Person Email
eserra@santpau.cat
Site Name
Hospital Universitario La Paz
Department Name
Dermatologia
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 Germans Trias I Pujol
Department Name
Dermatologia
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
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Dermatologia
Principal Investigator Name
Alicia Gonzalez Quesada
Principal Investigator Email
ali_gq@hotmail.com
Contact Person Name
Alicia Gonzalez Quesada
Contact Person Email
ali_gq@hotmail.com
Site Name
Hospital Universitario Miguel Servet
Department Name
Dermatologia
Principal Investigator Name
Fermina Yolanda Gilaberte Calzada
Principal Investigator Email
ygilaberte@gmail.com
Contact Person Name
Fermina Yolanda Gilaberte Calzada
Contact Person Email
ygilaberte@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau (duplicate site listing consolidated)
Department Name
Dermatologia

Hungary

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
420
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Beata Bakos
Principal Investigator Email
beata.bakos@oec.hu
Contact Person Name
Beata Bakos
Contact Person Email
beata.bakos@oec.hu
Site Name
University Of Pecs
Department Name
Bor-, Nemikortani es Onkodermatologiai 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
Borgyogyaszati es Allergologiai Klinika
Principal Investigator Name
Nora Belso
Principal Investigator Email
belso.nora@med.u-szeged.hu
Contact Person Name
Nora Belso
Contact Person Email
belso.nora@med.u-szeged.hu
Site Name
Derm-Surg Kft.
Principal Investigator Name
Beata Fabos
Principal Investigator Email
fabosbeata@gmail.com
Contact Person Name
Beata Fabos
Contact Person Email
fabosbeata@gmail.com
Site Name
University Of Debrecen
Department Name
Borgyogyaszati Klinika
Principal Investigator Name
Andrea Szegedi
Principal Investigator Email
aszegedi@med.unideb.hu
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
DermaMed Research Kft.
Principal Investigator Name
Piroska Dosa
Principal Investigator Email
dosapiros@gmail.com
Contact Person Name
Piroska Dosa
Contact Person Email
dosapiros@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
09-08-2024
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
416
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Servico de Dermatologia
Principal Investigator Name
Ines Lobo
Principal Investigator Email
ineslobo7@gmail.com
Contact Person Name
Ines Lobo
Contact Person Email
ineslobo7@gmail.com
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Servico de Dermatologia
Principal Investigator Name
Pedro Mendes Bastos
Principal Investigator Email
pmendesbastos@gmail.com
Contact Person Name
Pedro Mendes Bastos
Contact Person Email
pmendesbastos@gmail.com
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Servico de Dermatologia
Principal Investigator Name
Joana Antunes
Principal Investigator Email
joanaferroantunes@gmail.com
Contact Person Name
Joana Antunes
Contact Person Email
joanaferroantunes@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
387
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.
Principal Investigator Name
Jacek Szepietowski
Principal Investigator Email
cityclinic.matusiak@gmail.com
Contact Person Name
Jacek Szepietowski
Contact Person Email
cityclinic.matusiak@gmail.com
Site Name
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
Principal Investigator Name
Adam Wroński
Principal Investigator Email
bk@dermal.pl
Contact Person Name
Adam Wroński
Contact Person Email
bk@dermal.pl
Site Name
Amicare Sp. z o.o. S.K.
Principal Investigator Name
Aleksandra Bała-Wojsznis
Principal Investigator Email
a.bala-wojsznis@amicare.pl
Contact Person Name
Aleksandra Bała-Wojsznis
Contact Person Email
a.bala-wojsznis@amicare.pl
Site Name
Royalderm Agnieszka Nawrocka
Principal Investigator Name
Witold Owczarek
Principal Investigator Email
kontakt@royalderm.pl
Contact Person Name
Witold Owczarek
Contact Person Email
kontakt@royalderm.pl
Site Name
Dermedic Jacek Zdybski
Principal Investigator Name
Piotr Parcheta
Principal Investigator Email
piotr.parcheta@zdybski.pl
Contact Person Name
Piotr Parcheta
Contact Person Email
piotr.parcheta@zdybski.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Dermatology
Principal Investigator Name
Adam Reich
Principal Investigator Email
dermatologia@szpital.rzeszow.pl
Contact Person Name
Adam Reich
Site Name
Akk Medical Sp. z o.o.
Principal Investigator Name
Izabela Karamon
Principal Investigator Email
rejestracja@tusieleczy.pl
Contact Person Name
Izabela Karamon
Contact Person Email
rejestracja@tusieleczy.pl
Site Name
Dermmedica Sp. z o.o.
Principal Investigator Name
Jolanta Węgłowska
Principal Investigator Email
jolanta.weglowska@dermmedica.pl
Contact Person Name
Jolanta Węgłowska
Site Name
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Principal Investigator Name
Hubert Arasiewicz
Principal Investigator Email
badania-kliniczne@czdir.pl
Contact Person Name
Hubert Arasiewicz
Contact Person Email
badania-kliniczne@czdir.pl
Site Name
Gyncentrum Sp. z o.o.
Principal Investigator Name
Marcin Zakrzewski
Principal Investigator Email
m.zemelka@holsaclinical.com
Contact Person Name
Marcin Zakrzewski
Contact Person Email
m.zemelka@holsaclinical.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Dermatology
Principal Investigator Name
Roman Nowicki
Principal Investigator Email
dermatologia@gumed.edu.pl
Contact Person Name
Roman Nowicki
Contact Person Email
dermatologia@gumed.edu.pl
Site Name
Velocity Skierniewice Sp. z o.o.
Principal Investigator Name
Witold Urban
Principal Investigator Email
wurban@velocityclinical.com
Contact Person Name
Witold Urban
Contact Person Email
wurban@velocityclinical.com

