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    Summary
    EudraCT Number:2018-000335-27
    Sponsor's Protocol Code Number:EPos
    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:2018-07-09
    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 number2018-000335-27
    A.3Full title of the trial
    Early PsA on treatment strategy
    Strategie zur Frühbehandlung einer Psoriasis Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Early PsA on treatment strategy
    Strategie zur Frühbehandlung einer Psoriasis Arthritis
    A.4.1Sponsor's protocol code numberEPos
    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 SponsorUniversitätsklinikum Erlangen
    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 supportCelgene International
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen, Medizinische Klinik 3
    B.5.2Functional name of contact pointLead Clinical Physician
    B.5.3 Address:
    B.5.3.1Street AddressUlmenweg 18
    B.5.3.2Town/ cityErlangen
    B.5.3.3Post code91054
    B.5.3.4CountryGermany
    B.5.4Telephone number0049913185 32093
    B.5.5Fax number0049913185 35784
    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 Otetzla®
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated 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 INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number30
    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.IMP: 2
    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 Otetzla®
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe B.V.
    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 nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Film-coated 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 INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriasis vulgaris
    Psoriasis vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    Schuppenflechte
    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 10050576
    E.1.2Term Psoriasis vulgaris
    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 investigate the effects of apremilast treatment on bone changes in Pso patients with bony changes and subclinical inflammation.
    Untersuchung des Effekts einer Apremilast-Behandlung auf Knochenveränderungen bei Patienten mit Psoriasis mit nachgewiesenen Knochenveränderungen und subklinischen Entzündungszeichen.
    E.2.2Secondary objectives of the trial
    To investigate the effects of apremilast on signs of inflammation in patients with Pso
    Untersuchung des Effekts von Apremilast auf Entzündungszeichen bei Patienten mit Psoriasis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Must be male or female and aged ≥ 18 years at time of consent
    - Subjects must have moderate to severe psoriasis vulgaris for at least 6 weeks prior to inclusion and must have active disease of the skin
    - Indication for systemic treatment of the skin
    - Patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)
    - Biological and tsDMARD naive
    - Presence of bony changes in HR-pQCT and subclinical inflammation (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand must be detectable
    - Männliche oder weibliche Patienten ≥ 18 Jahre zum Zeitpunkt des Einschlusses
    - Vorliegen einer mittelschweren bis schweren Psoriasis Vulgaris für mindestens 6 Wochen vor Einschluss und aktiver Hauterkrankung
    - Indikation zur systemischen Behandlung der Haut
    - Patienten, die auf eine andere systemische Therapie einschließlich Ciclosporin, Methotrexat oder Psoralen in Kombination mit UV-A Licht (PUVA) nicht angesprochen haben, bei denen eine solche Therapie kontraindiziert ist, oder die diese nicht vertragen.
    - Patienten die bisher keine biologischen oder ts-DMARD erhalten haben
    - Vorliegen von nachgewiesenen Knochenveränderungen im HR-pQCT und von subklinischen Entzündungszeichen (Synovialitis, Tenosynovitis) oder Osteitis im MRT der dominanten Hand
    E.4Principal exclusion criteria
    - Any contraindications for the treatment with apremilast
    - Previous exposure to apremilast or tsDMARD or biological DMARD treatment
    - Current treatment with synthetic or biologic DMARDs
    - Investigational study drug within 4 weeks (or 5 halflives, whichever is longer) prior to randomisation
    - Any contraindication to perform MRI or failure to perform baseline MRI or HR-pQCT
    - Patients fulfilling CASPAR criteria for PsA
    - Anti CCP2 positivity
    - Evidence of underweight, defined as BMI < 18,5 kg/m2
    - Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
    - History of malignancy within previous 5 years
    - Patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption
    - Chronic infection such as hepatitis B or C infection
    - Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
    - Immunocompromised or HIV-positive patients
    - Uncontrolled severe concomitant disease (including diabetes with plasma glucose >11.1 mmol/l rsp. 200 mg/dl, heart insufficiency >= NYHA III, COPD with severity >= GOLD 3, asthma according to GINA classification >= step 3
    - Evidence of severe renal dysfunction defined as eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
    - Prior history of suicide attempt at any time in the subject's life time prior to screening and baseline, or major psychiatric illness requiring hospitalization within the last 3 years
    - Pregnant or lactating females
    - Concomitant medication that can cause psychiatric symptoms (e.g. rifampicine, phenobarbital, carbamazepine, phenytoin, St John's wort)
    - Jegliche Gegenanzeige gegen eine Behandlung mit Apremilast
    - Vorhergehende Behandlung mit Apremilast, tsDMARDs oder biologischen DMARDS
    - Gleichzeitige Behandlung mit synthetischen oder biologischen DMARDs.
