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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-000706-10
    Sponsor's Protocol Code Number:22-00274
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-20
    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 number2022-000706-10
    A.3Full title of the trial
    Pilot study on Administration of Tildrakizumab in patients with Hidradenitis Suppurativa.
    Pilotstudie zur Anwendung von Tildrakizumab bei Patienten mit Akne inversa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on administration of Tildrakizumab in patients with Hidradenitis.
    Studie zur Anwendung von Tildrakizumab bei Patienten mit Akne.
    A.3.2Name or abbreviated title of the trial where available
    PATHS
    PATHS
    A.4.1Sponsor's protocol code number22-00274
    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 SponsorUniversity Medical Center of the Johannes Gutenberg- University Mainz
    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 supportAlmirall Hermal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg- University Mainz
    B.5.2Functional name of contact pointProf. Dr. med. Petra Staubach-Renz
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+496131175244
    B.5.5Fax number+496131175594
    B.5.6E-mailcrc-hautklinik@unimedizin-mainz.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 Ilumetri 100 mg Injektionslösung in einer Fertigspritze
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNTildrakizumab
    D.3.9.1CAS number 1326244-10-3
    D.3.9.4EV Substance CodeSUB130334
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 typehumanised monoclonal IgG1/κ-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
    Hidradenitis suppurativa
    Akne inversa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis
    Akne
    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 10076650
    E.1.2Term Acne inversa
    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
    The primary objective of this study is to evaluate the initial efficacy of Tildrakizumab in adult participants with moderate to severe HS at Week 20.
    Das primäre Ziel dieser Studie ist die Bewertung der Wirksamkeit von Tildrakizumab bei erwachsenen Patienten mit mittelschwerer bis schwerer Akne inversa (HS) in Woche 20.
    E.2.2Secondary objectives of the trial
    • to evaluate the efficacy of Tildrakizumab on other measures of disease activity in study participants with moderate to severe HS
    • to evaluate the efficacy of Tildrakizumab on HiSCR, other HS Scoresscores, and other clinical measures of disease activity at various timepoints in study participants with moderate to severe HS
    • to evaluate the efficacy of Tildrakizumab on abscesses, nodules, and draining tunnels at various timepoints in study participants with moderate to severe HS
    • to evaluate the efficacy of Tildrakizumab on patient-reported outcome measures at various timepoints in study participants with moderate to severe HS
    • to evaluate the changes in pathology of Tildrakizumab in study participants with moderate to severe HS
    • to evaluate the sleep pattern of the patients before, during and after therapy initiation.
    • to evaluate change of physical activity during the study
    Die sekundären Ziele dieser Studie sind die Bewertung der Wirksamkeit von Tildrakizumab mithilfe von HiSCR, anderen HS-Scores und anderen klinische Messgrößen der Krankheitsaktivität zu verschiedenen Zeitpunkten, Einfluss der Tildrakizumab-Behandlung auf den Rückgang der entzündlichen Knötchen, Abszesse und Drainagetunnel, auf die Veränderung der Krankheitswahrnehmung durch die Patienten, auf die Veränderung deren Schlafverhaltens und körperlicher Aktivität sowie die pathologische Veränderung der Haut im Verlauf der Behandlung.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Moderate to severe HS for at least 1 year (365 days) prior to the baseline visit
    3. Stable HS for at least 1 month (28 days) prior to the first study visit
    4. HS lesions present in at least one distinct anatomic area
    5. History of an inadequate response to an antibiotics treatment of HS
    6. Total abscess and inflammatory nodule (AN) count of ≥3 at the screening and first study visit
    7. Written informed consent.
    1. Alter ≥ 18 Jahre
    2. Mäßige bis schwere HS seit mindestens 1 Jahr (365 Tage) vor der Baseline-Visite
    3. Stabile HS seit mindestens 1 Monat (28 Tage) vor der Baseline-Visite
    4. HS-Läsionen in mindestens einem bestimmten anatomischen Bereich
    5. Unzureichendes Ansprechen auf eine antibiotische Behandlung von HS in der Vergangenheit
    6. Gesamtzahl der Abszesse und entzündlichen Knötchen (AN) von ≥3 beim Screening und bei der Baseline-Visite
    7. Schriftliche Einwilligung nach Aufklärung
    E.4Principal exclusion criteria
    1. Any other active skin disease or condition that could interfere with assessment of HS
    2. Investigational findings or clinical history that rule out treatment with tTildrakizumab (such as tuberculosis, HIV, hepatisis, mycobacterial infection)
    3. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    4. Is under therapy with any medication that effects the sleep (e.g. antidepressants)
    5. Receipt of therapies that may interfere with with tTildarakizumab treatment or with assessment of HS
    6. Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in the study or within 12 weeks following the last administration of tTildarakizumab
    7. Suicidal ideation or suicidal behavior in the last 6 months, substance abuse (drug or alcohol) disorder within the last 12 months.
