Hidradenitis SuppurativaPhase 2NCT03607487
A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
A Phase 2 study testing INCB054707 in people with Hidradenitis Suppurativa, run by Incyte Corporation at 13 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- 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
- 35 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 15 Oct 2018to 13 Aug 2019
- 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
- Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
- Stable course of HS for at least 90 days before screening, as determined by the investigator.
- HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or Hurley Stage III at screening.
- Total AN count of at least 3 at screening and baseline.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- Women who are currently pregnant or lactating.
- Presence of > 20 draining fistulas at screening and baseline.
- Participants with protocol-defined concurrent conditions or history of other diseases.
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
- A history of active tuberculosis (treated or untreated) or a history of untreated latent tuberculosis.
Show all 13Show fewer
- Positive serology test results for HIV, hepatitis B surface antigen, hepatitis B virus core antibody, or hepatitis C virus (HCV antibody with positive HCV-RNA) at screening.
- Decreased blood cell counts at screening per protocol-defined criteria.
- Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase or aspartate aminotransferase levels ≥ 1.5 × upper limit of normal at screening.
- Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
- Use of protocol-prohibited medications.
- Known or suspected allergy to INCB054707 or any component of the study drug.
- Known history of clinically significant drug or alcohol abuse in the last year before baseline.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Canada9 sites
Investigative Site
Barrie, Ontario, L4M 7G1
Investigative Site
Drummondville, Quebec, J2B 5L4
Investigative Site
Fredericton, New Brunswick, E3B 1G9
Investigative Site
London, Ontario, N6H 5L5
Investigative Site 009
Markham, Ontario, L3P 1X2
Investigative Site 008
Richmond Hill, Ontario, L4C 9M7
Investigative Site
Saint-Jérôme, Quebec, J7Z 7E2
Investigative Site 007
Windsor, Ontario, N8W 5L7
Investigative Site
Winnipeg, Manitoba, R3M 3Z4
Denmark2 sites
Investigative Site
Aarhus, 8200
Investigative Site
Roskilde, 4000
Germany2 sites
Investigative Site
Bochum, Noth Rhine-Westphalia, 44791
Investigative Site
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- INCB054707, Placebo
- Keywords
- Hidradenitis suppurativa, Janus kinase (JAK) inhibitor, skin disease
- Medical subject headings
- Hidradenitis Suppurativa, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB054707Drug
Also called Povorcitinib
INCB054707 tablet administered orally once daily at the protocol-defined dose.
PlaceboDrug
Placebo tablet administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | INCB054707 at the Cohort 1 dose or placebo. Receives: Drug: INCB054707; Drug: Placebo |
| Cohort 2 | Experimental | INCB054707 at the Cohort 2 dose or placebo. Receives: Drug: INCB054707; Drug: Placebo |
| Cohort 3 | Experimental | INCB054707 at the Cohort 3 dose or placebo. Receives: Drug: INCB054707; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-emergent Adverse Events (TEAEs)
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".
Measured: Up to 12 weeks
Secondary outcomes (11)
Apparent Oral Clearance of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Measured: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Apparent Oral Volume of Distribution of INCB054707
To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
Measured: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
HiSCR defined as at least 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
Measured: Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
AN defined as abscess and inflammatory nodule count.
Measured: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
An 11-point scale used to assess the worst skin pain and the average skin pain due to HS. Skin pain ranges from 0 ("no skin pain") to 10 ("skin pain as bad as you can imagine").
Measured: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Modified Sartorius Scale Score
The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
Measured: From baseline up to week 8
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Measured: Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Proportion of Participants at Each Category of Hurley Stage
The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows:
Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring).
Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring).
Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
Measured: Baseline and Week 8
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.
Measured: Up to 12 weeks
Actual Measurements in HS-PGIC at Each Visit
The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area. The participant will answer the following: Since your last visit, your HS is: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.
