Clinical trial • Phase III • Dermatology
POVORCITINIB for Vitiligo
Phase III trial of POVORCITINIB for Vitiligo.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Vitiligo
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-11-2023
- First CTIS Authorization Date
- 26-03-2024
Trial design
Randomised, open-label, placebo to povorcitinib (placebo) — no dose or schedule specified in the ctis record.-controlled Phase III trial in Italy, Hungary, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Placebo to Povorcitinib (Placebo) — no dose or schedule specified in the CTIS record.
- Target Sample Size
- 444
- Trial Duration For Participant
- 728
Eligibility
Recruits 444 Vulnerable populations are specifically addressed: participants must be able to comprehend and sign a written informed consent form (ICF). The protocol excludes vulnerable populations in France per article L.1121-6 of the French Public Health Code, adults under legal protection, or individuals unable to express consent (article L.1121-8) or not affiliated to social security (L.1121-8-1). Consent/assent handling: only adults ≥18 may consent; written ICFs and country-specific ICF documents (including optional photography consent and pregnant-partner materials) are used..
- Pregnancy Exclusion
- 8. Women who are pregnant, considering pregnancy, or breastfeeding.
- Vulnerable Population
- Vulnerable populations are specifically addressed: participants must be able to comprehend and sign a written informed consent form (ICF). The protocol excludes vulnerable populations in France per article L.1121-6 of the French Public Health Code, adults under legal protection, or individuals unable to express consent (article L.1121-8) or not affiliated to social security (L.1121-8-1). Consent/assent handling: only adults ≥18 may consent; written ICFs and country-specific ICF documents (including optional photography consent and pregnant-partner materials) are used.
Inclusion criteria
- {"criterion_text":"- 1. Ability to comprehend and willingness to sign a written ICF for the study.\n- 2. Aged ≥ 18 years at the time of consent.\n- 3. Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol\n- 4. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.\n- 5. Willingness to avoid pregnancy or fathering children based on the criteria listed in the section 5.1.5 of the protocol.\n- 6. Willing and able to comply with the study Protocol and procedures, including photography."}
Exclusion criteria
- {"criterion_text":"- 1. Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).\n- 6. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.\n- 7. Spontaneous and significant repigmentation within 6 months prior to screening (eg, repigmentation without any treatment and significant in amount as determined by the investigator).\n- 10. A screening 12-lead electrocardiogram (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 QT interval corrected (QTc) > 480 milliseconds (> 470 milliseconds in the UK only) at screening.\n- 8. Women who are pregnant, considering pregnancy, or breastfeeding.\n- 9. Concurrent conditions or history of other diseases, as listed in section 5.2.9 of the protocol\n- 22. The following participants are excluded in the EU: participants with increased risks of events associated with JAK inhibitors (specifically increased risk of major cardiovascular events [eg, > 65 years of age and current or past longtime smokers] and venous thromboembolism) unless the benefit/risk profile is still favorable in the opinion of the investigator.\n- 11. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.\n- 12. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.\n- 13. History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or any other inflammatory condition.\n- 14. Receipt of medical treatment or investigational drugs within the following interval prior to Day 1 (as outlined in section 5.2.14 of the protocol)\n- 18. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or risk of reactivation (see Section 8.3.5.4 of the protocol).\n- 15. At the screening visit, any of the laboratory abnormalities defined in Table 10 of the protocol\n- 16. Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2. of the protocol\n- 17. Active human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome. Active HIV is defined as a confirmed positive anti-HIV antibody test (see Section 8.3.5.3 of the protocol).\n- 23. Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions or leukotrichia in more than 33% of the total body (including the face) surface area affected with vitiligo lesions as assessed at screening.\n- 24. Had ≥ 3 laser hair removal treatments of an area to be treated for vitiligo.\n- 25. Concurrent enrollment in another clinical study.\n- 19. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.\n- 2. Clinically significant abnormal thyroid-stimulating hormone (TSH) or free thyroxine (T4) at screening as determined by the investigator.\n- 20. 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- 21. 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. Use of laser or light-based treatment (phototherapy), including tanning beds, within 8 weeks prior to Day 1.\n- 4. Use of dihydroxyacetone (generally present in self-tanning products) within 4 weeks prior to Day 1.\n- 5. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (monobenzone)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving ≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI75) at Week 52.","definition_or_measurement_approach":"Proportion of participants achieving ≥75% improvement from baseline in the Face Vitiligo Area Scoring Index (F-VASI) measured at Week 52 compared with baseline (F-VASI75)."}
Secondary endpoints
- {"endpoint_text":"- Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 52.","definition_or_measurement_approach":"Percent change in Total Body Vitiligo Area Scoring Index (T-VASI) from baseline to Week 52."}
- {"endpoint_text":"- Proportion of participants achieving ≥ 50% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI50) at Week 52","definition_or_measurement_approach":"Proportion of participants with ≥50% improvement in T-VASI from baseline at Week 52 (T-VASI50)."}
- {"endpoint_text":"- Proportion of participants achieving ≥ 75% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI75) at Week 52","definition_or_measurement_approach":"Proportion of participants with ≥75% improvement in T-VASI from baseline at Week 52 (T-VASI75)."}
- {"endpoint_text":"- Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of \"4 – A lot less noticeable\" or \"5 – No longer noticeable\" at Week 52.","definition_or_measurement_approach":"Proportion of participants reporting a Vitiligo Noticeability Scale (VNS) score of 4 or 5 at Week 52 (participant-perceived noticeability)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 444
- Recruitment Window Months
- 39
- Consent Approach
- Written informed consent required from each participant (must be able to comprehend and sign a written ICF). Multiple country- and language-specific ICF and subject information documents are included (English, Bulgarian, French, Polish, Hungarian versions present). Optional photography consent forms and a pregnant-partner information/consent form are provided. Electronic consent/payment tools (Greenphire references) and e-documentation are included in submitted materials.
