Hidradenitis SuppurativaPhase 2NCT03569371
A 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 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS). 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?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jul 2018to 22 Apr 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 III at screening and baseline.
- Total AN count of at least 3 at screening and baseline.
- Male participants must agree to use contraception per protocol-defined criteria.
Who cannot join
- Women of childbearing potential or who are currently pregnant or lactating.
- Presence of > 20 draining fistulas at screening and baseline.
- Participants with concurrent conditions or history of other diseases as follows:
- Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
- Active systemic viral infection or any active viral infection that, based on the investigator's clinical assessment, make the participant an unsuitable candidate for the study.
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- Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
- History of malignancy, including lymphoma and leukemia within 5 years before baseline, other than a successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- Albinism.
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
- Positive serology test results for HIV, HBsAg, hepatitis B virus (HBV) core antibody, or HCV (HCV antibody with positive HCV-RNA) at screening.
- Decreased blood cell counts at screening as per protocol-defined parameters.
- Severely impaired liver function (Child-Pugh Class C) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 1.5 × upper limit of normal (ULN).
- Impaired renal function with serum creatinine > 1.5 mg/dL.
- Use of prohibited medications per protocol-defined criteria.
- 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 prior to baseline.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Investigative Site
Hershey, Pennsylvania, 17033
Investigative Site
Los Angeles, California, 90045
Investigative Site
New York, New York, 10065
Investigative Site
Tampa, Florida, 33624
About this study
Official title: A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- INCB054707
- Keywords
- Hidradenitis suppurativa (HS), Janus kinase (JAK), Janus kinase 1 (JAK1) inhibitor
- 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
INCB054707 administered once daily orally with water without regard to food for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| INCB054707 | Experimental | Not described Receives: Drug: INCB054707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Up to approximately 12 weeks.
Secondary outcomes (15)
Apparent Oral Clearance of INCB054707(CL/F)
To evaluate the systemic exposure to INCB054707.
Measured: Postdose Day1, week 2 and 6
Apparent Oral Volume of Distribution of INCB054707(Vc/F)
To evaluate the systemic exposure to INCB054707.
Measured: Postdose Day1, week 2 and 6.
Absorption Constant of INCB054707 (Ka)
Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
Measured: Postdose Day1, week 2 and 6.
Apparent Inter-compartmental Clearance(Q/F)
Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
Measured: Postdose Day1, week 2 and 6.
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
An HiSCR is 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 at each visit.
Measured: Weeks 1,2,4,6,8 and FollowUp
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively.
Measured: Weeks 1,2,4,6,8 and FollowUp
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
The HS Pain NRS will be completed in a daily diary by participants from screening through EOS. An 11-point scale will be used to assess the worst skin pain due to HS based on a recall period of the last 24 hours. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine)
Measured: Weeks 1,2,4,6,8 and FollowUp
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: Week 8.
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Draining fistulas are fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
Measured: Up to approximately 12 weeks.
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.
Proportion of Participants With Change From Baseline to Week 8 in 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: Week 8.
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
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 approximately 12 weeks.
Proportion of Participants Requiring Rescue Lesional Treatment
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Measured: Up to approximately 12 weeks.
Number of Interventions With Rescue Lesional Treatment
Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
Measured: Up to approximately 12 weeks.
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The meaning of DLQI scores can be categorized as follows: 0-1 = No effect at all on patient's life 2-5 = Small effect on patient's life 6-10 = Moderate effect on patient's life 11-20 = Very large effect on patient's life 21-30 = Extremely large effect on patient's life
Measured: Up to approximately 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start17 Jul 2018
- Primary completion22 Apr 2019
- Study completion22 Apr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03569371
- Sponsor's protocol ID
- INCB 54707-202
- Status last verified
- Sep 2022
- First submitted
- 24 May 2018
- Last updated
- 26 Sep 2022
- 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03569371
- Acronym / sponsor ID
- INCB 54707-202
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa (HS), Janus kinase (JAK), Janus kinase 1 (JAK1) inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 20 May 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 assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB054707 | Experimental | Drug: INCB054707 |
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 III at screening and baseline.
- Total AN count of at least 3 at screening and baseline.
- Male participants must agree to use contraception per protocol-defined criteria.
Key exclusion criteria (19 listed)
- Women of childbearing potential or who are currently pregnant or lactating.
- Presence of > 20 draining fistulas at screening and baseline.
- Participants with concurrent conditions or history of other diseases as follows:
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
- Positive test result for tuberculosis (TB) from the QuantiFERON-TB Gold test, or equivalent, at screening (or, if 2 indeterminate tests or not available, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening) or a history of active TB.
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 administered once daily orally with water without regard to food for 8 weeks. | Drug | INCB054707 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 12 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.
15 secondary outcomes
Apparent Oral Clearance of INCB054707(CL/F)
Time frame: Postdose Day1, week 2 and 6
Apparent Oral Volume of Distribution of INCB054707(Vc/F)
Time frame: Postdose Day1, week 2 and 6.
Absorption Constant of INCB054707 (Ka)
Time frame: Postdose Day1, week 2 and 6.
Apparent Inter-compartmental Clearance(Q/F)
Time frame: Postdose Day1, week 2 and 6.
Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit
Time frame: Weeks 1,2,4,6,8 and FollowUp
Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit
Time frame: Weeks 1,2,4,6,8 and FollowUp
Mean Change From Baseline in the HS Pain Numeric Rating Scale (NRS) Scores at Each Visit
Time frame: Weeks 1,2,4,6,8 and FollowUp
Mean Change From Baseline in the Modified Sartorius Scale Score
Time frame: Week 8.
Mean Change From Baseline in the Number of Draining Fistulas Count at Each Visit
Time frame: Up to approximately 12 weeks.
Proportion of Participants at Each Category of Hurley Stage
Time frame: Baseline and Week 8.
Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage
Time frame: Week 8.
Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category
Time frame: Up to approximately 12 weeks.
Proportion of Participants Requiring Rescue Lesional Treatment
Time frame: Up to approximately 12 weeks.
Number of Interventions With Rescue Lesional Treatment
Time frame: Up to approximately 12 weeks.
Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit
Time frame: Up to approximately 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- 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
4 sites in 1 country: 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 4 sites in United States.
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 19 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 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 20 May 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 Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 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 NCT03569371, 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 26 Sep 2022.