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

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05620823
• Collaborator: (none)
• Enrollment: 600
• Locations: 45
• Arms: 3
• Anticipated Duration (Months): 37.4
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo controlled period, followed by a 42-week extension period.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa (HS)	Drug: Povorcitinib; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.Participants will be randomized 1:1:1 to Povorcitinib Dose A, Povorcitinib Dose B, or placebo once a day (QD); participants who complete the placebo controlled (PC) 12-week period may continue to a 42-week extension(EXT) period with Povorcitinib (Dose A or Dose B) QD.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa
• Actual Study Start Date: Dec 19, 2022
• Anticipated Primary Completion Date: Mar 11, 2025
• Anticipated Study Completion Date: Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Povorcitinib Dose A Participants will receive Povorcitinib Dose A for 54 weeks.	Drug: Povorcitinib; Oral; Tablet; Other Names: INCB054707
Experimental: Povorcitinib Dose B Participants will receive Povorcitinib Dose B for 54 weeks.	Drug: Povorcitinib; Oral; Tablet; Other Names: INCB054707
Placebo Comparator: Placebo Participants will receive Placebo for 12 weeks, followed by Povorcitinib (Dose A or Dose B) for 42 weeks.	Drug: Placebo; Oral; Tablet

Outcome Measures

Primary Outcome Measures

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

   HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

Secondary Outcome Measures

1. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Week 12]

   HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

2. Proportion of participants with flare [12 weeks]

   Participants who experience at least 1 flare over 12 weeks; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

3. Proportion of participants with a ≥ 3-point decrease in Skin Pain Numeric Rating Scale (NRS) score among participants with baseline Skin Pain NRS score ≥ 3. [Week 12]

   Participants with a Skin Pain score of at least 3 at baseline and who experience at least a 3-point decrease in Skin Pain score at Week 12, relative to baseline. Skin Pain is an 11 point NRS, ranging from 0 (no skin pain) to 10 (worst skin pain).

4. Proportion of participants who achieve Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [Week 12]

   Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 12 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

5. Proportion of participants with a ≥ 4-point increase from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT F) score [Week 12]

   Participants with a baseline FACIT-F score ≤ 48 and who experience at least a 4-point increase in FACIT-F score at Week 12, relative to baseline. The FACIT-F scale is a 13-item questionnaire that assesses self reported fatigue and its impact upon daily activities and function over the past 7 days, with scores ranging from 0 (worst fatigue) to 52 (no fatigue).

6. Mean change from baseline in Dermatology Life Quality Index (DLQI) score at each visit [54 weeks]

   The DLQI is a skin disease specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (QoL). The DLQI total score ranges from 0 to 30, with higher scores indicating lower skin health related QoL.

7. Mean change from baseline in abscess count at each visit. [54 weeks]

   Defined as mean change of Abscess count relative to baseline.

8. Percentage change from baseline in abscess count at every visit [54 weeks]

   Percent change from baseline in number of abscess(es)

9. Mean change from baseline in inflammatory nodule count at each visit [54 weeks]

   Defined as mean change of inflammatory nodule count relative to baseline.

10. Percentage change from baseline in inflammatory nodule count at each visit. [54 weeks]

    Defined as percent change from baseline in number of inflammatory nodule(s)

11. Mean change from baseline in draining tunnel count at each visit. [54 weeks]

    Defined as mean change of draining tunnel count relative to baseline.

12. Percentage change from baseline in draining tunnel count at each visit. [54 weeks]

    Defined as percent change from baseline in number of draining tunnel(s)

13. Extension Period: Proportion of participants who achieve HiSCR [Week 24]

    HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

14. Extension Period: Proportion of participants who achieve HiSCR75 [Week 24]

    HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

15. Extension Period: Proportion of participants with flare [From Week 12 through Week 24]

    Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

16. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3 [Week 24]

    Skin Pain NRS30 defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

17. Extension Period: Proportion of participants who achieve HiSCR [Week 54]

    HiSCR is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count

18. Extension Period: Proportion of participants who achieve HiSCR75 [Week 54]

    HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.

19. Extension Period : Proportion of participants with flare [From Week 12 through Week 54]

    Participants who experience at least 1 flare over the period under assessment; flare is defined as at least a 25% increase in the total abscess and inflammatory nodule count with a minimum increase of 2 relative to baseline.

20. Extension Period: Proportion of participants who achieved Skin Pain NRS30 among participants with baseline Skin Pain NRS score ≥ 3. [Week 54]

    Participants with a Skin Pain score of at least 3 at baseline and who achieve at Week 24 Skin Pain NRS30, defined as at least a 30% reduction and at least 1-unit reduction from baseline in the Skin Pain NRS.