Measured: Up to 12 weeks
Proportion of Participants With Change From Baseline Hurley Stage
The Hurley classification is a static score and was originally designed for selection of the appropriate treatment modality in a certain body region. The assessor determines the Hurley stage in each affected anatomical region. If more than 1 stage is present in the same region, the worst stage in that region is documented. The participant will be assigned an overall Hurley stage classification corresponding to the stage of the worst involved anatomical region. The definition of each Hurley stage is as follows:
Stage I : Abscess formation, single or multiple, without sinus tracts and cicatrization (scarring).
Stage II : One or more widely separated recurrent abscesses with tract formation and cicatrization (scarring).
Stage III : Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start15 Oct 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Butler, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607487
- Sponsor's protocol ID
- INCB 54707-203
- Other IDs
- 2018-000827-15, 2018
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2018
- Last updated
- 21 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6.
PubMed 34978076
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03607487
- Acronym / sponsor ID
- INCB 54707-203
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, Janus kinase (JAK) inhibitor, skin disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 21 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of INCB054707 over an 8-week treatment period in men and women with moderate to severe hidradenitis suppurativa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INCB054707, Drug: PlaceboINCB054707 at the Cohort 1 dose or placebo. |
| Cohort 2 | Experimental | Drug: INCB054707, Drug: PlaceboINCB054707 at the Cohort 2 dose or placebo. |
| Cohort 3 | Experimental | Drug: INCB054707, Drug: PlaceboINCB054707 at the Cohort 3 dose or placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
- Stable course of HS for at least 90 days before screening, as determined by the investigator.
- HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II or Hurley Stage III at screening.
- Total AN count of at least 3 at screening and baseline.
- Willingness to avoid pregnancy or fathering children.
Key exclusion criteria (13 listed)
- Women who are currently pregnant or lactating.
- Presence of > 20 draining fistulas at screening and baseline.
- Participants with protocol-defined concurrent conditions or history of other diseases.
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- Positive test result for tuberculosis from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening.
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: PovorcitinibINCB054707 tablet administered orally once daily at the protocol-defined dose. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo tablet administered orally once daily. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 12 weeks
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Grading was performed using guidance from the CTCAE v 4.03. A grade 3 and above would constitute as "severe".
11 secondary outcomes
Apparent Oral Clearance of INCB054707
Time frame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Apparent Oral Volume of Distribution of INCB054707
Time frame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8
Proportion of Participants Achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Time frame: Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Time frame: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Hidradenitis Suppurativa Pain Numeric Rating Scale (HS Pain NRS) Scores at Each Visit
Time frame: Baseline,Weeks 1, 2, 4, 6, 8, Early Termination and Follow-up (Up to 3 months)
Mean Change From Baseline in the Modified Sartorius Scale Score
Time frame: From baseline up to week 8
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit.
Time frame: Baseline,Weeks 1, 2, 4, 6, 8 and Follow-up (Up to 3 months)
Proportion of Participants at Each Category of Hurley Stage
Time frame: Baseline and Week 8
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period
Time frame: Up to 12 weeks
Actual Measurements in HS-PGIC at Each Visit
Time frame: Up to 12 weeks
Proportion of Participants With Change From Baseline Hurley Stage
Time frame: Baseline and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34978076Alavi A, Hamzavi I, Brown K, Santos LL, Zhu Z, Liu H, Howell MD, Kirby JS. Janus kinase 1 inhibitor INCB054707 for patients with moderate-to-severe hidradenitis suppurativa: results from two phase II studies. Br J Dermatol. 2022 May;186(5):803-813. doi: 10.1111/bjd.20969. Epub 2022 Mar 6.
- Individual participant dataSharing planned: No
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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.
Kathleen Butler, MD study director
Incyte Corporation
13 sites in 3 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, run by Incyte Corporation at 13 sites in 3 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 5 inclusion and 13 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 21 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 13 sites in Canada, Denmark, Germany. 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. 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 21 Sep 2020). 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?
Number of Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607487, which also lists 1 linked publication.
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 21 Aug 2025.