Clinical trial • Phase III • Dermatology|Immunology

4-[3-(CYANOMETHYL)-3-(3',5'-DIMETHYL-1H,1'H-[4,4'-BIPYRAZOL]-1-YL)AZETIDIN-1-YL]-2,5-DIFLUORO-N-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZAMIDE for Prurigo nodularis

Phase III trial of 4-[3-(CYANOMETHYL)-3-(3',5'-DIMETHYL-1H,1'H-[4,4'-BIPYRAZOL]-1-YL)AZETIDIN-1-YL]-2,5-DIFLUORO-N-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZAM…

Overview

Trial Therapeutic Area
Dermatology|Immunology
Trial Disease
Prurigo nodularis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-08-2024
First CTIS Authorization Date
27-11-2024

Trial design

Randomised, povorcitinib dose 1 once daily (qd) for 24 weeks; povorcitinib dose 2 once daily (qd) for 24 weeks; placebo qd for 24 weeks-controlled Phase III trial in Netherlands, France, Germany and others.

Randomised
Yes
Comparator
Povorcitinib Dose 1 once daily (QD) for 24 weeks; Povorcitinib Dose 2 once daily (QD) for 24 weeks; Placebo QD for 24 weeks
Target Sample Size
330
Trial Duration For Participant
336

Eligibility

Recruits 330 Participants must have the ability to comprehend and be willing to sign a written informed consent form (ICF). The protocol notes country-specific restrictions: "The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code." Consent is obtained via a written ICF; participants are adults (≥18 years; ≥19 in South Korea) and must provide their own consent..

Pregnancy Exclusion
5. Pregnant (or are considering pregnancy) or breastfeeding.
Vulnerable Population
Participants must have the ability to comprehend and be willing to sign a written informed consent form (ICF). The protocol notes country-specific restrictions: "The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code." Consent is obtained via a written ICF; participants are adults (≥18 years; ≥19 in South Korea) and must provide their own consent.

Inclusion criteria

  • {"criterion_text":"- 1. Ability to comprehend and willingness to sign a written ICF for the study.\n- 2. 18 to 75 years of age. Note: For South Korea, 19 years of age or older.\n- 3. Clinical diagnosis of PN for at least 3 months before screening.\n- 4. Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1.\n- 5. ≥ 20 pruriginous lesions in total on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at screening and Day 1.\n- 6. IGA-CPG-S score ≥ 3 at screening and Day 1.\n- 7. Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment (eg, TCS or TCI) with the exception of treatment failure with prior topical or systemic JAK or TYK2 inhibitors (see Exclusion Criterion 10).\n- 8. Willingness to avoid pregnancy or fathering children based on the criteria detailed in section 5.1. of the protocol (under inclusion criteria 8).\n- 9. Willing and able to comply with the study protocol and procedures."}

