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    Summary
    EudraCT Number:2021-006031-25
    Sponsor's Protocol Code Number:UPALI
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-05
    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 - BfArM
    A.2EudraCT number2021-006031-25
    A.3Full title of the trial
    Treatment of patients with Lichen planus with the JAK-Inhibitor Upadacitinib (Rinvoq®) – a mono-centered double-blinded placebo controlled randomized pilot study (investigator-initiated trial)
    Behandlung von Patienten mit Lichen planus mit dem JAK-Inhibitor Upadacitinib - eine monozentrische, doppelblinde, plazebokontrollierte, randomisierte Pilotstudie (IIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of a new treatment strategy for patients with the severe skin disease Lichen planus
    Untersuchung einer neuen Behandlungsstrategie für Patienten mit der schweren Hauterkrankung Lichen planus
    A.4.1Sponsor's protocol code numberUPALI
    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 SponsorCharité - Universitätsmedizin Berlin
    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 supportAbbvie
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointAllergy Center Charité
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.6E-mailacc-studien@charite.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 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 nameUpadacitinib
    D.3.4Pharmaceutical form Prolonged-release 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 INNUpadacitinib
    D.3.9.3Other descriptive nameRINVOQ
    D.3.9.4EV Substance CodeSUB187251
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase Inhibitor
    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 placeboFilm-coated tablet
    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
    Patients with the chronic inflammatory skin disease Lichen planus will be treated with the JAK inhibitor upadacitinib.
    Patienten, die an der chronisch inflammatorischen Hauterkrankung Lichen planus leiden, werden mit dem JAK Inhibitor Upadacitinib behandelt.
    E.1.1.1Medical condition in easily understood language
    Patients with a skin disease (Lichen planus) will be treated with a substance that reduces the action of the immune system
    Patienten mit einer Hauterkrankung (Lichen planus) werden mit einer Substanz behandelt, die die Aktivität des Immunsystems reduziert.
    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
    To evaluate the efficacy of upadacitinib (Rinvoq®) therapy in patients with Lichen planus.
    Bewertung der Immunantwort, Wirksamkeit und Sicherheit von Upadacitinib (Rinvoq®) Behandlung bei Patienten mit Lichen planus.
    E.2.2Secondary objectives of the trial
    To evaluate the immunological response and safety of upadacitinib (Rinvoq®) therapy in patients with Lichen planus.
    Bewertung der Immunantwort und Sicherheit von Upadacitinib (Rinvoq®) Behandlung bei Patienten mit Lichen planus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with diagnosis of acute or chronic (>3 months) Lichen planus and with a clinical presentation and histopathology consistent (performed within 6 months prior to screening) with Lichen planus.
    2. Patients with moderate to severe disease and Investigator Global Assessment (IGA) score ≥ 3 (scale of 0 to 4) at screening and baseline visit.
    3. Patient with involvement of the oral cavity (with at least one target lesion of oral lichen planus).
    4. Male or female patient aged 18 to 65 years old.
    5. Patients with body weight ≥ 40 kg and ≤ 120 kg.
    1. Patienten mit einem diagnostizierten akuten oder chronischen Lichen planus (>3 Monate), histopathologisch mit Lichen planus übereinstimmend (innerhalb 6 Monate vor dem Screening).
    2. Patienten mit moderater bis schwerer Erkrankung und einer IGA (Investigators global assessment) Punktzahl von ≥ 3 (Skala 0-4) bei Screening und Baseline Visite.
    3. Patienten, bei denen die Mundhöhle betroffen ist (mindestens eine Zielläsion von oralem Lichen planus).
    4. Männliche oder weibliche Patienten im Alter von 18 bis 65 Jahren
    5. Patienten mit einem Körpergewicht zwischen ≥ 40 kg und ≤ 120 kg.
    E.4Principal exclusion criteria
    1. Presence of skin comorbidities that may interfere with the study assessments.
    2. Evidence of acute contact dermatitis at screening.
    3. Evidence of other Lichen planus variants including but not limited to hypertrophic, atrophic, follicular (including lichen planopilaris), and bullous cutaneous forms. Evidence of asymptomatic reticulate or hypertrophic oral Lichen planus.
    4. History of allergy to any component of the study medication.
    5. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose.
    6. Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient’s participation in this study.
    1. Vorliegen von Haut Komorbiditäten, die eventuell die Studienbewertung beeinträchtigen könnten.
    2. Nachweis einer akuten Kontakt-Dermatitis beim Screening
    3. Nachweis anderer Lichen planus Varianten einschließlich aber nicht begrenzt auf hypertrophe, atrophe, follikuläre (einschließlich Lichen planopilaris), und bullöse kutane Formen. Nachweis von asymptomatischen netzartigen oder hypertrophen oralen Lichen planus.
    4. Allergie gegen jegliche Komponenten der Prüfmedikation.
    5. Frauen im gebärfähigen Alter, die nicht in die Einnahme von hochwirksamen Verhütungsmethoden vor der ersten Dosisgabe/Beginn der Behandlung, während der Studie und mindestens 12 Wochen nach der letzten Dosis einwilligen.
    6. Schwangere oder stillende Frauen oder Frauen, die planen schwanger zu werden oder während der Studienteilnahme zu stillen.
    7. Teilnehmer, die gegenwärtig an einer anderen Studie mit Gerätestudie oder Arzneimittelprüfung teilnehmen und das Arzneimittel innerhalb der letzten 90 Tage vor Screening erhalten haben.
    E.5 End points
    E.5.1Primary end point(s)
    Therapeutic efficacy defined as the percentage of patients achieving a clinical response (IGA 0 or 1) in mucosal disease at week 12.
    Therapeutische Wirksamkeit definiert als der Anteil an Patienten, welche eine klinische Verbesserung, gemessen am IGA (0-1) in mukosaler Erkrankung in Woche 12, erzielt haben.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 Wochen
    E.5.2Secondary end point(s)
    Improvement of the Participant self-assessment (PSA) from baseline.
    Improvement of the Physician Assessment of Surface Area of Disease (PSAD) from baseline.
    Improvement of the pain on Visual Analogue Scale (VAS) from baseline.
    The Improvement of pruritus (itching) on Visual Analogue Scale (VAS) from baseline.
    The Improvement of immunological effects of upadacitinib from baseline.
    Improvement of DLQI from baseline.
    Verbesserung der Teilnehmer-Selbsteinschätzung (PSA) zur Baseline.
    Verbesserung der ärztlichen Beurteilung der Krankheitsoberfläche (PSAD) zur Baseline.
    Verbesserung des Schmerzes auf einer visuellen Analogskala (VAS) zur Baseline
    Verbesserung des Juckreizes auf einer visuellen Analogskala (VAS) zur Baseline.
    Verbesserung der immunologischen Effekte zur Baseline
    Verbesserung des DLQI zur Baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSA: week 2, 4, 6, 8, and 12
    PSAD: week 4, 8, and 12
    Pain VAS: week 4, 8, and 12
    Itch VAS: week 4, 8, and 12
    Immunological effects: week 12
    DLQI: week 4, 8, and 12
    PSA: Woche 2, 4, 6, 8, and 12
    PSAD: Woche 4, 8, and 12
    Pain VAS: Woche 4, 8, and 12
    Itch VAS: Woche 4, 8, and 12
    Immunological effects: Woche 12
    DLQI: Woche 4, 8, and 12
    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 No
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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: 22
    F.1.3Elderly (>=65 years) No
    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 state22
    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
    Keine
    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 Decision2022-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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