Hidradenitis SuppurativaPhase 2NCT04476043
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
A Phase 2 study testing INCB054707 in people with Hidradenitis Suppurativa and Acne Inversa, run by Incyte Corporation at 40 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa, Acne Inversa
- What is being tested?
- INCB054707
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 40 sitesin 6 countries
- Study dates
- 25 Aug 2020to 16 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States25 sites
Investigative Site 016
Atlanta, Georgia, 30328
Investigative Site 027
Baton Rouge, Louisiana, 70808
Investigative Site 018
Bellaire, Texas, 77401
Investigative Site 013
Boston, Massachusetts, 02215
Investigative Site 008
Chapel Hill, North Carolina, 27516
Investigative Site 015
Coral Gables, Florida, 33134
Investigative Site 025
Cromwell, Connecticut, 06416
Investigative Site 004
Fort Gratiot, Michigan, 48059
Investigative Site 014
Fountain Valley, California, 92708
Investigative Site 010
Fremont, California, 94538
Investigative Site 003
Gilbert, Arizona, 85295
Investigative Site 007
Hershey, Pennsylvania, 17033
Investigative Site 005
Hoover, Alabama, 35244
Investigative Site 012
Huntington Beach, California, 92647
Investigative Site 021
Miami, Florida, 33136
Investigative Site 023
New Orleans, Louisiana, 70112
Investigative Site 022
Newbury Park, California, 91320
Investigative Site 011
Phoenix, Arizona, 85006
Investigative Site 009
Sacramento, California, 95815
Investigative Site 019
St Louis, Missouri, 63110
Investigative Site 006
Tampa, Florida, 33614
Investigative Site 001
Tampa, Florida, 33624
Investigative Site 026
The Bronx, New York, 10468
Investigative Site 002
West Lafayette, Indiana, 47906
Investigative Site 017
Winston-Salem, North Carolina, 27157
Germany6 sites
Investigative Site 403
Berlin, 10117
Investigative Site 401
Bochum, 44791
Investigative Site 405
Dessau, 06847
Investigative Site 406
Dresden, 01307
Investigative Site 404
Erlangen, 91054
Investigative Site 402
Frankfurt am Main, 60590
Poland3 sites
Investigative Site 552
Rzeszów, 35-055
Investigative Site 551
Wroclaw, 50-566
Investigative Site 553
Wroclaw, 51-318
Spain3 sites
Investigative Site 703
Granada, 18014
Investigative Site 702
Madrid, 28007
Investigative Site 701
Valencia, 46940
Canada2 sites
Investigative Site 101
Calgary, Alberta, T1Y 0B4
Investigative Site 102
Calgary, Alberta, T3A 0B2
About this study
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
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).
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Being tested
- INCB054707, Placebo
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB054707Drug
Also called Povorcitinib
Oral; Tablet
PlaceboDrug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| INCB054707 15 mg | Experimental | Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. Receives: Drug: INCB054707 |
| INCB054707 45 mg | Experimental | Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. Receives: Drug: INCB054707 |
| INCB054707 75 mg | Experimental | Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks. Receives: Drug: INCB054707 |
| Placebo followed by INCB054707 75 mg | Placebo comparator | Participants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Measured: Baseline; Week 16
Secondary outcomes (10)
Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Measured: Baseline; Week 16
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Measured: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas.
Measured: Baseline; Weeks 2, 4, 6, 8, 12, and 16
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
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Measured: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count.
Measured: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in AN Count at Weeks 2 to 12
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Measured: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Total AN count was assessed throughout the study.
Measured: Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
Measured: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Measured: up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start25 Aug 2020
- Primary completion15 Dec 2021
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476043
- Sponsor's protocol ID
- INCB 54707-204
- Other IDs
- 2020-001981-13
- Status last verified
- Aug 2025
- First submitted
- 15 Jul 2020
- Last updated
- 12 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04476043
- Acronym / sponsor ID
- INCB 54707-204
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INCB054707 15 mg | Experimental | Drug: INCB054707Participants will receive INCB054707 15 milligrams (mg) for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
| INCB054707 45 mg | Experimental | Drug: INCB054707Participants will receive INCB054707 45 mg for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
| INCB054707 75 mg | Experimental | Drug: INCB054707Participants will receive INCB054707 75 mg for 52 weeks in the Placebo-controlled Treatment Period (16 weeks) plus the Open-label Extension Period (36 weeks). Participants will have the option to continue open-label treatment for an additional 48 weeks. |
| Placebo followed by INCB054707 75 mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo for 16 weeks in the Placebo-controlled Treatment Period, followed by INCB054707 75 mg for 36 weeks in the Open-label Extension Period. Participants will have the option to continue open-label treatment for an additional 48 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB054707Also: PovorcitinibOral; Tablet | Drug | INCB054707 15 mg, INCB054707 45 mg, INCB054707 75 mg |
| PlaceboOral; Tablet | Drug | Placebo followed by INCB054707 75 mg |
Primary outcome
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
Time frame: Baseline; Week 16
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and INCB054707 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
10 secondary outcomes
Percentage of Participants Who Achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Time frame: Baseline; Week 16
Percentage of Participants Who Achieved a HiSCR at Weeks 2 Through 12
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants Who Achieved HiSCR75 From Weeks 2 to 16
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
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
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Percentage of Participants Who Achieved AN50, AN75, AN90, and AN100 From Weeks 2 to 16
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in AN Count at Weeks 2 to 12
Time frame: Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With a Total AN Count of 0 to 2 From Weeks 2 to 16
Time frame: Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in Draining Fistula Count From Weeks 2 to 16
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Mean Change From Baseline in Abscess, Inflammatory Nodule (IN), and Draining Fistula (DF) (ANF) Count From Weeks 2 to 16
Time frame: Baseline; Weeks 2, 4, 6, 8, 12, and 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: up to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB054707 in people with Hidradenitis Suppurativa and Acne Inversa, run by Incyte Corporation at 40 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, Poland, Spain, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 (time frame: Baseline; Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.