Romania

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
402
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Dermatology
Principal Investigator Name
Sorina Danescu
Principal Investigator Email
secretariat@scjucluj.ro
Contact Person Name
Sorina Danescu
Contact Person Email
secretariat@scjucluj.ro
Site Name
Spitalul Clinic Judetean Mures
Department Name
Dermatology
Principal Investigator Name
Silviu-Horia Morariu
Principal Investigator Email
secretariat@spitaljudeteanmures.ro
Contact Person Name
Silviu-Horia Morariu

Germany

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
362
Number Of Sites
12
Number Of Participants
22

Sites

Site Name
Rosenpark Research GmbH
Department Name
Dermatologie
Principal Investigator Name
Oliver Weirich
Principal Investigator Email
info@rosenparkresearch.de
Contact Person Name
Oliver Weirich
Contact Person Email
info@rosenparkresearch.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Klinik für Dermatologie und Allergologie
Principal Investigator Name
Andreas Wollenberg
Principal Investigator Email
dermatologie@uk-augsburg.de
Contact Person Name
Andreas Wollenberg
Contact Person Email
dermatologie@uk-augsburg.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten - Zentrale Studienkoordination für innovative Dermatologie (ZiD)
Principal Investigator Name
Claudia Zeidler
Principal Investigator Email
zid@ukmuenster.de
Contact Person Name
Claudia Zeidler
Contact Person Email
zid@ukmuenster.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Sascha Gerdes
Principal Investigator Email
dermaambulanz@uksh.de
Contact Person Name
Sascha Gerdes
Contact Person Email
dermaambulanz@uksh.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Principal Investigator Name
Andrea Bauer
Principal Investigator Email
dermastudien@uniklinikum-dresden.de
Contact Person Name
Andrea Bauer
Site Name
Hautarztpraxis Dariusch Mortazawi
Department Name
Hautarztpraxis
Principal Investigator Name
Dariusch Mortazawi
Principal Investigator Email
mortazawi@gmx.de
Contact Person Name
Dariusch Mortazawi
Contact Person Email
mortazawi@gmx.de
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Klinik für Dermatologie
Principal Investigator Name
Galina Balakirski
Principal Investigator Email
Galina.Balakirski@helios-gesundheit.de
Contact Person Name
Galina Balakirski
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Institut für Allergieforschung
Principal Investigator Name
Martin Metz
Principal Investigator Email
hautsache-ifa@charite.de
Contact Person Name
Martin Metz
Contact Person Email
hautsache-ifa@charite.de
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Dermatologie
Principal Investigator Name
Anthanasios Tsianakas
Principal Investigator Email
studien-dermatologie@fk-bentheim.de
Contact Person Name
Anthanasios Tsianakas
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Hautklinik
Principal Investigator Name
Sebastian Volc
Principal Investigator Email
service@med.uni-tuebingen.de
Contact Person Name
Sebastian Volc
Contact Person Email
service@med.uni-tuebingen.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik und Poliklinik
Principal Investigator Name
Petra Staubach-Renz
Principal Investigator Email
crc-hautklinik@unimedizin-mainz.de
Contact Person Name
Petra Staubach-Renz
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (additional listing consolidated)

Italy

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
465
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOSD di Dermatologia
Principal Investigator Name
Luca Bianchi
Principal Investigator Email
luca.bianchi@uniroma2.it
Contact Person Name
Luca Bianchi
Contact Person Email
luca.bianchi@uniroma2.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di 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
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
ASST Fatebenefratelli Sacco
Department Name
Allergologia e Immunologia Clinica
Principal Investigator Name
Enrico Iemoli
Principal Investigator Email
enrico.iemoli@asst-fbf-sacco.it
Contact Person Name
Enrico Iemoli
Site Name
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Department Name
UOSD di Dermatologia Generale ed Oncologica
Principal Investigator Name
Maria Esposito
Principal Investigator Email
maria.esposito3@univaq.it
Contact Person Name
Maria Esposito
Contact Person Email
maria.esposito3@univaq.it

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Suvoda LLC
Responsibilities
Randomisation/IRT and related trial technology (sponsor duty code present)
Name
Icon Clinical Research Limited
Responsibilities
Ongoing review of subject mental health related data
Name
Excelya Greece CRO Single Member S.A.
Responsibilities
Monitoring submission activities
Name
WCG Clinical Inc.
Responsibilities
Investigator eCOA training and certification
Name
Reify Health Inc.
Responsibilities
Cloud-based pre-screening and enrollment management
Name
Bioclinica Inc.
Responsibilities
Cardiovascular event adjudication

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duty code 3 (role code provided in record)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"Sponsor duty code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Cardiovascular Event Adjudication","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Ongoing review of subject mental health related data","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator eCOA Training and certification","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Biomarker/sample analysis (listed sponsor duty code 4)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Cloud-based pre-screening and enrollment management","organisation_type":"Hospital/Clinic/Other health care facility (service provider)"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Management of body photography images for the optional sub study","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Laboratory Sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sponsor duty code 4 (biomarker/sample testing)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duty code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"Monitoring Submission Activities","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Rocatinlimab
Active Substance
ROCATINLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Investigational (used in clinical trial)
Investigational Product Name
Placebo for AMG 451
Modality
Other

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