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A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569371
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : May 20, 2020
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE May 24, 2018
First Posted Date  ICMJE June 26, 2018
Results First Submitted Date  ICMJE April 22, 2020
Results First Posted Date  ICMJE May 20, 2020
Last Update Posted Date September 26, 2022
Actual Study Start Date  ICMJE July 17, 2018
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
Number of 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • Apparent Oral Clearance of INCB054707(CL/F) [ Time Frame: Postdose Day1, week 2 and 6 ]
    To evaluate the systemic exposure to INCB054707.
  • Apparent Oral Volume of Distribution of INCB054707(Vc/F) [ Time Frame: Postdose Day1, week 2 and 6. ]
    To evaluate the systemic exposure to INCB054707.
  • Absorption Constant of INCB054707 (Ka) [ Time Frame: Postdose Day1, week 2 and 6. ]
    Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
  • Apparent Inter-compartmental Clearance(Q/F) [ Time Frame: Postdose Day1, week 2 and 6. ]
    Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
  • Proportion of Participants With a Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit [ Time Frame: Weeks 1,2,4,6,8 and FollowUp ]
    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.
  • Proportion of Participants Achieving an AN Count of 0 to 2 at Each Visit [ Time Frame: Weeks 1,2,4,6,8 and FollowUp ]
    The number and proportion of participants who achieved an Abscess and Inflammatory nodule count of 0 to 2 progressively.
  • 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 ]
    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)
  • Mean Change From Baseline in the Modified Sartorius Scale Score [ Time Frame: 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: Up to approximately 12 weeks. ]
    Draining fistulas are 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.
  • Proportion of Participants With Change From Baseline to Week 8 in Hurley Stage [ Time Frame: 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 [ Time Frame: Up to approximately 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 Requiring Rescue Lesional Treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
  • Number of Interventions With Rescue Lesional Treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
  • Proportion of Participants at Each Scoring Category of the Dermatology Life Quality Index (DLQI) at Each Visit [ Time Frame: Up to approximately 12 weeks. ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2018)
  • Apparent oral clearance of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    To evaluate the systemic exposure to INCB054707.
  • Apparent oral volume of distribution of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    To evaluate the systemic exposure to INCB054707.
  • Absorption constant of INCB054707 [ Time Frame: Up to approximately 6 weeks. ]
    Other population pharmacokinetic (PK) model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
  • Apparent inter-compartmental clearance [ Time Frame: Up to approximately 6 weeks. ]
    Other population PK model parameter that the PK model may include to evaluate the systemic exposure to INCB054707.
  • Proportion of participants with a hidradenitis suppurativa clinical response (HiSCR) at each visit [ Time Frame: Up to approximately 12 weeks. ]
    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.
  • Proportion of participants achieving an AN count of 0 to 2 at each visit [ Time Frame: Up to approximately 12 weeks. ]
    Abscess and inflammatory nodule count.
  • Mean change from baseline in the HS Pain Numeric Rating Scale (NRS) scores at each visit [ Time Frame: Up to approximately 12 weeks. ]
    The HS Pain NRS is an 11-point scale used to assess the worst skin pain and the average skin pain due to HS.
  • Mean change from baseline in the modified Sartorius scale score [ Time Frame: Week 8. ]
    The modified Sartorius scale is a measure of the severity of HS with points given for each body area. The total modified Sartorius scale score is the sum of the 12 anatomic region scores.
  • Mean change from baseline in the number of draining fistulas count at each visit [ Time Frame: Up to approximately 12 weeks. ]
    Draining fistulas are 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. ]
    Investigator-determined Hurley Stage (I, II, or III, corresponding with the Hurley Stage of worst involved anatomic region).
  • Proportion of participants with change from baseline in Hurley Stage [ Time Frame: Week 8. ]
    Investigator-determined Hurley Stage (I, II, or III, corresponding with the Hurley Stage of worst involved anatomic region).
  • Proportions of participants in each HS Patient Global Impression of Change (PGIC) category [ Time Frame: Up to approximately 12 weeks. ]
    The HS-PGIC consists of 1 self-administered item that assesses change in the severity of skin in the HS area.
  • Proportion of participants requiring rescue lesional treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
  • Number of interventions with rescue lesional treatment [ Time Frame: Up to approximately 12 weeks. ]
    Rescue lesional treatment is defined as immediate intervention in the event of an acutely painful lesion.
  • Proportion of participants at each scoring category of the Dermatology Life Quality Index (DLQI) at each visit [ Time Frame: Up to approximately 12 weeks. ]
    The DLQI is a questionnaire used to assess the symptoms and the impact of skin problems on quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Official Title  ICMJE A Phase 2, Open-Label, Single-Arm Study of the Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Brief Summary The purpose of this study is to assess the safety of INCB054707 in men and women with moderate to severe hidradenitis suppurativa (HS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Drug: INCB054707
INCB054707 administered once daily orally with water without regard to food for 8 weeks.
Other Name: Povorcitinib
Study Arms  ICMJE Experimental: INCB054707
Intervention: Drug: INCB054707
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 22, 2019
Actual Primary Completion Date April 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

Exclusion Criteria:

  • 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.
    • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569371
Other Study ID Numbers  ICMJE INCB 54707-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Incyte Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Incyte Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kathleen Butler, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP