Clinical trial • Phase III • Dermatology

POVORCITINIB for Nonsegmental vitiligo

Phase III trial of POVORCITINIB for Nonsegmental vitiligo.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Nonsegmental vitiligo
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
24-11-2023
First CTIS Authorization Date
03-04-2024

Trial design

Randomised, open-label, arms: povorcitinib (active) and placebo to povorcitinib (placebo control). doses and schedule not specified in the ctis record. Phase III trial across 31 sites in Netherlands, Spain, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Arms: Povorcitinib (active) and Placebo to Povorcitinib (placebo control). Doses and schedule not specified in the CTIS record.
Target Sample Size
444
Trial Duration For Participant
364

Eligibility

Recruits 444 Participants must have the ability to comprehend and be willing to sign a written informed consent form. Vulnerable populations are explicitly excluded in France per the exclusion: "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.".

Pregnancy Exclusion
8. Women who are pregnant, considering pregnancy, or breastfeeding.
Vulnerable Population
Participants must have the ability to comprehend and be willing to sign a written informed consent form. Vulnerable populations are explicitly excluded in France per the exclusion: "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."

Inclusion criteria

  • {"criterion_text":"- Ability to comprehend and willingness to sign a written ICF for the study.\n- Aged ≥ 18 years at the time of consent.\n- Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol\n- Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.\n- Willingness to avoid pregnancy or fathering children based on the criteria listed in the section 5.1.5 of the protocol.\n- 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."}

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 from baseline in T-VASI measured at 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 achieving ≥50% improvement from baseline in T-VASI at Week 52."}
  • {"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 achieving ≥75% improvement from baseline in T-VASI at Week 52."}
  • {"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 with VNS response categories 4 or 5 at Week 52 (participant-reported noticeability)."}

Recruitment

Planned Sample Size
444
Recruitment Window Months
39
Consent Approach
Adults (aged ≥18) must provide written informed consent; inclusion requires ability to comprehend and willingness to sign a written ICF. Optional photography consent and specific partner/pregnancy information documents are included. ICF and related participant documents are provided in multiple language versions (examples in the file list include English, Dutch, French) and versions for country-specific use.

Methods

  • Recruitment activities in USA and Canada by Galen Patient Recruitment Inc. (contact: info@galenrecruitment.com) as listed in sponsor third-party duties.
  • Site-based recruitment at participating dermatology clinics and hospitals in the participating countries (sites listed for each Member State).

Geography

Total Number Of Sites
31
Total Number Of Participants
203

Netherlands

Earliest CTIS Part Ii Submission Date
14-12-2023
Latest Decision Or Authorization Date
13-03-2025
Processing Time Days
455
Number Of Sites
2
Number Of Participants
14

Sites

Site Name
Amsterdam UMC
Department Name
Department of Dermatology/Netherlands Institute for Pigment Disorders
Principal Investigator Name
Albert Wolkerstorfer
Principal Investigator Email
a.wolkerstorfer@amsterdamumc.nl
Contact Person Name
Albert Wolkerstorfer
Site Name
Bravis Ziekenhuis
Department Name
Department of Dermatology
Principal Investigator Name
Milan Tjioe
Principal Investigator Email
m.tjioe@bravis.nl
Contact Person Name
Milan Tjioe
Contact Person Email
m.tjioe@bravis.nl

Spain

Earliest CTIS Part Ii Submission Date
14-12-2023
Latest Decision Or Authorization Date
10-03-2025
Processing Time Days
452
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Dermatology
Principal Investigator Name
Pedro Redondo Bellon
Principal Investigator Email
predondo@unav.es
Contact Person Name
Pedro Redondo Bellon
Contact Person Email
predondo@unav.es
Site Name
Hospital Clinic De Barcelona
Department Name
Dermatology
Principal Investigator Name
Paula Aguilera Peiro
Principal Investigator Email
paguile@clinic.cat
Contact Person Name
Paula Aguilera Peiro
Contact Person Email
paguile@clinic.cat
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Dermatology
Principal Investigator Name
Jose Luis Lopez Estebaranz
Principal Investigator Email
jlestebaranz@salud.madrid.org
Contact Person Name
Jose Luis Lopez Estebaranz
Contact Person Email
jlestebaranz@salud.madrid.org
Site Name
Hospital Germans Trias I Pujol
Department Name
Dermatology
Principal Investigator Name
Ane Jaka Moreno
Principal Investigator Email
ajaka.germanstrias@gencat.cat
Contact Person Name
Ane Jaka Moreno
Contact Person Email
ajaka.germanstrias@gencat.cat
Site Name
Hospital De Manises
Department Name
Dermatology
Principal Investigator Name
Antonio Martorell Calatayud
Principal Investigator Email
amartorell@hospitalmanises.es
Contact Person Name
Antonio Martorell Calatayud
Contact Person Email
amartorell@hospitalmanises.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Dermatology
Principal Investigator Name
Gonzalo Segurado Miravalles
Principal Investigator Email
drsegurado@gmail.com
Contact Person Name
Gonzalo Segurado Miravalles
Contact Person Email
drsegurado@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
14-02-2024
Latest Decision Or Authorization Date
16-04-2025
Processing Time Days
427
Number Of Sites
5
Number Of Participants
27

Sites

Site Name
Derma-Study-Center Friedrichshafen GmbH
Principal Investigator Name
Peter Radny
Principal Investigator Email
info@dsc-fn.de
Contact Person Name
Peter Radny
Contact Person Email
info@dsc-fn.de
Site Name
Beldio Research GmbH
Principal Investigator Name
Nicolai Treiber
Principal Investigator Email
schagen@beldio.com
Contact Person Name
Nicolai Treiber
Contact Person Email
schagen@beldio.com
Site Name
BAG Dres. med. Quist PartG
Principal Investigator Name
Sven Quist
Principal Investigator Email
studie@dermatologie-quist.de
Contact Person Name
Sven Quist
Contact Person Email
studie@dermatologie-quist.de
Site Name
Goethe University Frankfurt
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Principal Investigator Name
Andreas Pinter
Principal Investigator Email
andreas.pinter@kgu.de
Contact Person Name
Andreas Pinter
Contact Person Email
andreas.pinter@kgu.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik
Principal Investigator Name
Michael Sticherling
Principal Investigator Email
michael.sticherling@uk-erlangen.de
Contact Person Name
Michael Sticherling

France

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
27-02-2025
Processing Time Days
402
Number Of Sites
4
Number Of Participants
28

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service de Dermatologie et Dermatologie Pediatrique
Principal Investigator Name
Julien Seneschal
Principal Investigator Email
julien.seneschal@chu-bordeaux.fr
Contact Person Name
Julien Seneschal
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Dermatologie
Principal Investigator Name
Khaled Ezzedine
Principal Investigator Email
khaled.ezzedine@aphp.fr
Contact Person Name
Khaled Ezzedine
Contact Person Email
khaled.ezzedine@aphp.fr
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
Courlancy Sante
Department Name
Service de Dermatologie
Principal Investigator Name
Ziad Reguiai
Principal Investigator Email
dr-reguiai@orange.fr
Contact Person Name
Ziad Reguiai
Contact Person Email
dr-reguiai@orange.fr

Belgium

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
06-03-2025
Processing Time Days
367
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
CHU De Liege
Department Name
Dermatology
Principal Investigator Name
Arjen Nikkels
Principal Investigator Email
af.nikkels@chuliege.be
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Hopital Erasme
Department Name
Dermatology
Principal Investigator Name
Veronique Del Marmol
Principal Investigator Email
veronique.delmarmol@hubruxelles.be
Contact Person Name
Veronique Del Marmol
Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Principal Investigator Name
Nanny (Nanja) Van Geel
Principal Investigator Email
nanja.vangeel@uzgent.be
Contact Person Name
Nanny (Nanja) Van Geel
Contact Person Email
nanja.vangeel@uzgent.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology
Principal Investigator Name
Pierre-Dominique Ghislain
Principal Investigator Email
pierre-dominique.ghislain@uclouvain.be
Contact Person Name
Pierre-Dominique Ghislain

Poland

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
650
Number Of Sites
10
Number Of Participants
98