Methods
- Recruitment activities in USA and Canada conducted by Galen Patient Recruitment Inc. (documented in third-party duties).
- Site-based recruitment via the listed participating dermatology clinics and hospitals in each Member State (documents include K1 recruitment arrangement files per country).
- Digital and multimedia materials: recruitment videos and animations (ENG, BGN), 'Thinking about joining' brochures and STOPv recruitment animations (documents present in CTIS documentation).
- Use of e-tools and eMaterials described in submitted documents (eDosing diary, ClinCard web screenshots, 3D Secure terms for payments).
Geography
- Total Number Of Sites
- 42
- Total Number Of Participants
- 281
Italy
- Earliest CTIS Part Ii Submission Date
- 25-01-2024
- Latest Decision Or Authorization Date
- 11-04-2025
- Processing Time Days
- 442
- Number Of Sites
- 5
- Number Of Participants
- 39
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Piergiacomo Calzavara Pinton
- Principal Investigator Email
- piergiacomo.calzavarapinton@unibs.it
- Contact Person Name
- Piergiacomo Calzavara Pinton
- Contact Person Email
- piergiacomo.calzavarapinton@unibs.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Antonio Costanzo
- Principal Investigator Email
- antonio.costanzo@hunimed.edu
- Contact Person Name
- Antonio Costanzo
- Contact Person Email
- antonio.costanzo@hunimed.edu
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Dermatology Unit
- 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
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Angelo Valerio Marzano
- Principal Investigator Email
- angelo.marzano@unimi.it
- Contact Person Name
- Angelo Valerio Marzano
- Contact Person Email
- angelo.marzano@unimi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Dermatology Unit
- Principal Investigator Name
- Ketty Peris
- Principal Investigator Email
- ketty.peris@unicatt.it
- Contact Person Name
- Ketty Peris
- Contact Person Email
- ketty.peris@unicatt.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-02-2024
- Latest Decision Or Authorization Date
- 24-04-2025
- Processing Time Days
- 434
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- University Of Debrecen
- Department Name
- Bőrgyógyászati 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
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
- Department Name
- Bőrgyógyászati Osztály
- Principal Investigator Name
- Enikő Mojzesné Telegdy
- Principal Investigator Email
- telegdyeniko@yahoo.com
- Contact Person Name
- Enikő Mojzesné Telegdy
- Contact Person Email
- telegdyeniko@yahoo.com
- Site Name
- Orvostudomanyi Kutato es Fejleszto Kft.