    - Behandlung mit einem Studienmedikament in den letzten 4 Wochen (oder 5 Halbwertszeiten, je nachdem was länger ist) vor Randomisierung.
    - Jegliche Gegenanzeige für die Durchführung eines MRTs oder Fehlen einer MRT-Untersuchung oder der HR-pQCT Untersuchung bei Baseline.
    - Patienten, die die CASPAR Kriterien eine PsA erfüllen
    - Anti CCP2 positiver Befund
    - Untergewicht, definiert als BMI < 18.5 kg/m2
    - Jede andere autoimmun- od. entzündliche Erkrankung wie SLE, PSS, MCTD, SpA, Behcet Syndrom, Vaskulitis oder Autoimmun-Hepatitis
    - Maligne Erkrankung innerhalb der vergangenen 5 Jahre
    - Patienten mit seltenen erblichen Unverträglichkeiten wie Galaktoseintoleranz, Lapp-Laktase-Mangel oder Glukose-Galaktose-Malabsorption
    - Chronische Infektion wie Hepatitis B oder C Infektion
    - Bekannte schwere Infektion (z.B. Hepatitis, Pneumonie od. Pyelonephritis) in den vergangenen 3 Monaten
    - Patienten mit geschwächter Immunabwehr oder HIV positive Patienten
    - Unkontrollierte schwere Begleiterkrankung (einschließlich Diabetes mit Plasma-Glukose > 11.1 mmol/l bzw. 200 mg/dl, Herzinsuffizienz >= NYHAIII, COPD mit Schweregrad >= GOLD 3, Asthma nach GINA Klassifikation>=3)
    - Schwere Nierenfunktionseinschränkung definiert als eGFR < 30 ml/min/1.73m2 (nach der MDRD Formel) beim Screening (Visite 1)
    - Selbstmordversuch irgendwann im Leben des Patienten vor Screening und Baseline oder schwere psychiatrische Erkrankung die einer Hospitalisierung bedarf während der vergangenen 3 Jahre
    - Schwangere oder stillende Frauen
    - Begleitmedikation die zu psychiatrischen Symptomen führen kann (Rifampicin, Phenobarbital, Carbamazepin, Phenytoin, Johanniskraut)
    E.5 End points
    E.5.1Primary end point(s)
    Change in osteophyte volume measured by HR-pQCT of the dominant hand between baseline and 24 weeks follow-up.
    Änderung im Osteophyten-Volumen zwischen Baseline und nach 24 Wochen Behandlung, gemessen mittels HR-pQCT der dominanten Hand
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 24 weeks after start of treatment
    Baseline und 24 Wochen nach Behandlungsbeginn
    E.5.2Secondary end point(s)
    - MRT: PSRAMRIS scores (synovitis, tenosynovitis, bone eraosions, bone marrow oedema, composite of inflammatory components)
    - Osteophytes, erosions in µ-CT
    - DAS28, MDA, DAPSA, HAQ-DI, SPARCC, LEI, MASES, PSAID, PASI, SF-36, PASDAS
    - optional: serum biomarkers, skin biopsy and gut microbiota composition
    -MRT: PSRAMRIS scores (Synovitis, Tenosynovitis, Knochenerosion, Knochenmarksödem, Summe entzündlicher Komponenten)
    - Osteophyten, Erosionen im µ-CT
    - DAS28, MDA, DAPSA, HAQ-DI, SPARCC, LEI, MASES, PSAID, PASI, SF-36, PASDAS
    - optional: Biomarker im Serum und in Hautpbiopsien, sowie Darm-Mikrobiom-Zusammensetzung
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and month 3 and 6 after start of treatment
    Vor Behandlungsbeginn und 3 und 6 Monate nach Start der Behandlung
    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 No
    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 trial1
    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 (last visit defined as the follow up visit 1 month after end of treatment)
    LVLS (der letzte Besuch ist hier als der Besuch 1 Monat nach Behandlungsende defininiert)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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; Further treatment according to the decison of the treating physician
    Keine; Weiterbehandlung nach Maßgabe des behandelnden Arztes
    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 Decision2018-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-17
    P. End of Trial
    P.End of Trial StatusOngoing
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