To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

• Sponsor: Incyte Corporation (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04476043
• Collaborator: (none)
• Enrollment: 209
• Locations: 40
• Arms: 4
• Anticipated Duration (Months): 35.6
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa; Acne Inversa	Drug: INCB054707; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 209 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Triple
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
• Actual Study Start Date: Aug 26, 2020
• Actual Primary Completion Date: Dec 15, 2021
• Anticipated Study Completion Date: Aug 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INCB054707 Dose A Participants will receive INCB054707 Dose A for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2). Participants will have the option to continue open-label treatment for an additional 48 weeks.	Drug: INCB054707; Oral; Tablet
Experimental: INCB054707 Dose B Participants will receive INCB054707 Dose B for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2). Participants will have the option to continue open-label treatment for an additional 48 weeks.	Drug: INCB054707; Oral; Tablet
Experimental: INCB054707 Dose C Participants will receive INCB054707 Dose C for 52 weeks (Period 1 + Period 2). Participants will have the option to continue open-label treatment for an additional 48 weeks.	Drug: INCB054707; Oral; Tablet
Placebo Comparator: Placebo followed by INCB054707 Dose C Participants will receive placebo for 16 weeks (Period 1) followed by INCB054707 Dose C for 36 weeks (Period 2). Participants will have the option to continue open-label treatment for an additional 48 weeks.	Drug: Placebo; Oral; Tablet

Outcome Measures

Primary Outcome Measures

1. Mean change in total AN count [Week 16]

   Defined as mean change of Abscess and Inflammatory Nodule (AN) count relative to baseline.

Secondary Outcome Measures

1. Proportion of participants who achieve HiSCR [Week 16]

   HiSCR defined as at least a 50% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

2. Proportion of participants who achieve HiSCR at each visit [Weeks 2 to 12]

   HiSCR defined as at least a 50% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

3. Proportion of participants who achieve HSCR75 at each visit [Weeks 2 to 16]

   HiSCR75 defined as at least a 75% decrease from baseline in AN count with no increase in the number of abscesses or draining fistulas.

4. Mean change in IHS4 at each visit [Weeks 2 to 16]

   Defined as change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4).

5. Proportion of participants achieving AN50, AN75, AN90, and AN100 at each visit [Weeks 2 to 16]

   Defined as reduction in AN count by at least 50%, 75%, 90% and 100% relative to baseline.

6. Mean change in AN count relative to baseline at each visit [Weeks 2 to 12]

   Defined as mean change of Abscess and Inflammatory Nodule (AN) count relative to baseline.

7. Proportion of participants achieving AN of 0 to 2 at each visit [Weeks 2 to 16]

   Defined as Abscess and Inflammatory Nodule (AN) count.

8. Mean change from baseline in the draining fistula count at each visit [Weeks 2 to 16]

   Defined as the mean change from baseline in the draining fistulas count at each visit.

9. Mean change in ANF count at each visit [Weeks 2 to 16]

   Defined as the mean change from baseline in the sum of abscess, inflammatory nodule, and draining fistula count.

10. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [56 or 104 (long-term extension period) weeks]

    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HS disease duration of at least 3 months before screening.

• Willingness to avoid pregnancy or fathering children.

• Active HS in at least 2 distinct anatomical areas.

• Participants agree NOT to use topical antiseptics on the areas affected by HS lesions during the placebo-controlled 16-week treatment period

Exclusion Criteria:

• Draining fistula count of > 20 at screening or baseline.

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

• 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.

• History of failure to treatment of inflammatory diseases with JAK inhibitors.

• Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

• Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

• Laboratory values outside of the protocol-defined ranges.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site 005	Hoover	Alabama	United States	35244
2	Investigative Site 003	Gilbert	Arizona	United States	85295
3	Investigative Site 011	Phoenix	Arizona	United States	85006
4	Investigative Site 014	Fountain Valley	California	United States	92708
5	Investigative Site 010	Fremont	California	United States	94538
6	Investigative Site 012	Huntington Beach	California	United States	92647
7	Investigative Site 022	Newbury Park	California	United States	91320
8	Investigative Site 009	Sacramento	California	United States	95815
9	Investigative Site 025	Cromwell	Connecticut	United States	06416
10	Investigative Site 015	Coral Gables	Florida	United States	33134
11	Investigative Site 021	Miami	Florida	United States	33136
12	Investigative Site 006	Tampa	Florida	United States	33614
13	Investigative Site 001	Tampa	Florida	United States	33624
14	Investigative Site 016	Atlanta	Georgia	United States	30328
15	Investigative Site 002	West Lafayette	Indiana	United States	47906
16	Investigative Site 027	Baton Rouge	Louisiana	United States	70808
17	Investigative Site 023	New Orleans	Louisiana	United States	70112
18	Investigative Site 013	Boston	Massachusetts	United States	02215
19	Investigative Site 004	Fort Gratiot	Michigan	United States	48059
20	Investigative Site 019	Saint Louis	Missouri	United States	63110
21	Investigative Site 026	Bronx	New York	United States	10468
22	Investigative Site 008	Chapel Hill	North Carolina	United States	27516
23	Investigative Site 017	Winston-Salem	North Carolina	United States	27157
24	Investigative Site 007	Hershey	Pennsylvania	United States	17033
25	Investigative Site 018	Bellaire	Texas	United States	77401
26	Investigative Site 101	Calgary	Alberta	Canada	T1Y 0B4
27	Investigative Site 102	Calgary	Alberta	Canada	T3A 0B2
28	Investigative Site 304	Nantes		France	44093
29	Investigative Site 403	Berlin		Germany	10117
30	Investigative Site 401	Bochum		Germany	44791
31	Investigative Site 405	Dessau		Germany	06847
32	Investigative Site 406	Dresden		Germany	01307
33	Investigative Site 404	Erlangen		Germany	91054
34	Investigative Site 402	Frankfurt Am Main		Germany	60590
35	Investigative Site 552	Rzeszow		Poland	35-055
36	Investigative Site 551	Wroclaw		Poland	50-566
37	Investigative Site 553	Wroclaw		Poland	51-318
38	Investigative Site 703	Granada		Spain	18014
39	Investigative Site 702	Madrid		Spain	28007
40	Investigative Site 701	Valencia		Spain	46940

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: NCT04476043
• Other Study ID Numbers: INCB 54707-204
• First Posted: Jul 17, 2020
• Last Update Posted: May 5, 2022
• Last Verified: Apr 1, 2022

• 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
• Additional relevant MeSH terms: Hidradenitis Suppurativa; Hidradenitis

Study Results

No Results Posted as of May 5, 2022