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    Summary
    EudraCT Number:2021-000271-36
    Sponsor's Protocol Code Number:KKS288
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-000271-36
    A.3Full title of the trial
    Guselkumab in Patients with Oral Lichen Planus - An open label, parallel, randomized, multi- center, phase II trial
    Guselkumab in Patienten mit oralem Lichen-Planus – Eine offene, parallele, randomisierte, multizentrische Phase II Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy with the bioactive substance Guselkumab in patients suffering from oral skin disease Lichen-Planus using an open-label, parallel, multi-center phase IIa trial design
    A.4.1Sponsor's protocol code numberKKS288
    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 SponsorPhilipps University Marburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKoordinierungszentrum für Klinische Studien (KKS) Marburg
    B.5.2Functional name of contact pointNelli Ens-Jäger
    B.5.3 Address:
    B.5.3.1Street AddressKarl-von-Frisch-Straße 4
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35043
    B.5.3.4CountryGermany
    B.5.4Telephone number+4915114980915
    B.5.5Fax number+4964212866517
    B.5.6E-mailnelli.ens@kks.uni-marburg.de
    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 Yes
    D.2.1.1.1Trade name Tremfya
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGuselkumab
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    severe oral lichen planus (LP) with variable phenotype (erosive, ulcerating, hyperplastic/leucoplastic, and combined forms)
    E.1.1.1Medical condition in easily understood language
    severe oral skin disease lichen planus (LP) with variable outer appearance
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10030983
    E.1.2Term Oral lichen planus
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of Guselkumab treatment on mucosal T-cell infiltration 12 weeks after study entry in patients with oral lichen planus (LP) with different phenotypes (erosive, ulcerative, hyperplastic / leukoplastic and combined forms)
    E.2.2Secondary objectives of the trial
    Pharmacodynamics, Association between the mechanistical responders/ improvement and the clinical improvement, Quality of Life, Safety, immunological read outs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent form
    2. Capability and willingness to comply with study procedures
    3. Adult patients ≥ 18 years
    4. Moderate to severe Oral LP with variable phenotype (erosive, ulcerating, hyperplastic/leukoplakic, and combined forms and other side manifestations like skin manifestations)
    5. Oral involvement ≥ 3 month
    6. Escudier-Score ≥ 10
    7. Histology characteristic for LP
    8. Refractory to topical therapy with high-potency glucocorticoids (group I, II, III as per WHO definition)
    9. For women of child-bearing potential: a negative result in a pregnancy test AND agreement to practice a highly effective method of contraception during the entire period from informed consent up to 90 days after the last administration of the IMP.
    10. For non-sterilised males who are sexually active with a female partner of child-bearing potential: Agreement to practice highly effective methods of contraception during the entire period from first study intervention up to 90 days after the last administration of the IMP
    E.4Principal exclusion criteria
    1. 1. Subjects with either a chronic infection, a prior history of recurrent infection, or a clinically important active infection (e.g. active tuberculosis) should not be administered Guselkumab.
    2. History of latent tuberculosis
    3. Patients with clinical relevant illnesses (e.g. severe renal, heart and/ or liver insufficiency, malignancies) and clinical relevant changes in lab parameter (e.g. WBC, absolute neutrophile count, hemoglobin, AST/ALT, bilirubin)
    4. History of any malignancy or obligatory precancerous condition of any organ system other than cervical carcinoma of Stage 1B or less, or non-invasive basal cell carcinoma of the skin in the last 5 years before IMP administration
    5. Patients tested positive for hepatitis B virus (HBV) infection, hepatitis C virus (HCV) or human immunodeficiency viruses (HIV)
    6. Systemic/topical glucocorticoids of high - ultrahigh potency (group I, II, III as per WHO definition) within 4 weeks days prior to treatment*
    7. Severe hypersensitivity, intolerance or allergy against Guselkumab, to human immunoglobulin (Ig) proteins, mAbs, or antibody fragments
    8. Live or inactive vaccine within the 28 days before first study treatment, or a planned vaccination during the study. NOTE: SARS-CoV2 and influenza vaccinations may be performed at the earliest 28 days before or after the last IMP treatment
    9. Breastfeeding
    10. Concomitant therapy with immunosuppressive drugs, biologics or phototherapy
    11. Patients with an increased risk of respiratory infections (e.g. patients with chronic obstructive pulmonary disease)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients who experience a 50% reduction in the relative number (of total CD3+ T cells) of IL-17+ CD4+ and IL-17+ CD8+ T cells in mucosal biopsies at week 12 compared to week 0 (pre-treatment). For the sake of simplicity, these patients will be called “responders” in the statistical section.
    The responder rates will be compared between the two groups (waiting list and verum)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    1) Pharmcodynamics
    2)Association between the mechanistical responders/ improvement and the clinical improvement
    3)Quality of Life
    4)Safety
    Immunolgical read-outs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Pharmacodynamics of Guselkumab in patients with oral LP (Week 0 vs. 12 and 24)
    2. Association between the mechanistical responders/ improvement and the clinical improvement (comparison week 12 and 24)
    3. Quality of Life (Patient reported Outcomes) in patients with oral LP treated with Guselkumab (Weeks 0, 4, 12, 20, 24)
    4. Safety (throughout study)
    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 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
    Quality of Life, Imunolgical readouts: T cell subpopulations (e.g. CD4, CD8, IFN-γ, IL-17) within lesional biopsies; peripheral blood T cell subpopulations (e.g. Th1-, Th17-cells), safety
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Waiting list design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state45
    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)
    Treatment after termination (premature or regular) of the study will be decided individually between the investigators and the patients
    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 Decision2021-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-20
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