Selective Treatment of Oral Povorcitinib Long-Term Rollover Study (STOP-LTR)

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

3 Sep 2025 → ongoing

Decision date (initial)

2025-08-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

External identifiers

EU CT number

2024-520107-12-00

ClinicalTrials.gov

NCT06855498

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To continue evaluating the long-term safety of povorcitinib

Secondary objectives 3

1. For HS indication: To continue evaluating the longterm efficacy of povorcitinib in participants with HS
2. For vitiligo indication: To continue evaluating the long-term efficacy of povorcitinib in participants with vitiligo
3. For PN indication: To continue evaluating the long-term efficacy of povorcitinib in participants with PN

Conditions and MedDRA coding

Hidradenitis Suppurativa // Prurigo Nodularis // Vitiligo

Study design 1 period

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003313-PIP03-23, EMEA-003313-PIP01-22

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
3. Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
4. Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
5. Willingness to avoid pregnancy or fathering children as per section 5.1.5 of the protocol.
6. Willingness and ability to comply with the study Protocol and procedures.

Exclusion criteria 9

1. Had been permanently discontinued from study treatment during the parent study.
2. Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
3. [Commercial Confidential Information]
4. [Commercial Confidential Information]
5. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
6. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib (refer to the IB) and/or other products in the same class.
7. Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
8. Any condition that would, in the investigator's and/or sponsor'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.
9. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. TEAEs reported in participants receiving povorcitinib

Secondary endpoints 5

1. For HS indication: ANdT count of 0-2 at each visit
2. For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in F-VASI score at each visit
3. For vitiligo indication: Change from baseline of the initial parent study (INCB 54707-303 or INCB 54707-304) in T-VASI score at each visit
4. For PN indication: Itch NRS score of 0 or 1 at each visit
5. For PN indication: IGA-CPG-S score of 0 or 1 at each visit

Investigational products

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

Test 3

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 5

Locations

13 EU/EEA countries · 123 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 88 files

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

Application history

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