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Selective Treatment of Oral Povorcitinib in Vitiligo Study 2 (STOP-V2)
EU CTIS ID: 2023-506011-18-00
What this study is testing
To compare the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Ability to comprehend and willingness to sign a written ICF for the study.
- 2. Aged ≥ 18 years at the time of consent.
- 3. Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol
- 4. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
- 5. Willingness to avoid pregnancy or fathering children based on the criteria listed in the section 5.1.5 of the protocol.
- 6. Willing and able to comply with the study Protocol and procedures, including photography.
You likely can't join if
- 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).
- 6. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
- 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).
- 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.
- 8. Women who are pregnant, considering pregnancy, or breastfeeding.
- 9. Concurrent conditions or history of other diseases, as listed in section 5.2.9 of the protocol
See the full eligibility criteria
Who can join
- 1. Ability to comprehend and willingness to sign a written ICF for the study.
- 2. Aged ≥ 18 years at the time of consent.
- 3. Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol
- 4. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
- 5. Willingness to avoid pregnancy or fathering children based on the criteria listed in the section 5.1.5 of the protocol.
- 6. Willing and able to comply with the study Protocol and procedures, including photography.
What rules you out
- 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).
- 6. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
- 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).
- 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.
- 8. Women who are pregnant, considering pregnancy, or breastfeeding.
- 9. Concurrent conditions or history of other diseases, as listed in section 5.2.9 of the protocol
- 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.
- 11. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
- 12. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
- 13. History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or any other inflammatory condition.
- 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)
- 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).
- 15. At the screening visit, any of the laboratory abnormalities defined in Table 10 of the protocol
- 16. Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2. of the protocol
- 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).
- 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.
- 24. Had ≥ 3 laser hair removal treatments of an area to be treated for vitiligo.
- 25. Concurrent enrollment in another clinical study.
- 19. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
- 2. Clinically significant abnormal thyroid-stimulating hormone (TSH) or free thyroxine (T4) at screening as determined by the investigator.
- 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.
- 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.
- 3. Use of laser or light-based treatment (phototherapy), including tanning beds, within 8 weeks prior to Day 1.
- 4. Use of dihydroxyacetone (generally present in self-tanning products) within 4 weeks prior to Day 1.
- 5. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (monobenzone).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- China
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; China; Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.