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    Summary
    EudraCT Number:2020-004198-38
    Sponsor's Protocol Code Number:KPL-716-C201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-01
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004198-38
    A.3Full title of the trial
    KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis
    A.4.1Sponsor's protocol code numberKPL-716-C201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03816891
    A.5.4Other Identifiers
    Name:INDNumber:132912
    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 SponsorKiniksa Pharmaceuticals, Ltd.
    B.1.3.4CountryBermuda
    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 supportKiniksa Pharmaceuticals, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKiniksa Pharmaceuticals, Ltd.
    B.5.2Functional name of contact pointJordan Esraelian
    B.5.3 Address:
    B.5.3.1Street Address9191 Towne Centre Drive, Suite 330
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92122
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17816229564
    B.5.6E-mailjesraelian@Kiniksa.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 nameVIXARELIMAB
    D.3.2Product code KPL-716
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVixarelimab
    D.3.9.3Other descriptive nameHuman IgG4-G1 monoclonal antibody against OSMR
    D.3.9.4EV Substance CodeSUB218816
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pruritus in Subjects with Prurigo Nodularis
    E.1.1.1Medical condition in easily understood language
    Chronic itchy skin in subjects with Prurigo Nodularis, a skin condition that causes hard, itchy lumps (nodules) to form on the skin.
    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 10037084
    E.1.2Term Prurigo nodularis
    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 evaluate the efficacy of subcutaneous (SC) KPL-716 vs. placebo in reducing pruritus in PN subjects experiencing severe pruritus
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of SC KPL-716 vs. placebo in improving sleep in PN subjects experiencing severe pruritus
    • To evaluate the effect of SC KPL-716 vs. placebo in improving quality of life in PN subjects experiencing severe pruritus
    • To evaluate the effect of SC KPL-716 vs. placebo in reducing disease severity in PN subjects experiencing severe pruritus
    • To evaluate the safety and tolerability of SC KPL-716 vs. placebo in PN subjects experiencing severe pruritus
    • To evaluate the pharmacokinetics (PK) of SC KPL-716 in PN subjects experiencing severe pruritus
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged 18 to 80 years, inclusive, at the time of consent.
    2. Have a physician-documented diagnosis of PN that is confirmed by review of medical photography (as outlined in the Study Manual) during the Screening Period. Duration of PN (since the time of first PN nodule) must be at least 6 months from the time of first PN nodule to Day 1, as affirmed by the subject.
    3. Have at least 20 nodules of approximately 0.5 to 2 cm at the Screening Visit and Day 1. The nodules must be pruritic and present on at least 2 different anatomical locations (not be localized), involve the extremities, with extensor extremity involvement greater than the flexor extremity involvement. Nodules on the head (face and scalp) are not counted as an anatomical location for eligibility criteria. Each arm, each leg, and trunk are considered different anatomical locations.
    4. Subject has severe pruritus, defined as WI-NRS ≥7 at the Screening Visit and a mean weekly WI-NRS ≥7 for the week (7 consecutive days) immediately prior to randomization (at least 5 days of recordings) on eDiary.
    5. PN-IGA score of ≥3 (on a scale of 0-4, in which 3 is moderate and 4 is severe) at Screening and Baseline Visits
    6. Sexually active female subjects must be:
    • postmenopausal, defined as at least 12 consecutive months post cessation of menses (without an alternative medical cause) and confirmed by a follicular stimulating hormone (FSH) test, or
    • surgically sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy or
    • nonpregnant, nonlactating, and having agreed to use a highly effective method of contraception from the Screening Visit until 16 weeks after final study drug administration.
    7. Sexually active male subjects must have documented vasectomy or must agree to use a highly effective method of contraception as defined above with their partners of childbearing potential from first dose until 16 weeks after final study drug administration.
    8. Male subjects must agree to refrain from donating sperm from first dose until 16 weeks after the last study drug administration. Female subjects must agree to refrain from donating eggs from first dose until 16 weeks after the last study drug administration.
    9. Female of childbearing potential must have a negative serum β-hCG test at the Screening Visit and negative urine pregnancy test on Day 1.
    10. Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study.
