Phase 2
N=209
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Hidradenitis Suppurativa · Acne Inversa
Bottom Line
View on ClinicalTrials.gov: NCT04476043 ↗Enrolled (actual)
209
Serious AEs
2.9%
Results posted
Jan 2023
Primary outcome: Primary: Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 — -2.5; -5.2; -6.9; -6.3 abscesses and inflammatory nodules — p=0.0277
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCB054707 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 |
-2.5; -5.2; -6.9; -6.3 | 0.0277 sig |
| SECONDARY Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 |
28.8; 48.1; 44.2; 45.3 | 0.0445 sig |
| SECONDARY Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12 |
15.4; 25.0; 34.6; 34.0; 25.0; 36.5 | — |
| SECONDARY Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16 |
1.9; 9.6; 13.5; 18.9; 7.7; 15.4 | — |
| SECONDARY Mean Change From Baseline in the Severity of the Disease, as Assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) Score, From Weeks 2 to 16 |
-2.4; -3.8; -6.7; -6.1; -2.1; -3.9 | — |
| SECONDARY Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16 |
15.4; 25.0; 34.6; 39.6; 30.8; 44.2 | — |
| SECONDARY Mean Change From Baseline in AN Count at Weeks 2 to 12 |
-1.7; -2.7; -3.4; -4.0; -3.0; -3.6 | — |
| SECONDARY Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16 |
4.3; 9.8; 16.7; 23.1; 14.3; 20.0 | — |
| SECONDARY Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16 |
2.4; 2.3; 2.2; 1.6; -0.2; -0.2 | — |
| SECONDARY Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16 |
-1.8; -2.9; -4.0; -4.4; -2.7; -3.5 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
34; 31; 30; 32 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04476043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.