Exclusion criteria

  • {"criterion_text":"- 1. Chronic pruritus due to a condition other than PN.\n- 18. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.\n- 19. Any condition, laboratory result, or result of screening assessments that would, in the investigator's and sponsor's (or designee's) judgment, interfere with full participation in the study, including administration of study drug and attending required study visits, pose a significant risk to the participant, or interfere with interpretation of study data.\n- 2. Neuropathic and psychogenic pruritus.\n- 20. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.\n- 3. Diagnosis of PN secondary to medications.\n- 4. Active AD lesions within 3 months of screening.\n- 5. Pregnant (or are considering pregnancy) or breastfeeding.\n- 6. Concurrent conditions or history of other diseases detailed in section 5.2. of the protocol (under exclusion criteria 6).\n- 7. A screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment (eg, acute myocardial infarction, serious tachyarrhythmias or bradyarrhythmias) or that is indicative of serious underlying heart disease (eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, Wolff Parkinson-White syndrome) or criteria associated with QT/QTcF abnormalities.\n- 8. Significant trauma or major surgery (per investigator's assessment) within 30 days prior to screening.\n- 10. History of treatment failure for PN or any other inflammatory condition.\n- 9. Planned or expected major surgery during the initial 24 weeks of treatment with study drug (ie, during the PC period of the study).\n- 13. Receipt of medical treatment or investigational drugs within intervals specified in section 5.2 of the protocol (under exclusion criteria 13)\n- 11. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months prior to screening.\n- 12. Initiation or changing the dose of any of the treatments listed in section 5.2. of the protocol (under exclusion criteria 12) within 3 months of Day 1 or expected dose change of any of the following treatments during the initial 24 weeks of treatment with study drug (ie, during the PC period).\n- 14. Concurrent enrollment in another clinical study.\n- 15. At the screening visit, any of the laboratory abnormalities defined in Table 6 of the protocol.\n- 16. Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2.\n- 17. Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3).\n- 20. Evidence of HBV or HCV infection or risk of reactivation (see Section 8.3.5.4)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants achieving Itch NRS4 (≥ 4-point improvement [reduction] in Itch NRS score from baseline) and IGA-CPG-S-TS (IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline) at Week 24","definition_or_measurement_approach":"Itch NRS4 defined as ≥4-point improvement (reduction) in Itch NRS score from baseline; IGA-CPG-S-TS defined as IGA CPG-S score of 0 or 1 with a ≥2-grade improvement from baseline. Measured at Week 24."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of participants achieving Itch NRS4 at Week 24","definition_or_measurement_approach":"Itch NRS4 defined as ≥4-point improvement (reduction) in Itch NRS score from baseline; measured at Week 24."}
  • {"endpoint_text":"- Proportion of participants achieving IGA CPG S-TS at Week 24","definition_or_measurement_approach":"IGA CPG S-TS defined as IGA CPG-S score of 0 or 1 with a ≥2-grade improvement from baseline; measured at Week 24."}
  • {"endpoint_text":"- Proportion of participants achieving Itch NRS4 at Week 4","definition_or_measurement_approach":"Itch NRS4 defined as ≥4-point improvement (reduction) in Itch NRS score from baseline; measured at Week 4."}

Recruitment

Digital Remote Recruitment
True, digital methods described include online pre-screening scripts/prescreener questionnaires, banner ads, patient website content, social media (Instagram) and online pre-screening handled by Galen Patient Recruitment (documents: K2 and K1 recruitment materials; e.g., 'K2_GALEN PN Online PreScreener', 'K2_Recruitment material_Galen_Online Pre-Screening Script').
Planned Sample Size
330
Recruitment Window Months
33
Consent Approach
Written informed consent: participants must be able to comprehend and sign a written ICF. Only adults are eligible (18–75 years; 19+ in South Korea). Multiple language ICFs and subject information documents are provided (documents available in English and multiple local languages per country: English, French, German, Polish, Dutch, Bulgarian, Italian, etc.). Country-specific restrictions apply (for example, France excludes certain vulnerable populations and adults under legal protection as noted in exclusion criteria).

Methods

  • Online pre-screening (Galen Patient Recruitment: 'K2_Recruitment material_Galen_Online Pre-Screening Script' / 'K2_PN_Online_PreScreener' documents) — digital prescreener targeting potential PN participants
  • Banner advertisements (online) — 'K2_PN_BannerAds' / 'K2_Recruitment material_Galen_Banner Ads' documents
  • Patient-facing website information pages (Patient Website) — 'K2_PN_Patient Website' / 'Galen_Patient Website' documents
  • Prescreener tools/forms (digital prescreener questionnaires) — 'K2_Recruitment material Prescreener' / 'K2_PN_Online_PreScreener' documents
  • Social media post (Instagram) — 'K2_Recruitment material_Instagram post' (country-specific use documented for some MS)
  • Local site recruitment (hospital/clinic sites listed per country) — site-based screening and referral

Geography

Total Number Of Sites
66
Total Number Of Participants
162

Netherlands

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
11
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Stichting Amsterdam UMC
Department Name
Department of Dermatology/Netherlands Institute for Pigment Disorders
Principal Investigator Name
Phyllis Spuls
Principal Investigator Email
poli.dermatologie@amc.nl
Contact Person Name
Phyllis Spuls
Contact Person Email
poli.dermatologie@amc.nl
Site Name
Maxima Medisch Centrum
Department Name
Department of Dermatology
Principal Investigator Name
Jorn Bovenschen
Principal Investigator Email
info@mmc.nl
Contact Person Name
Jorn Bovenschen
Contact Person Email
info@mmc.nl