    1. Jede andere aktive Hautkrankheit oder jeder andere Zustand, der die Bewertung von HS beeinträchtigen könnte
    2. Untersuchungsergebnisse oder klinische Vorgeschichte, die eine Behandlung mit Tildrakizumab ausschließen (z. B. Tuberkulose, HIV, Hepatitis, mykobakterielle Infektion)
    3. ein Zustand, bei dem nach Ansicht des Prüfers die Studienteilnahme nicht im besten Interesse des Patienten wäre (z. B. Beeinträchtigung des Wohlbefindens) oder der die im Prüfplan vorgesehenen Bewertungen verhindern, einschränken oder vereiteln könnte
    4. Behandlung mit Medikamenten, die den Schlaf beeinflussen (z. B. Antidepressiva)
    5. Therapien, die die Behandlung mit Tildrakizumab oder die Bewertung von HS beeinträchtigen könnten
    6. Schwangerschaft oder Stillen, eine geplante Schwangerschaft (bzw. Schwangerschaft der Partnerin bei den männlichen Teilnehmern) während der Studie oder innerhalb von 12 Wochen nach der letzten Verabreichung von Tildrakizumab
    7. Suizidgedanken oder suizidales Verhalten in den letzten 6 Monaten, Substanzmissbrauch (Drogen oder Alkohol) in den letzten 12 Monaten
    E.5 End points
    E.5.1Primary end point(s)
    HiSCR50 at Week 20
    HiSCR50 in Woche 20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 20
    Woche 20
    E.5.2Secondary end point(s)
    - Absolute change from Baseline in DLQI Total Score at Week 20
    - Absolute change from Baseline in International Hidradenitis Suppurativa Severity Score System at Week 20
    - Absolute and percentage change from Baseline in CRP at Week 20
    - HiSCR25, HiSCR75, HiSCR90, and HiSCR100 at Week 20
    - Absolute and percentage change (worst and average pain) from Baseline in HS Skin Pain score (11-point numeric rating scale) at Week 20
    - Absolute change from Baseline in DLQI Total Score at Week 20
    - Absolute change from Baseline IPQA Total Score at Week 20
    - Absolute change from Baseline PSQI Total Score at Week 20
    - Absolute change from Baseline ISI Total Score at Week 20
    - Absolute change from Baseline MOS-SS Total Score at Week 20
    - Absolute change from Baseline ESS Total Score at Week 20
    - Absolute change from Baseline in vital signs at Week 20
    - Absolute change from Baseline in Hidradenitis Suppurativa Physician’s Global Assessment at Week 20
    - Absolute change from Baseline in PGI-S-HS at Week 20
    - Absolute change from Baseline in PGI-C-HS at Week 20
    - Absolute change from Baseline in BMI at Week 20
    - Absolute change from Baseline in clinical laboratory values (chemistry and hematology) at Week 20
    - Changes in inflammatory activity and severity of acne inversa in histopathological analyses at Week 20
    - Sleep disturbances
    - Safety and tolerability of Tildrakizumab: Analysis of adverse events and laboratory data
    - Absolute Veränderung des DLQI-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung im International HS Severity Score System zwischen Baseline und Woche 20
    - Absolute und prozentuale Veränderung des CRP-Wertes zwischen Baseline und Woche 20
    - HiSCR25, HiSCR75, HiSCR90 und HiSCR100 in Woche 20
    - Absolute und prozentuale Veränderung (schlimmster und durchschnittlicher Schmerz) gegenüber dem Ausgangswert im HS-Hautschmerz-Score (11-stufige numerische Bewertungsskala) zwischen Baseline und Woche 20
    - Absolute Veränderung des DLQI-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung des IPQA-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung des PSQI-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung des ISI-Gesamtwerts zwischen Baseline und Woche 20
    - Absolute Veränderung des MOS-SS-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung des ESS-Gesamtscores zwischen Baseline und Woche 20
    - Absolute Veränderung der Vitalparameter zwischen Baseline und Woche 20
    - Absolute Veränderung der HS Gesamtbewertung durch den Arzt zwischen Baseline und Woche 20
    - Absolute Veränderung des PGI-S-HS zwischen Baseline und Woche 20
    - Absolute Veränderung des PGI-C-HS zwischen Baseline und Woche 20
    - Absolute Veränderung des BMI zwischen Baseline und Woche 20
    - Absolute Veränderung der klinischen Laborwerte (Chemie und Hämatologie) zwischen Baseline und Woche 20
    - Veränderungen der Entzündungsaktivität und des Schweregrads der HS in den histopathologischen Analysen in Woche 20
    - Schlafstörungen
    - Sicherheit und Verträglichkeit von Tildrakizumab: Analyse von unerwünschten Ereignissen und Laborwerten
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 20
    Woche 20
    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 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 No
    E.8.1.1Randomised No
    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
    1-cohort, prospective
    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.8.3 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
    Letzte Visite, letzter Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state15
    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)
    After the end of the study, the subjects will be treated according to best clinical practice.
    Nach Abschluss der klinischen Prüfung werden die Patienten gemäß den anerkannten nationalen und internationalen Empfehlungen und Leitlinien behandelt.
    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 Decision2022-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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