- Principal Investigator Name
- Tamás Almádi
- Principal Investigator Email
- almadi.tamas@gmail.hu
- Contact Person Name
- Tamás Almádi
- Contact Person Email
- almadi.tamas@gmail.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 22-04-2025
- Processing Time Days
- 421
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Kamran Ghoreschi
- Principal Investigator Email
- Kamran.ghoreschi@charite.de
- Contact Person Name
- Kamran Ghoreschi
- Contact Person Email
- Kamran.ghoreschi@charite.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
- Technische Universitat Dresden
- Department Name
- Klinik und Poliklinik für Dermatologie
- Principal Investigator Name
- Roland Aschoff
- Principal Investigator Email
- roland.aschoff@ukdd.de
- Contact Person Name
- Roland Aschoff
- Contact Person Email
- roland.aschoff@ukdd.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- 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
- Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
- Principal Investigator Name
- Michael Sebastian
- Principal Investigator Email
- dr.sebastian@hautarztpraxis-mahlow.de
- Contact Person Name
- Michael Sebastian
- Contact Person Email
- dr.sebastian@hautarztpraxis-mahlow.de
- Site Name
- Universitaet Muenster
- Department Name
- UKM, Klinik für ZID
- Principal Investigator Name
- Nina Magnolo
- Principal Investigator Email
- Nina.Magnolo@ukmuenster.de
- Contact Person Name
- Nina Magnolo
- Contact Person Email
- Nina.Magnolo@ukmuenster.de
France
- Earliest CTIS Part Ii Submission Date
- 17-01-2024
- Latest Decision Or Authorization Date
- 21-02-2025
- Processing Time Days
- 401
- Number Of Sites
- 5
- Number Of Participants
- 37
Sites
- Site Name
- CHU De Rouen
- Department Name
- Clinique Dermatologique
- Principal Investigator Name
- Anne Benedicte Duval-Modeste
- Principal Investigator Email
- ab.duval-modeste@chu-rouen.fr
- Contact Person Name
- Anne Benedicte Duval-Modeste
- Contact Person Email
- ab.duval-modeste@chu-rouen.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
- 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 Le Mans
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Nathalie Beneton
- Principal Investigator Email
- nbeneton@ch-lemans.fr
- Contact Person Name
- Nathalie Beneton
- Contact Person Email
- nbeneton@ch-lemans.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Dermatologie
- Principal Investigator Name
- Thierry Passeron
- Principal Investigator Email
- passeron@unice.fr
- Contact Person Name
- Thierry Passeron
- Contact Person Email
- passeron@unice.fr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 02-06-2025
- Processing Time Days
- 439
- Number Of Sites
- 5
- Number Of Participants
- 23
Sites
- 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
- Asclepius Medical Center OOD
- Principal Investigator Name
- Boyka Stoyanova
- Principal Investigator Email
- krum.bonev@gmail.com
- Contact Person Name
- Boyka Stoyanova
- Contact Person Email
- krum.bonev@gmail.com
- Site Name
- Diagnostic And Consulting Center XXVIII-Sofia EOOD
- Principal Investigator Name
- Katya Zaharieva
- Principal Investigator Email
- r.ljubenova@rdservices.org
- Contact Person Name
- Katya Zaharieva
- Contact Person Email
- r.ljubenova@rdservices.org
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- 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
- Principal Investigator Name
- Ivan Botev
- Principal Investigator Email
- botev2@yahoo.com
- Contact Person Name
- Ivan Botev
- Contact Person Email
- botev2@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 20-03-2024
- Latest Decision Or Authorization Date
- 30-05-2025
- Processing Time Days
- 436
- Number Of Sites
- 18
- Number Of Participants
- 128
Sites
- Site Name
- PRYWATNY GABINET DERMATOLOGICZNY ELŻBIETA KŁUJSZO
- Principal Investigator Name
- Elżbieta Kłujszo
- Principal Investigator Email
- klujszoe@gmail.com
- Contact Person Name
- Elżbieta Kłujszo
- Contact Person Email
- klujszoe@gmail.com
- 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
- Synexus Polska Sp. z o.o. (Gdansk)
- Department Name
- Synexus Polska Sp. z o.o. Oddział w Gdańsku
- Principal Investigator Name
- Karolina Osiecka
- Principal Investigator Email
- karolina.osiecka@globalaes.com
- Contact Person Name
- Karolina Osiecka
- Contact Person Email
- karolina.osiecka@globalaes.com
- Site Name
- LASER CLINIC s.c. dr T. Kochanowski dr A. Królicki
- Principal Investigator Name
- Katarzyna Turek-Urasińśka
- Principal Investigator Email
- katarzyna.urasinska@wp.pl
- Contact Person Name
- Katarzyna Turek-Urasińśka
- Contact Person Email
- katarzyna.urasinska@wp.pl
- Site Name
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.
- Department Name
- "ALERGO-MED" AMBULATORYJNE ŚWIADCZENIA ZDROWOTNE
- Principal Investigator Name
- Bernadetta Majorek-Olechowska
- Principal Investigator Email
- bernadettaolechowska@gmail.com
- Contact Person Name
- Bernadetta Majorek-Olechowska
- Contact Person Email
- bernadettaolechowska@gmail.com
- Site Name
- Klinika Ambroziak Sp. z o.o.
- Department Name
- Klinika Ambroziak Dermatologia
- Principal Investigator Name
- Bartłomiej Kwiek
- Principal Investigator Email
- principal@klinikaambroziak.pl
- Contact Person Name
- Bartłomiej Kwiek
- Contact Person Email
- principal@klinikaambroziak.pl
- Site Name
- Synexus Polska Sp. z o.o. (Gdynia)
- Department Name
- "SYNEXUS POLSKA" ... ODDZIAŁ W GDYNI
- Principal Investigator Name
- Aneta Drożdżewska
- Principal Investigator Email
- aneta.drozdzewska@globalaes.com
- Contact Person Name
- Aneta Drożdżewska
- Contact Person Email
- aneta.drozdzewska@globalaes.com
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- TWOJA PRZYCHODNIA SCM Poradnia dermatologiczna
- Principal Investigator Name
- Tadeusz Dębniak
- Principal Investigator Email
- debniak@twojaprzychodnia.com
- Contact Person Name
- Tadeusz Dębniak
- Contact Person Email
- debniak@twojaprzychodnia.com
- Site Name
- Dermmedica Sp. z o.o.