France

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
28-11-2024
Processing Time Days
6
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Du Docteur Ruer S.E.L.A.R.L.
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 Universitaire De Toulouse
Department Name
Service de Dermatologie
Principal Investigator Name
Maella Severino-Freire
Principal Investigator Email
severino-freire.m@chu-toulouse.fr
Contact Person Name
Maella Severino-Freire
Site Name
Hopital Prive D Antony
Department Name
Service de Dermatologie
Principal Investigator Name
Pierre-André Becherel
Principal Investigator Email
P.BECHEREL@ramsaygds.fr
Contact Person Name
Pierre-André Becherel
Contact Person Email
P.BECHEREL@ramsaygds.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service de Dermatologie
Principal Investigator Name
Catherine Michel
Principal Investigator Email
MICHELC@ghrmsa.fr
Contact Person Name
Catherine Michel
Contact Person Email
MICHELC@ghrmsa.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service de Dermatologie
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
Hopitaux Drome Nord
Department Name
Service de Dermatologie
Principal Investigator Name
François Skowron
Principal Investigator Email
f.skowron@hopitaux-drome-nord.fr
Contact Person Name
François Skowron
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Dermatologie
Principal Investigator Name
Sébastien Barbarot
Principal Investigator Email
sebastien.barbarot@chu-nantes.fr
Contact Person Name
Sébastien Barbarot
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Dermatologie
Principal Investigator Name
Jean-David Bouaziz
Principal Investigator Email
jean-david.bouaziz@aphp.fr
Contact Person Name
Jean-David Bouaziz
Contact Person Email
jean-david.bouaziz@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse (duplicate listing in file)
Department Name
Service de Dermatologie
Principal Investigator Name
Maella Severino-Freire
Principal Investigator Email
severino-freire.m@chu-toulouse.fr
Contact Person Name
Maella Severino-Freire

Germany

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
27-11-2024
Processing Time Days
40
Number Of Sites
13
Number Of Participants
46

Sites

Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Dermatologie und Venerologie
Principal Investigator Name
Johannes WOHLRAB
Principal Investigator Email
johannes.wohlrab@medizin.uni-halle.de
Contact Person Name
Johannes WOHLRAB
Site Name
Universitaet Leipzig
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Jan C. SIMON
Principal Investigator Email
jan.simon@medizin.uni-leipzig.de
Contact Person Name
Jan C. SIMON
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Institute of Allergology
Principal Investigator Name
Martin METZ
Principal Investigator Email
martin.metz@charite.de
Contact Person Name
Martin METZ
Contact Person Email
martin.metz@charite.de
Site Name
Hautzentrum Friedrichshain-Studien
Department Name
Dermatologie
Principal Investigator Name
Jens ROSSBACHER
Principal Investigator Email
rossbacher@hzfh.de
Contact Person Name
Jens ROSSBACHER
Contact Person Email
rossbacher@hzfh.de
Site Name
Philipps-Universitaet Marburg
Department Name
Department of Dermatology and Allergology
Principal Investigator Name
Michael Hertl
Principal Investigator Email
hertl@med.uni-marburg.de
Contact Person Name
Michael Hertl
Contact Person Email
hertl@med.uni-marburg.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Institut für Entzündungsmedizin
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
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Fachabteilung 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
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Hautklinik und Poliklinik
Principal Investigator Name
Petra STAUBACH-RENZ
Principal Investigator Email
petra.staubach@unimedizin-mainz.de
Contact Person Name
Petra STAUBACH-RENZ
Site Name
Klinikum Dortmund gGmbH
Department Name
Hautklinik
Principal Investigator Name
Laura SUSOK
Principal Investigator Email
Laura.susok@klinikumdo.de
Contact Person Name
Laura SUSOK
Contact Person Email
Laura.susok@klinikumdo.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitäts-Hautklinik Studienzentrum Immundermatologie
Principal Investigator Name
Sebastian P. VOLC
Principal Investigator Email
sebastian.volc@med.uni-tuebingen.de
Contact Person Name
Sebastian P. VOLC
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Competenzzentrum Dermatologische Forschung
Principal Investigator Name
Matthias AUGUSTIN
Principal Investigator Email
augustin@cedef.de
Contact Person Name
Matthias AUGUSTIN
Contact Person Email
augustin@cedef.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department of Dermatology
Principal Investigator Name
Elke WEISSHAAR
Principal Investigator Email
elke.weisshaar@med.uni-heidelberg.de
Contact Person Name
Elke WEISSHAAR
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Dermatologie und Allergologie
Principal Investigator Name
Joerg Wenzel
Principal Investigator Email
Joerg.Wenzel@ukbonn.de
Contact Person Name
Joerg Wenzel
Contact Person Email
Joerg.Wenzel@ukbonn.de

