A Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
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| ClinicalTrials.gov Identifier: NCT03607487 |
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Recruitment Status :
Completed
First Posted : July 31, 2018
Results First Posted : September 21, 2020
Last Update Posted : September 26, 2022
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hidradenitis Suppurativa | Drug: INCB054707 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa |
| Actual Study Start Date : | October 15, 2018 |
| Actual Primary Completion Date : | August 13, 2019 |
| Actual Study Completion Date : | August 13, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hidradenitis suppurativa
MedlinePlus related topics:
Hidradenitis Suppurativa
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1
INCB054707 at the Cohort 1 dose or placebo.
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Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Other Name: Povorcitinib Drug: Placebo Placebo tablet administered orally once daily. |
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Experimental: Cohort 2
INCB054707 at the Cohort 2 dose or placebo.
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Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Other Name: Povorcitinib Drug: Placebo Placebo tablet administered orally once daily. |
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Experimental: Cohort 3
INCB054707 at the Cohort 3 dose or placebo.
|
Drug: INCB054707
INCB054707 tablet administered orally once daily at the protocol-defined dose.
Other Name: Povorcitinib Drug: Placebo Placebo tablet administered orally once daily. |
Primary Outcome Measures :
- 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".
Secondary Outcome Measures :
- Apparent Oral Clearance of INCB054707 [ Time Frame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 ]To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
- Apparent Oral Volume of Distribution of INCB054707 [ Time Frame: Predose Day 1, Week 4, and 8, Postdose Day1, week 2,4,6, and 8 ]To determine the systemic exposure to INCB054707. Dependent upon the final compartmental model describing INCB054707.
- 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) ]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.
- 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) ]AN defined as abscess and inflammatory nodule count.
- 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) ]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").
- Mean Change From Baseline in the Modified Sartorius Scale Score [ Time Frame: From baseline up to week 8 ]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.
- 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) ]Defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.
- Proportion of Participants at Each Category of Hurley Stage [ Time Frame: Baseline and Week 8 ]
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.
- Proportions of Participants in Each HS Patient Global Impression of Change (PGIC) Category During the Treatment Period [ Time Frame: Up to 12 weeks ]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.
- Actual Measurements in HS-PGIC at Each Visit [ Time Frame: Up to 12 weeks ]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.
- Proportion of Participants With Change From Baseline Hurley Stage [ Time Frame: Baseline and Week 8 ]
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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607487
Locations
| Canada, Manitoba | |
| Investigative Site | |
| Winnipeg, Manitoba, Canada, R3M 3Z4 | |
| Canada, New Brunswick | |
| Investigative Site | |
| Fredericton, New Brunswick, Canada, E3B 1G9 | |
| Canada, Ontario | |
| Investigative Site | |
| Barrie, Ontario, Canada, L4M 7G1 | |
| Investigative Site | |
| London, Ontario, Canada, N6H 5L5 | |
| Investigative Site 009 | |
| Markham, Ontario, Canada, L3P 1X2 | |
| Investigative Site 008 | |
| Richmond Hill, Ontario, Canada, L4C 9M7 | |
| Investigative Site 007 | |
| Windsor, Ontario, Canada, N8W 5L7 | |
| Canada, Quebec | |
| Investigative Site | |
| Drummondville, Quebec, Canada, J2B 5L4 | |
| Investigative Site | |
| St-Jerome, Quebec, Canada, J7Z 7E2 | |
| Denmark | |
| Investigative Site | |
| Aarhus, Denmark, 8200 | |
| Investigative Site | |
| Roskilde, Denmark, 4000 | |
| Germany | |
| Investigative Site | |
| Bochum, Noth Rhine-Westphalia, Germany, 44791 | |
| Investigative Site | |
| Lübeck, Schleswig-Holstein, Germany, 23538 | |
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Kathleen Butler, MD | Incyte Corporation |
Study Documents (Full-Text)
Documents provided by Incyte Corporation:
Documents provided by Incyte Corporation:
Study Protocol [PDF] August 9, 2018
Statistical Analysis Plan [PDF] March 1, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT03607487 |
| Other Study ID Numbers: |
INCB 54707-203 |
| First Posted: | July 31, 2018 Key Record Dates |
| Results First Posted: | September 21, 2020 |
| Last Update Posted: | September 26, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Incyte Corporation:
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Hidradenitis suppurativa Janus kinase (JAK) inhibitor skin disease |
Additional relevant MeSH terms:
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Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial |
Bacterial Infections Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Suppuration |