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    Summary
    EudraCT Number:2020-005518-16
    Sponsor's Protocol Code Number:U3P
    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:2021-03-24
    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 number2020-005518-16
    A.3Full title of the trial
    U3P study - Upadacitinib in Psoriatic Arthritis Pain Processing
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    U3P study - Upadacitinib in Psoriatic Arthritis Pain Processing
    A.3.2Name or abbreviated title of the trial where available
    U3P
    A.4.1Sponsor's protocol code numberU3P
    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 supportAbbvie
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Erlangen
    B.5.2Functional name of contact pointMedizinische Klinik 3
    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 number004991318539133
    B.5.5Fax number004991318534770
    B.5.6E-mailgeorg.schett@uk-erlangen.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 RINVOQ 15mg Retardtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 nameUPADACITINIB
    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 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
    Psoriatic arthritis
    Psoriasisarthritis
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10037162
    E.1.2Term Psoriatic arthropathy
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 describe early and long term central nervous system (CNS) pain response due to blood oxygenation level dependent (BOLD) signal changes in fMRI of the brain to upadacitinib treatment in psoriatic arthritis
    E.2.2Secondary objectives of the trial
    To identify biomarkers associated with early and long term (CNS) pain response due Blood oxygenation level dependent (BOLD) signal changes in fMRI of the brain to upadacitinib treatment in psoriatic arthritis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must understand and voluntarily sign an informed consent form including written consent for data protection
    Adults aged ≥ 18 years and < 65 years at time of consent
    Patients fulfilling CASPAR criteria for PsA
    Subjects must have active hand joint involvement (at least one swollen/tender joint)
    Indication for systemic treatment
    Subjects who failed to respond to or are intolerant to at least one csDMARD
    Subjects who were not exposed to more than one bDMARD before; for bDMARDs the wash-out period should be at least three times the half-life of the bDMARD concerned.
    Eligibility for the treatment with Upadacitinib according to the EU label
    Glucocorticoids less than 10mg/day will be allowed
    Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with Females of Childbearing Potential (FCBP) while on study medication and for at least 28 days after taking the last dose of study medication.
    Females of childbearing potential (FCBP) must have a negative urine pregnancy test at baseline and must be willing to use one highly-effective form of birth control when engaging in reproductive sexual activity while on study medication and for at least 28 days after taking the last dose of study medication.
    Must be able to adhere to the study visit schedule and other protocol requirements
    E.4Principal exclusion criteria
    - Prior exposure to any Janus kinase (JAK) inhibitor
    - ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl
    - Any contraindication to perform MRI
    - Anti-CCP- Antibody positivity
    - Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, Behcet`s disease, vasculitis or autoimmune hepatitis.
    - Malignancy risk factors (e.g. current malignancy or history of malignancy)
    - Any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment.
    - Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
    - Immunocompromised patients
    - Uncontrolled severe concomitant disease
    - Pregnant or lactating females
    - Known hypersensitivity to upadacitinib or any other drug components
    - Requirement for immunization with live vaccine during the trial period or within 4 weeks preceding baseline
    - History of venous thrombosis or pulmonary embolism, inherited coagulation disorder, planned major surgery, immobilisation
    - History of atherosclerotic cardiovascular disease or other cardiovascular risk factors
    - Current or past long-time smokers
    - Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
    - Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
    - Evidence of severe hepatic insufficiency defined as Child-Pugh score ≥ 10 (C)
    - Abnormal liver function tests such as GOT (AST), GPT (ALT), alkaline phosphatase or bilirubin. The investigator should be guided by the following criteria:
    o GOT, GPT, alkaline phosphatase: any single parameter may not exceed 3x upper limit of normal (ULN). A single parameter elevated up to and including 3x ULN should be re-checked once more as soon as possible.
    o Total bilirubin: if total bilirubin concentration is increased above 2x ULN, total bilirubin should be differentiated into direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1,6mg/dl (exemption: the diagnose of gilbert´s syndrome has already been established or based on higher levels of unconjugated bilirubin without either signs of other liver problems or red blood cell breakdown can be made)
    - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
    - Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG).
    - Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
    - Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g. family members)
    - Have participated in this study before with respect to having received upadacitinib. Re-Screening is allowed once
    E.5 End points
    E.5.1Primary end point(s)
    BOLD signal voxel count at week 1 and week 12 compared to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline (BL), week one and week 12
    E.5.2Secondary end point(s)
    fMRI: (week 1 and week 12 compared to baseline)
    - activation size of the BOLD signal (number) at week 1 and week 12 compared to baseline
    - amplitude of the BOLD signal (number) at week 1 and week 12 compared to baseline
    - graph-theoretical parameters for all structures along the pain pathway at baseline and week 1 and week 12
    - changes in brain anatomy defined as rewiring of brain centers at week 12 compared to baseline.

    Clinical evaluation, PROs and Composite outcome measures:
    - Patient global assessment of pain, Patient global assessment of disease activity, Physician global assessment of disease activity (VAS)
    - Joint count: 66/68
    - DAS28 (CRP)
    - DAPSA
    - SPARCC
    - LEI
    - MASES
    - Dactylitis Score
    - PASI
    - PSAID
    - PASDAS
    - SF 36
    - MDA
    - HAQ-DI
    - FACIT-Fatigue
    PATIENT DIARY
    Ultrasound Synovitis Score of the MCP joints
    TISSUE EXPLORATIVE SERUM BIOMARKERS
    E.5.2.1Timepoint(s) of evaluation of this end point
    BL, week 1, week 4, week 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 Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    LSLV
    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 months9
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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)
    Standard of care
    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 Decision2021-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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