Selective Treatment of Oral Povorcitinib in Vitiligo Study 2 (STOP-V2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

17 Apr 2024 → ongoing

Decision date (initial)

2024-03-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

To compare the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo.

Secondary objectives 2

1. To further compare the efficacy of povorcitinib to placebo at Week 52 in adult participants with nonsegmental vitiligo.
2. To compare participants' perception of treatment response for povorcitinib versus placebo at Week 52.

Conditions and MedDRA coding

Vitiligo

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Ability to comprehend and willingness to sign a written ICF for the study.
2. 2. Aged ≥ 18 years at the time of consent.
3. 3. Clinical diagnosis of nonsegmental vitiligo and meet the screening and baseline criteria listed in section 5.1.3 of the protocol
4. 4. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
5. 5. Willingness to avoid pregnancy or fathering children based on the criteria listed in the section 5.1.5 of the protocol.
6. 6. Willing and able to comply with the study Protocol and procedures, including photography.

Exclusion criteria 25

1. 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).
2. 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).
3. 19. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
4. 2. Clinically significant abnormal thyroid-stimulating hormone (TSH) or free thyroxine (T4) at screening as determined by the investigator.
5. 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.
6. 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.
7. 3. Use of laser or light-based treatment (phototherapy), including tanning beds, within 8 weeks prior to Day 1.
8. 4. Use of dihydroxyacetone (generally present in self-tanning products) within 4 weeks prior to Day 1.
9. 5. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone, including Benoquin® (monobenzone).
10. 6. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
11. 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).
12. 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.
13. 8. Women who are pregnant, considering pregnancy, or breastfeeding.
14. 9. Concurrent conditions or history of other diseases, as listed in section 5.2.9 of the protocol
15. 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.
16. 11. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
17. 12. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
18. 13. History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or any other inflammatory condition.
19. 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)
20. 15. At the screening visit, any of the laboratory abnormalities defined in Table 10 of the protocol
21. 16. Evidence of infection with Mycobacterium tuberculosis (ie, TB) as defined in Section 8.3.5.2. of the protocol
22. 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. 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. 24. Had ≥ 3 laser hair removal treatments of an area to be treated for vitiligo.
25. 25. Concurrent enrollment in another clinical study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving ≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI75) at Week 52.

Secondary endpoints 4

1. Percentage change from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 52.
2. Proportion of participants achieving ≥ 50% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI50) at Week 52
3. Proportion of participants achieving ≥ 75% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI75) at Week 52
4. Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 52.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 12

Locations

6 EU/EEA countries · 42 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 83 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications