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    Summary
    EudraCT Number:2018-000827-15
    Sponsor's Protocol Code Number:INCB54707-203
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-09-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2018-000827-15
    A.3Full title of the trial
    A Phase 2, Dose-Escalation, Placebo-Controlled Study of the Safety
    of INCB054707 in Participants With Hidradenitis Suppurativa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study on Hidradenitis Suppurativa to investigate the safety of the Investigational Medicinal product INCB054707.
    A.4.1Sponsor's protocol code numberINCB54707-203
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03607487
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIncyte Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 302 498 5663
    B.5.5Fax number+1 302 425 2734
    B.5.6E-mailRA@incyte.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameINCB054707
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINCB054707
    D.3.9.2Current sponsor codeINCB054707
    D.3.9.3Other descriptive nameINCB054707
    D.3.9.4EV Substance CodeSUB193576
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis Suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis suppurativa, HS disease
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety and tolerability of
    INCB054707
    E.2.2Secondary objectives of the trial
    To determine the systemic exposure to INCB054707. To determine the efficacy of INCB054707. To assess the need for rescue lesional treatment. To assess patient-reported quality-of-life burden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged 18 to 75 years at the time of consent.
    2. Diagnosis of HS (confirmed by a dermatologist) with a disease duration of at least 6 months before screening.
    3. Stable course of HS for at least 90 days before screening, as determined by the investigator.
    4. HS lesions present in at least 2 distinct anatomic areas, 1 of which must be Hurley Stage II (ie, recurrent abscessed with tract formation and cicatrization; single or multiple, widely separated lesions) or Hurley Stage III (ie, diffuse or near diffuse involvement, or multiple interconnected tracts and abscesses across the entire area) at screening.
    5. Total AN count of at least 3 at screening and baseline.
    6. Willingness to avoid pregnancy or fathering children based on the criteria below:
    a. Male participants must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through 90 days after the last dose of study drug. Male participants must also refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and his understanding confirmed.
    b. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
    c. Women of nonchildbearing potential (ie, surgically sterile [hysterectomy, bilateral oophorectomy, or bilateral salpingectomy] OR postmenopausal, defined as ≥ 12 months of amenorrhea before screening without an alternative medical cause, confirmed by FSH levels at screening) are eligible.
    E.4Principal exclusion criteria
    1. Women who are currently pregnant or lactating.
    2. Presence of > 20 draining fistulas at screening and baseline.
    3. Participants with concurrent conditions or history of other diseases, as follows:
    a. Any clinically significant medical condition other than HS, as determined by the investigator, that is not adequately controlled with appropriate treatment.
    b. Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of HS.
    c. 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.
    d. Current herpes zoster infection, a history of recurrent herpes zoster, a history of disseminated herpes simplex, or a history of herpes zoster.
    e. History of or ongoing serious illness or medical, physical or psychiatric condition(s) that – in the investigator's opinion – would 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.
    f. Albinism.
    4. Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF), defined as ≥ 450 msec.
    Note: Prolonged QTcF values of ≥ 450 msec at screening are to be confirmed by performing 2 additional ECGs and averaging the results to determine whether the averaged value meets the exclusion criterion.
    5. Positive test result for TB from the QuantiFERON-TB Gold test, or T-SPOT.TB test at screening (or, if two indeterminate tests, then as evaluated by a purified protein derivative test with a result of < 5 mm of induration within 3 months of screening).
    6. A history of active TB (treated or untreated) or a history of untreated latent TB. Note: If the participant has possible evidence of a latent TB infection, the participant must have documented completion of an adequate course of therapy for latent TB and provide recent (within 3 months) posteroanterior and lateral view chest X-rays without
    changes suggestive of active or latent TB, before baseline.
    7. Positive serology test results for HIV, HBsAg, HBV core antibody, or HCV
    (HCV-antibody with positive HCV-RNA) at screening.