Italy

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
27-11-2024
Processing Time Days
6
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Ospedale Santa Chiara - U.O. Dermatologia
Principal Investigator Name
Marco Romanelli
Principal Investigator Email
marco.romanelli@unipi.it
Contact Person Name
Marco Romanelli
Contact Person Email
marco.romanelli@unipi.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
S.C. di Dermatologia, Piazzale Giorgio Menghini, 3, 06129, Perugia, Italy
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 Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Dipartimento di Salute Mentale e Fisica e Medicina Preventiva – UOC 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
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Department Name
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco – U.O. Dermatologia
Principal Investigator Name
Giuseppe Micali
Principal Investigator Email
giuseppe.micali@unict.it
Contact Person Name
Giuseppe Micali
Contact Person Email
giuseppe.micali@unict.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Humanitas Research Hospital - U.O. Dermatologia
Principal Investigator Name
Antonio Costanzo
Principal Investigator Email
antonio.costanzo@hunimed.eu
Contact Person Name
Antonio Costanzo
Contact Person Email
antonio.costanzo@hunimed.eu
Site Name
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Department Name
Ospedale Regionale San Salvatore - UOSD Dermatologia Generale ed Oncologica DU
Principal Investigator Name
Maria Esposito
Principal Investigator Email
maria.esposito3@univaq.it
Contact Person Name
Maria Esposito
Contact Person Email
maria.esposito3@univaq.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Center for Advanced Studies and Technology - Clinical Research Center
Principal Investigator Name
Paolo Amerio
Principal Investigator Email
paolo.amerio@unich.it
Contact Person Name
Paolo Amerio
Contact Person Email
paolo.amerio@unich.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC Dermatologia Via Pace 9, 20122, Milan
Principal Investigator Name
Silvia Mariel Ferrucci
Principal Investigator Email
siliva.ferrucci@policlinico.mi.it
Contact Person Name
Silvia Mariel Ferrucci
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Dermatologia
Principal Investigator Name
Ketty Peris
Principal Investigator Email
ketty.peris@unicatt.it
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda Ospedaliero Universitaria Pisana (duplicate listing)
Department Name
Ospedale Santa Chiara - U.O. Dermatologia
Principal Investigator Name
Marco Romanelli
Principal Investigator Email
marco.romanelli@unipi.it
Contact Person Name
Marco Romanelli
Contact Person Email
marco.romanelli@unipi.it

Poland

Earliest CTIS Part Ii Submission Date
13-12-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
-1
Number Of Sites
22
Number Of Participants
44