21. Extension Period:Proportion of participants who achieve maintenance of HiSCR or greater response at each visit [From Week 12 through Week 54]

    Maintenance of response defined as participants who achieve HiSCR at Week 12 and maintain it or achieve greater response at each visit during the EXT period.

22. Extension Period : Proportion of participants who achieve maintenance of HiSCR75 or greater response at each visit [From Week 12 through Week 54]

    Maintenance of response defined as participants who achieve HiSCR75 at Week 12 and maintain it or achieve greater response at each visit during the EXT period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.

• Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits

• 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

• 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).

• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the placebo-controlled period.

• 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.

• Agreement to use contraception

• Willing and able to comply with the study protocol and procedures.

• Further inclusion criteria apply.

Exclusion Criteria:

• Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.

• Women who are pregnant (or who are considering pregnancy) or breastfeeding.

• Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.

• Laboratory values outside of the protocol-defined ranges.

• Further exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site US303	Phoenix	Arizona	United States	85006
2	Investigative Site US323	San Francisco	California	United States	94118
3	Investigative Site US306	Boca Raton	Florida	United States	33486
4	Investigative Site US320	Boca Raton	Florida	United States	33486
5	Investigative Site US317	Hialeah	Florida	United States	33012-3618
6	Investigative Site US321	North Miami Beach	Florida	United States	33162-4708
7	Investigative Site US322	Ann Arbor	Michigan	United States	48109
8	Investigative Site US300	Plano	Texas	United States	75025
9	Investigative Site AT304	Graz		Austria	08036
10	Investigative Site AT302	Linz		Austria	04020
11	Investigative Site AT303	Vienna		Austria	01030
12	Investigative Site AT305	Wien		Austria	01090
13	Investigative Site AT301	Wien		Austria	01100
14	Investigative Site AT300	Wien		Austria	01130
15	Investigative Site BE304	Brussels		Belgium	01200
16	Investigative Site BE301	Gent		Belgium	09000
17	Investigative Site BE306	Gent		Belgium	09000
18	Investigative Site BE305	Leuven		Belgium	03000
19	Investigative Site BE302	Liege		Belgium	04000
20	Investigative Site BE303	Namur		Belgium	05000
21	Investigative Site CA301	Winnipeg	Manitoba	Canada	R3M 3Z4
22	Investigative Site CA304	Barrie	Ontario	Canada	L4M 1G7
23	Investigative Site CA303	London	Ontario	Canada	N6H 5L5
24	Investigative Site CA305	Newmarket	Ontario	Canada	L3Y 5G8
25	Investigative Site CA302	Peterborough	Ontario	Canada	K9J 5K2
26	Investigative Site CA306	Laval	Quebec	Canada	H7N 6L2
27	Investigative Site CA307	Montreal	Quebec	Canada	H2K 4L5
28	Investigative Site CZ301	Ostrava - Poruba		Czechia	708 52
29	Investigative Site CZ300	Praha 5		Czechia	150 06
30	Investigative Site FR301	Saint Etienne Cedex 2		France	42055
31	Investigative Site DE302	Dresden		Germany	01307
32	Investigative Site DE306	Duesseldorf		Germany	40225
33	Investigative Site DE301	Frankfurt		Germany	60590
34	Investigative Site DE303	Hamburg		Germany	20246
35	Investigative Site DE300	Hannover		Germany	30519
36	Investigative Site DE305	Hessen		Germany	64297
37	Investigative Site DE304	Langenau		Germany	89129
38	Investigative Site DE307	Memmingen		Germany	87700
39	Investigative Site PL301	Wroclaw		Poland	50-566
40	Investigative Site ES302	Badalona		Spain	08916
41	Investigative Site ES303	Barcelona		Spain	08003
42	Investigative Site ES301	Granada		Spain	18014
43	Investigative Site ES305	Madrid		Spain	28041
44	Investigative Site ES300	Pontevedra		Spain	36001
45	Investigative Site ES304	Santiago de Compostela		Spain	15706

Sponsors and Collaborators

• Incyte Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT05620823
• Other Study ID Numbers: INCB 54707-301
• First Posted: Nov 17, 2022
• Last Update Posted: Jan 13, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Incyte Corporation: Hidradenitis Suppurativa; Hidradenitis; Acne inversa; HS; INCB054707; Povorcitinib
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis

Study Results

No Results Posted as of Jan 13, 2023