- Department Name
- Centrum Columbus
- Principal Investigator Name
- Jolanta Węgłowska
- Principal Investigator Email
- jolanta.weglowska@dermmedica.pl
- Contact Person Name
- Jolanta Węgłowska
- Contact Person Email
- jolanta.weglowska@dermmedica.pl
- Site Name
- Futuremeds Sp. z o.o.
- Department Name
- Futuremeds Targówek
- Principal Investigator Name
- Agnieszka Jurek-Urbanowska
- Principal Investigator Email
- agnieszka.urbanowska@futuremeds.com
- Contact Person Name
- Agnieszka Jurek-Urbanowska
- Contact Person Email
- agnieszka.urbanowska@futuremeds.com
- Site Name
- Evimed Sp. z o.o.
- Department Name
- Centrum Medyczne Evimed
- Principal Investigator Name
- Monika Słowińska
- Principal Investigator Email
- monika.slowinska@yahoo.com
- Contact Person Name
- Monika Słowińska
- Contact Person Email
- monika.slowinska@yahoo.com
- Site Name
- Dermed Centrum Medyczne Sp. z o.o.
- Department Name
- Niepubliczny Zakład Opieki Zdrowotnej "DERMED" Centrum Medyczne
- Principal Investigator Name
- Aleksandra Kaszuba
- Principal Investigator Email
- akaszuba@op.pl
- Contact Person Name
- Aleksandra Kaszuba
- Contact Person Email
- akaszuba@op.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Joanna Maj
- Principal Investigator Email
- joanna.maj@cmoporow.com
- Contact Person Name
- Joanna Maj
- Contact Person Email
- joanna.maj@cmoporow.com
- Site Name
- Synexus Polska Sp. z o.o. (Wroclaw)
- Department Name
- "SYNEXUS POLSKA" ... ODDZIAŁ WE WROCŁAWIU
- Principal Investigator Name
- Tomasz Kołodziej
- Principal Investigator Email
- tomasz.kolodziej@globalaes.com
- Contact Person Name
- Tomasz Kołodziej
- Contact Person Email
- tomasz.kolodziej@globalaes.com
- Site Name
- Provita Sp. z o.o.
- Department Name
- Centrum Medyczne Angelius Provita
- Principal Investigator Name
- Anita Lewartowska-Bialek
- Principal Investigator Email
- m.kolanko@angelius.org
- Contact Person Name
- Anita Lewartowska-Bialek
- Contact Person Email
- m.kolanko@angelius.org
- Site Name
- Clinmedica Research Sp. z o.o.
- Department Name
- Clinmedica Research
- Principal Investigator Name
- Witold Urban
- Principal Investigator Email
- w.urban@etg-network.com
- Contact Person Name
- Witold Urban
- Contact Person Email
- w.urban@etg-network.com
- Site Name
- Dermoklinika-Centrum Medyczne s.c., M. Kierstan, J. Narbutt, A. Lesiak
- Department Name
- DERMOKLINIKA DERMATOLOGIA KLINICZNA I ESTETYCZNA
- 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
- Pro Familia Altera Sp. z o.o.
- Department Name
- PRO FAMILIA ALTERA PORADNIA WIELOSPECJALISTYCZNA
- Principal Investigator Name
- Ewa Syguła
- Principal Investigator Email
- esyg@wp.pl
- Contact Person Name
- Ewa Syguła
- Contact Person Email
- esyg@wp.pl
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
- sponsorDuties codes:1,12,13,15 ('subjects reimbursement'),2,4,5,6 (as listed in CTIS third-party duties)
- Name
- IQVIA Limited
- Responsibilities
- Cardiovascular events adjudication
- Name
- Suvoda LLC
- Responsibilities
- sponsorDuties code:3 (as listed)
Third parties
- {"country":"United States","full_name":"Incyte Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-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":"Olink Proteomics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Kintetsu World Express (Benelux) B.V.","duties_or_roles":"Study material importation","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,12,13,15 ('subjects reimbursement'),2,4,5,6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Cardiovascular events adjudication","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Cameras / Subject Photography","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Galen Patient Recruitment Inc.","duties_or_roles":"Recruitment activities in USA and Canada","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"tlssamples@incyte.com","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Povorcitinib
- Active Substance
- POVORCITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- Placebo to Povorcitinib
- Modality
- Other
Related trials
Other published trials that may interest you.