Sites

Site Name
Evimed Sp. z o.o.
Department Name
Centrum Medyczne Evimed
Principal Investigator Name
Monika Slowinska
Principal Investigator Email
monika.slowinska@yahoo.com
Contact Person Name
Monika Slowinska
Contact Person Email
monika.slowinska@yahoo.com
Site Name
Diamond Clinic Sp. z o.o. (Cracow - U11)
Department Name
Diamond Medical Center
Principal Investigator Name
Barbara Rewerska
Principal Investigator Email
biuro@diamondclinic.eu
Contact Person Name
Barbara Rewerska
Contact Person Email
biuro@diamondclinic.eu
Site Name
Diamond Clinic Sp. z o.o. (Cracow - U14)
Department Name
Diamond Medical Center
Principal Investigator Name
Barbara Rewerska
Principal Investigator Email
biuro@diamondclinic.eu
Contact Person Name
Barbara Rewerska
Contact Person Email
biuro@diamondclinic.eu
Site Name
Pro Familia Altera Sp. z o.o.
Department Name
Pro Familia Altera Poradnia Wielospecjalistyczna
Principal Investigator Name
Ewa Sygula
Principal Investigator Email
esyg@wp.pl
Contact Person Name
Ewa Sygula
Contact Person Email
esyg@wp.pl
Site Name
Laser clinic S C Andrzej Krolicki Tomasz Kochanowski
Principal Investigator Name
Katarzyna Turek-Urasinska
Principal Investigator Email
katarzyna.urasinska@wp.pl
Contact Person Name
Katarzyna Turek-Urasinska
Contact Person Email
katarzyna.urasinska@wp.pl

Bulgaria

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
10
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Medical Center Medconsult Pleven OOD
Principal Investigator Name
Krasimira Vasileva
Principal Investigator Email
vasileva_mclovech@abv.bg
Contact Person Name
Krasimira Vasileva
Contact Person Email
vasileva_mclovech@abv.bg
Site Name
Medical Center Medconsult Pleven OOD (Pleven address)
Principal Investigator Name
Kamelia Vekovska
Principal Investigator Email
kvekovska_medconsult@abv.bg
Contact Person Name
Kamelia Vekovska
Contact Person Email
kvekovska_medconsult@abv.bg
Site Name
Medical Center Prolet EOOD
Principal Investigator Name
Zoya Boyanova
Principal Investigator Email
med.center.prolet@gmail.com
Contact Person Name
Zoya Boyanova
Contact Person Email
med.center.prolet@gmail.com
Site Name
UNIMED Medical Center EOOD
Principal Investigator Name
Marina Sankeva
Principal Investigator Email
dr_sankeva@abv.bg
Contact Person Name
Marina Sankeva
Contact Person Email
dr_sankeva@abv.bg
Site Name
Diagnostic Consultative Centre Ascendent EOOD
Principal Investigator Name
Nadya Tosheva
Principal Investigator Email
nadya.tosheva@futuremeds.bg
Contact Person Name
Nadya Tosheva
Contact Person Email
nadya.tosheva@futuremeds.bg

Austria

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
02-12-2024
Processing Time Days
27
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Klinik Hietzing
Department Name
Wiener Krankenanstaltenverbund, Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel
Principal Investigator Name
PAUL-GUNTHER SATOR
Principal Investigator Email
paul.sator@gesundheitsverbund.at
Contact Person Name
PAUL-GUNTHER SATOR
Site Name
Medical University Of Graz
Department Name
Medical University of Graz, Dpt. Dermatology and Venerology
Principal Investigator Name
Franz J. LEGAT
Principal Investigator Email
franz.legat@medunigraz.at
Contact Person Name
Franz J. LEGAT
Contact Person Email
franz.legat@medunigraz.at

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple operational roles listed (codes present) and 'Concierge service' as provided in sponsor third-party duties
Name
IQVIA Limited
Responsibilities
Cardiovascular events adjudication

Third parties

  • {"country":"United States","full_name":"Galen Patient Recruitment Inc.","duties_or_roles":"Recruitment activities","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Study supplies like wood lamps, incubators, freezers","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Incyte Corp.","duties_or_roles":"Serum Biomarker and PK","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"packaging, labeling and batch release","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Cardiovascular events adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple roles including concierge service (sponsorDuties include codes and 'Concierge service')","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Povorcitinib
Active Substance
4-[3-(CYANOMETHYL)-3-(3',5'-DIMETHYL-1H,1'H-[4,4'-BIPYRAZOL]-1-YL)AZETIDIN-1-YL]-2,5-DIFLUORO-N-[(2S)-1,1,1-TRIFLUOROPROPAN-2-YL]BENZAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Frequency
QD
Investigational Product Name
Placebo to Povorcitinib
Modality
Other
Frequency
QD

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