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    Summary
    EudraCT Number:2007-003922-70
    Sponsor's Protocol Code Number:TUD-PPPDD1-021
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-08-08
    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 number2007-003922-70
    A.3Full title of the trial
    Uncontrolled, open Phase IIa study to investigate efficacy and safety of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis (PPP)
    A.3.2Name or abbreviated title of the trial where available
    PPP Study
    A.4.1Sponsor's protocol code numberTUD-PPPDD1-021
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTechnische Universität Dresden
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Raptiva
    D.2.1.1.2Name of the Marketing Authorisation holderSerono Europe Ltd., 56 Marsh Wall, London E14 9TP, UK
    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.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEfalizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typerecombinant humanized monoclonal 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
    moderate to severe palmoplantar pustular psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037159
    E.1.2Term Psoriasis pustular
    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 efficacy of efalizumab in patients with moderate to severe palmoplantar pustular psoriasis
    E.2.2Secondary objectives of the trial
    To collect safety data for efalizumab in patients with moderate to severe palmoplantar pustular psoriasis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patient with (at least 6 months or longer) moderate to severe palmoplantar pustular psoriasis with or without psoriasis at other sites
    2. PGA rating of moderate (4), severe (5) or very severe (6) for palmoplantar pustular psoriasis with at least ten fresh pustules at screening visit and baseline
    3. Age 18 to 75 years
    4. Body weight £125 kg
    5. Naïve to efalizumab treatment
    6. Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (Study Day 0 = SD 0) is required, if not indicated otherwise. Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0)
    7. Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0)
    8. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of six months is required for these agents prior to receiving the first dose of study drug (SD 0)
    9. Treatment regimens of b blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0)
    10. No required vaccination (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).
    11. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
    12. Willingness to participate in photo documentation
    13. For women of childbearing potential: Use of an acceptable method of contraception (implants, oral contraceptives, intrauterine device, sterilization or sterilized partner) to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and up to 3 months after the last dose of efalizumab
    14. Agreement to participate in the study
    15. Signed informed consent
    E.4Principal exclusion criteria
    1. Guttate, erythrodermic or chronic plaque psoriasis as sole or predominant form of psoriasis
    2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
    3. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection. This includes diagnoses that required more than 2 weeks of therapy, such as endocarditis and osteomyelitis that have been treated in the past 6 months. In addition, if the patient is currently receiving antibiotics, antivirals or antifungals for an infection or for suppression or prophylaxis for any diagnosis, the patient will be excluded
    4. History of opportunistic infections (e.g., systemic fungal infections, parasites)
    5. History of or ongoing active tuberculosis (TB) or other serious infections
    6. History of clinically significant thrombocytopenia, bleeding disorders or hemolytic anemia
    7. Previous exposure to efalizumab
    8. Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)
    9. Application of systemic treatments within 3 months prior to receiving the first dose of study drug (SD 0)
    10. Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within one month prior to receiving the first dose of study drug (SD0)
    11. UV/PUVA treatment within 1 month prior to receiving first dose of study drug (SD 0)
    12. Application of any investigational drug or treatment less than six months ago prior to receiving the first dose of study drug (SD 0)
    13. Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)
    14. Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
    15. Diagnosis of hepatic cirrhosis, regardless of cause or severity
    16. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
    17. History of drug abuse within the last 5 years
    18. History of seropositivity for human immunodeficiency virus (HIV)
    19. History of seropositivity for hepatitis B or C virus
    20. WBC count <4,000µ/L or >14,000/µL
    21. Hematocrit (HCT) <30% or hemoglobin (Hgb) level <11 g/dL
    22. Platelet count <150,000 cells/µL
    23. Hepatic enzymes >3 times the upper limit of normal
    24. Serum creatinine >2 times the upper limit of normal
    25. Pregnancy or lactation
    26. Any medical condition that, in the judgment of the investigator, would jeopardize the patient’s safety following exposure to study drug
    27. Patient unwilling or unable to follow the protocol requirements
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Number of fresh pustules (relative change at week 12 compared to baseline) Secondary efficacy outcome measures include:
    - The proportion of patients who achieve a PGA rating of absence of disease (1), very mild disease (2), or mild disease (3) at Day 84
    - The proportion of patients who achieve a PGA rating of absence of disease (1), very mild disease (2), or mild disease (3) at Day 42
    - The change from Day 0 to Day 84 in the following measures: DLQI, PAGA, PP-PASI, PASI
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 Information not present in EudraCT
    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
    End of trial is the last visit (follow up) of the last subject
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    Further treatment of patients at the end of study participation will follow standard therapies for PPP patients, exhausting all therapy options that are currently available
    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 Decision2007-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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