    11. Subjects must be on optimized and stable treatment for co-morbidities for at least 28 days prior to Day 1.
    E.4Principal exclusion criteria
    1. Use of the following medications within the indicated timeframe prior to Day 1 and does not agree to refrain from the use of the medications throughout the study (except those specified in the Pharmacy Manual):
    a. Systemic corticosteroids (IV/IM/oral): 4 weeks; Note: Intranasal corticosteroids, eye drops containing corticosteroids, and inhaled corticosteroids for stable medical conditions are allowed.
    b. Intralesional corticosteroids and intra-articular corticosteroids: 6 weeks
    c. Topical treatments for PN including but not limited to corticosteroids, calcineurin inhibitors, phosphodiesterase inhibitors, retinoids, calcipotriol, capsaicin, camphor, polidocanol, cannabinoids, gabapentin, or tars: 2 weeks
    d. Antihistamines: 2 weeks
    e. Immunomodulators (for example, cyclosporin, methotrexate, retinoids, azathioprine, mycophenolate, and thalidomide): 4 weeks
    f. Neuroactive drugs such as gabapentin and pregabalin: 4 weeks
    g. Cannabinoids: 2 weeks
    h. Opioid antagonists or agonists: 5 half-lives if known or 4 weeks
    i. Janus kinase inhibitors: 5 half-lives if known or 4 weeks
    j. Dupilumab: 8 weeks
    k. Any other marketed biologic: 5 half-lives or within 4 months of using rituximab
    l. Any investigational drug: 5 half-lives
    m. Phototherapy involving UVA, UVB, or excimer: 4 weeks
    n. Tanning salon use: 4 weeks
    o. Live attenuated vaccine: 12 weeks
    2. Has received any investigational biologic or non-biologic drug that targets Oncostatin M, IL-31, IL-31 receptor α, or Oncostatin M receptor β in the past 3 months.
    3. Required rescue therapy for PN during the Screening Period or expected to require rescue therapy within 4 weeks following the Baseline Visit.
    4. Has a significant exacerbation and/or skin eruption during the Screening Period (prior to the study drug administration) that requires medical intervention.
    5. Presence of scabies, insect bite, lichen simplex chronicus, psoriasis, acne, folliculitis, habitual picking, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, and/or skin condition other than PN or atopic dermatitis unless approved by the Sponsor.
    6. Plan to change emollients or moisturizers, or to have bath oil treatment for relief of pruritus during the course of the trial.
    7. Presence of psychogenic pruritus or neuropathic pruritus at the Screening Visit.
    8. Presence of moderately severe depression as indicated by PHQ-9 total score of ≥15 or item 9 score >0 at the Screening Visit or Day 1.
    9. Presence of severe anxiety as indicated by GAD-7 score of ≥15 at the Screening Visit or Day 1.
    10. Presence of severe chronic pain (e.g., back pain, migraine, osteoarthritis, etc., defined as ≥7.0 on 0 to 10 NRS scale with 0 being no pain and 10 being the worst pain possible) at the Screening Visit.
    11. Presence of uncontrolled hyperthyroidism or hypothyroidism or uncontrolled diabetes defined as hemoglobin A1c >7.5%.
    12. Presence or history of cancer or lymphoproliferative disease within 5 years prior to the Screening Visit, with the exception of basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix successfully treated and considered controlled.
    13. Presence or history of immune deficiency, or opportunistic infections.
    14. Positive results for hepatitis B surface antigen (HbsAg) and/or hepatitis B anti-core antibody (anti-HBc) but negative results for anti-surface antibody (anti-HBs) at the Screening Visit.
    15. Positive results for hepatitis C antibody unless patient received curative therapy and a negative viral load is documented.
    16. Human immunodeficiency virus (HIV) infection or positive HIV serology at the Screening Visit.
    17. Positive COVID-19 viral test at the Screening Visit or suspected COVID-19 infection at the Baseline Visit.
    18. Subject is on hemodialysis or peritoneal dialysis.
    19. Latent or active TB, as determined by a positive Quantiferon-based TB test result at the Screening visit.
    20. Laboratory abnormalities that fall outside the windows below at the Screening Visit (see Protocol).
    21. Major surgery within 12 weeks prior to Day 1 or has a major surgery planned during the study.
    22. Has an active infection, including skin infection, requiring systemic treatment within 4 weeks and/or topical treatment within 2 weeks of Day 1. Subject has an active or chronic parasitic infection.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in weekly average Worst Itch–Numeric Rating Scale (WI-NRS) at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 (end of double-blind period).
    E.5.2Secondary end point(s)
    • Proportion of subjects achieving at least a 6-point reduction from baseline in weekly average WI-NRS at Week 16
    • Proportion of subjects achieving at least a 4-point reduction from baseline in weekly average WI-NRS at Week 16
    • Proportion of subjects achieving 0 or 1 from baseline in PN-IGA at Week 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 (end of double-blind period).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Australia
    Canada
    Korea, Republic of
    Taiwan
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Poland
    United Kingdom
    Czechia
    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
    LVLS
    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 months1
    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 months1
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 180
    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)
    None.
    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 Decision2021-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-24
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