Sites

Site Name
NZOZ Dermedic
Department Name
Poradnia dermatologiczna
Principal Investigator Name
Katarzyna Wolska-Gawron
Principal Investigator Email
jacek_z@icloud.com
Contact Person Name
Katarzyna Wolska-Gawron
Contact Person Email
jacek_z@icloud.com
Site Name
Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska
Department Name
NA/ND
Principal Investigator Name
Edyta Gębska
Principal Investigator Email
egebska@dermapolis.com
Contact Person Name
Edyta Gębska
Contact Person Email
egebska@dermapolis.com
Site Name
DermoDent Centrum Medyczne Aldona Czajkowska Rafal Czajkowski s.c.
Department Name
NA/ND
Principal Investigator Name
Rafał Czajkowski
Principal Investigator Email
r.czajkowski@dermodent.pl
Contact Person Name
Rafał Czajkowski
Contact Person Email
r.czajkowski@dermodent.pl
Site Name
Etg Warszawa Sp. z o.o.
Department Name
NA/ND
Principal Investigator Name
Maria Zegadło-Mylik
Principal Investigator Email
m.zegadlomylik@etg-network.com
Contact Person Name
Maria Zegadło-Mylik
Contact Person Email
m.zegadlomylik@etg-network.com
Site Name
Synexus Polska Sp. z o.o.
Department Name
Oddział w Warszawie
Principal Investigator Name
Ryszard Galus
Principal Investigator Email
ryszard.galus@glonalaes.com
Contact Person Name
Ryszard Galus
Contact Person Email
ryszard.galus@glonalaes.com
Site Name
Carpe Diem Centrum Medycyny Estetycznej
Department Name
Magdalena Opadczuk Carpe Diem Centrum Medycyny Estetycznej
Principal Investigator Name
Weronika Molga
Principal Investigator Email
wmolga@carpediempl.eu
Contact Person Name
Weronika Molga
Contact Person Email
wmolga@carpediempl.eu
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Dermatologii, Wenerologii i Alergologii
Principal Investigator Name
Roman Nowicki
Principal Investigator Email
rnowicki@gumed.edu.pl
Contact Person Name
Roman Nowicki
Contact Person Email
rnowicki@gumed.edu.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Klinika Dermatologii
Principal Investigator Name
Irena Walecka-Herniczek
Principal Investigator Email
dermatologia@cskmswia.gov.pl
Contact Person Name
Irena Walecka-Herniczek
Contact Person Email
dermatologia@cskmswia.gov.pl
Site Name
Dermedic Jacek Zdybski
Department Name
NA/ND
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
EMC Instytut Medyczny S.A.
Department Name
Penta Hospitals Przychodnie, Wrocław Wejherowska
Principal Investigator Name
Anna Domagała
Principal Investigator Email
aniad05@gmail.com
Contact Person Name
Anna Domagała
Contact Person Email
aniad05@gmail.com

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 sponsor/CRO responsibilities including site management and subjects reimbursement (codes listed in CTIS record); contact CTISAuthorityCommunications-Pharma@iconplc.com
Name
IQVIA Limited
Responsibilities
Cardiovascular events adjudication (eu_clinical_trials_information@iqvia.com)

Third parties

  • {"country":"United States","full_name":"Incyte Corp.","duties_or_roles":"sponsor duties code: 4 (contact tlssamples@incyte.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"eCOA (electronic clinical outcome assessment); contact INCB54707_303_304@signanthealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Olink Proteomics Inc.","duties_or_roles":"sponsor duties code: 4 (service_boston@olink.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsor duties code: 3 (green@suvoda.com)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Kintetsu World Express (Benelux) B.V.","duties_or_roles":"Study Material importation (icon@tecexmedical.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsor duties code: 7 (CDMS_Support@veeva.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Cameras / Subject Photography (INCB54707-303@canfieldsci.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsor duties code: 4 (dnaseq@azenta.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Study supplies like Wood lamps , incubators, freeezers (Info@mesm.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Cardiovascular events adjudication (eu_clinical_trials_information@iqvia.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Galen Patient Recruitment Inc.","duties_or_roles":"Recruitment activities in USA and Canada (info@galenrecruitment.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple sponsor duties including site management and subjects reimbursement (CTISAuthorityCommunications-Pharma@iconplc.com); sponsor duties codes: 1,12,13,15,2,4,5,6","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.