A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (STOP-HS1)

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] - Immune System Diseases [C20]

Trial duration

15 Jun 2023 → 23 Dec 2025

Decision date (initial)

2023-05-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Incyte Corporation

External identifiers

EU CT number

2022-501752-29-00

ClinicalTrials.gov

NCT05620823

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacoeconomic, Others, Pharmacokinetic, Therapy, Pharmacodynamic, Safety

To evaluate the efficacy and safety of povorcitinib for the treatment of hidradenitis suppurativa

Secondary objectives 9

1. Key secondary objective: To further evaluate the efficacy of povorcitinib
2. Key secondary objective: To evaluate the effect of povorcitinib in reducing the incidence of flares
3. Key secondary objective: To evaluate the effect of povorcitinib in decreasing skin pain
4. Secondary objective: To further evaluate the effect of povorcitinib in decreasing skin pain
5. Secondary objective: To evaluate the effect of povorcitinib in improving fatigue
6. Secondary objective: To evaluate the effect of povorcitinib on quality of life during the placebo-controlled (PC) and extension (EXT) periods
7. Secondary objective: To further evaluate the efficacy of povorcitinib
8. Secondary objective: To evaluate the efficacy of povorcitinib during the EXT period
9. Secondary objective: To evaluate the maintenance of response during the EXT period

Conditions and MedDRA coding

Hidradenitis Suppurativa

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 10

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Age ≥ 18 years at the time of signing the ICF.
3. Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
4. Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits
5. HS lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least Hurley Stage II or Hurley Stage III, at both the screening and baseline visits.
6. Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS)
7. Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period (unless the systemic antibiotic rescue criterion is met).
8. Agreement to NOT use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the placebo-controlled period. Note: Over-the-counter soap and water is allowed.
9. Agreement to use contraception
10. Willing and able to comply with the study protocol and procedures.

Exclusion criteria 15

1. Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
2. Women who are pregnant (or who are considering pregnancy) or breastfeeding.
3. Concurrent conditions or history of other diseases (as per section 5.2 of the protocol)
4. A screening 12-lead 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 criteria associated with Q wave interval (QT)/Fridericia-corrected Q wave interval (QTcF) abnormalities.
5. Have undergone significant trauma or major surgery (per investigator's assessment) within 30 days preceding the screening visit.
6. History of clinically significant (per investigator's judgment) drug or alcohol abuse within 6 months preceding the screening visit.
7. History of treatment failure with any systemic or topical JAK inhibitor for HS or any other inflammatory condition
8. Receipt of medical treatment or investigational drugs before the baseline visit within the intervals specified in section 5.2 of the protocol
9. At the screening visit, any of the laboratory abnormalities defined in the protocol Table 9
10. Evidence of infection with Mycobacterium tuberculosis
11. Active HIV or acquired immunodeficiency syndrome. Active HIV is defined as confirmed positive anti-HIV antibody test
12. Evidence of HBV or HCV infection or risk of reactivation
13. Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
14. 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.
15. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

Secondary endpoints 22

1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12.
2. Proportion of participants with flare by Week 12.
3. Proportion of participants who achieve Skin Pain NRS30 at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.
4. Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score at Week 12 among participants with baseline Skin Pain NRS score ≥ 3.
5. Proportion of participants with at least a 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) score at Week 12.
6. Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit.
7. Mean change from baseline in abscess count at each visit.
8. Percentage change from baseline in abscess count at each visit.
9. Mean change from baseline in inflammatory nodule count at each visit.
10. Percentage change from baseline in inflammatory nodule count at each visit.
11. Mean change from baseline in draining tunnel count at each visit.
12. Percentage change from baseline in draining tunnel count at each visit.
13. Proportion of participants who achieve HiSCR at Week 24.
14. Proportion of participants who achieve HiSCR75 at Week 24.
15. Proportion of participants with flare by Week 24.
16. Proportion of participants who achieved Skin Pain NRS30 at Week 24 among participants with baseline Skin Pain NRS score ≥ 3.
17. Proportion of participants who achieve HiSCR at Week 54.
18. Proportion of participants who achieve HiSCR75 at Week 54.
19. Proportion of participants with flare by Week 54.
20. Proportion of participants who achieved Skin Pain NRS30 at Week 54 among participants with baseline Skin Pain NRS score ≥ 3.
21. Proportion of participants who achieve maintenance of HiSCR or greater response at each visit during the EXT period.
22. Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit during the EXT period.

Investigational products

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

Test 2

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 9

Locations

9 EU/EEA countries · 45 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 145 files

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

Application history

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