    8. Decreased blood cell counts at screening, defined as follows:
    a. Leukocytes < 3.0 × 109/L (< 2.5 × 109/L for participants who are African-American).
    b. ANC < 1.5 × 109/L.
    c. Lymphocytes < 0.8 × 109/L.
    d. Hemoglobin < 10 g/dL.
    e. Platelets < 150 × 109/L.
    9. Severely impaired liver function (Child-Pugh Class C) or ALT or AST levels
    ≥ 1.5 × ULN at screening.
    10. Impaired renal function with serum creatinine > 1.5 mg/dL at screening.
    11. Use of the following medications:
    a. Previous use of JAK inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, and pacritinib).
    b. Previous use of adalimumab or any other TNF-α treatment within 12 weeks or 5 half-lives (whichever is longer) before baseline.
    c. Use of any investigational or experimental treatments within 12 weeks or 5 half-lives (whichever is longer) before baseline.
    d. Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, and azathioprine) within 4 weeks or 5 half-lives (whichever is longer) before baseline.
    e. Other systemic therapies for HS (eg, retinoids and antiandrogens) with potential therapeutic impact for HS within 4 weeks or 5 half-lives (whichever is longer) before baseline.
    f. Surgical, laser, or IPL intervention in area with HS lesion within 4 weeks before baseline.
    g. Systemic anti-infectives (eg, antibiotics, antivirals, antifungals) within 4 weeks, except as described in Section 6.7.1.1 for antibiotic therapy, or topical anti-infectives on HS lesions (eg, antibiotics, antivirals, antifungals) within 2 weeks before baseline.
    h. Received live vaccine within 6 weeks before baseline or planning to receive live vaccine during the course of the study or within 6 weeks after EOT.
    i. Topical antiseptic washes, creams, soaps, ointments, gels, and liquids containing antibacterial agents to treat HS, except those listed in Sections 6.7.1.3 and 6.7.1.4, within 2 weeks before baseline.
    j. Potent systemic CYP3A4 inhibitors and inducers (see Study Manual) or fluconazole within 2 weeks or 5 half-lives (whichever is longer) before baseline. Note: Topical agents with limited systemic availability are permitted.
    12. Known or suspected allergy to INCB054707 or any component of the study drug.
    13. Known history of clinically significant drug or alcohol abuse in the last year before baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency, duration, and severity of AEs, clinical
    laboratory test results, vital signs results, ECGs,
    and physical examination findings.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs: at each visit
    clinical laboratory tests: at each visit
    vital signs: at each visit
    ECGs: at screening, Day 1, Week 4, week 8.
    physical examination: at screening and Week 8.
    E.5.2Secondary end point(s)
    -Population PK parameters of INCB054707.
    -Proportion of participants achieving a HiSCR at
    each visit.
    -Proportion of participants achieving an AN count
    of 0 to 2 at each visit.
    -Mean change from baseline in the HS Pain NRS
    scores, worst and average pain, at each visit.
    -Mean change from baseline to Week 8 in the
    modified Sartorius scale score.
    -Mean change from baseline in the number of
    draining fistulas count at each visit.
    -Proportion of participants at each category of
    Hurley Stage at baseline and Week 8.
    -Proportion of participants with change from
    baseline in Hurley Stage at Week 8.
    -Proportions of participants in each HS-PGIC
    category during the treatment period.
    -Actual measurements in HS-PGIC at each visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Day 1, Week 2, Week 4, Week 6, Week 8.
    HiSCR, AN count: at each visit
    HS pain NRS: at each visit
    Sartorius scale score: Day 1, Week 8 and at follow-up
    Fistulas count: at each visit
    Hurley stage: at screening, Week 8 and at follow-up
    HS-PGIC: At week 1,2,4,6,8 and at follow-up
    Rescue lesional treatment: Week 1,2,4,6,8 and at follow-up
    DLQI: at each visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No plans after for treatment after the study. The study subjects will receive the expected normal treatment on HS.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-13
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