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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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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    EudraCT Number:2008-000197-20
    Sponsor's Protocol Code Number:R013
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-000197-20
    A.3Full title of the trial
    Multi-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of Bimosiamose 5% Cream for the treatment of patients with chronic plaque type psoriasis
    A.3.2Name or abbreviated title of the trial where available
    Psoriasis POC
    A.4.1Sponsor's protocol code numberR013
    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 SponsorRevotar Biopharmaceuticals AG
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    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 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 nameBimosiamose 5% Cream
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBimosiamose
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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. medicinal product typepan-selectin antagonist
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic plaque-type psoriasis (psoriasis vulgaris)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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 the trial is the evaluation of the safety and efficacy of topical Bimosiamose 5% Cream for the treatment of male and postmenopausal or sterile female patients with mild to moderate chronic plaque type psoriasis.
    Clinical efficacy will be assessed by the improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50, PASI excluding the scalp) at Day 112 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream.
    E.2.2Secondary objectives of the trial
    • To assess the global effect of Bimosiamose treatment on psoriasis over the study period
    • To assess the induration, erythema, scaling and pruritus in two Index Lesions over the study period
    • To assess the time to effective treatment
    • To determine patient satisfaction with Bimosiamose treatment
    • To assess the potential for rebound effects of treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is one sub-study with two parts and with the same study title. The sub-study is part of the study protocol, version 12 from September 12, 2008. The objectives are:

    Sub-Study Part A, conducted in one center in Berlin (Charité):
    •To assess the histological and immunohistological changes and changes in the expression profile of psoriasis relevant mediators in skin biopsies
    •To assess the changes of psoriasis relevant mediators in blood

    Sub-Study Part B, conducted in the center of Magdeburg:
    •To assess topoproteome changes in skin biopsies
    E.3Principal inclusion criteria
    All of the following criteria have to be met for inclusion of a patient with chronic plaque type psoriasis into the study:
    1. Male patients or postmenopausal female patients with amenorrhea of at least twelve consecutive months duration prior to screening (medical certificate by gynecologist) or sterile female patients with documented hysterectomy or tubal ligation
    2. PASI score of 5-15 (plaques must not be exclusively over the knees and elbows) and a PGA of ≤ moderate
    3. At least 18 years of age
    4. Time and ability to complete the study and comply with instructions
    5. Written informed consent
    E.4Principal exclusion criteria
    Patients are to be excluded from the study when one or more of the following conditions are met:
    1. Active skin infection or other skin conditions that may influence the evaluation of the psoriatic lesions e.g. eczema
    2. More than 20% Body Surface Area (BSA) affected by psoriasis (excluding palmar or plantar located)
    3. Use of anti-psoriasis medication or treatments below (except emollients):
    a. Retinoid, calcipotriene, coal tar or anthralin ≤14 days prior to Baseline
    b. Systemic and topical corticosteroids, fumarate, methotrexate, cyclosporine or systemic retinoids, ≤30 days prior to Baseline
    c. Prolonged sun exposure ≤30 days prior to Baseline
    d. Laser therapy or Photodynamic therapy (or PUVA) ≤30 days prior to Baseline
    e. Etanercept, efalizumab, infliximab or adalimumab ≤90 days prior to Baseline
    f. Alefacept or IL-12/23 inhibitors ≤180 days prior to Baseline
    g. On lithium, antimalarials, beta blockers or ACE inhibitors unless the dose has been stable for 60 days prior to entry and is planned to remain stable during the study
    4. Clinical study participation with any investigational drug less than 90 days prior to study entry or planning to receive an investigational drug during the study period
    5. Previous treatment with Bimosiamose
    6. Known allergy to any of the components of Bimosiamose 5% Cream
    7. Cancerous or pre-cancerous lesions
    8. Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to stay in the study for 140 days because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable; or patients who have a concomitant condition that might confuse or confound study assessments)
    9. Severe allergies manifested by a history of anaphylaxis or a history of multiple allergies
    10. Receiving immunosuppressive therapy
    11. Positive results on urine drug screen
    12. Current signs of alcohol abuse
    13. The patient has laboratory test results that indicates acute or chronic infectious hepatitis A, B or C or an infection with human immunodeficiency virus (HIV)
    14. gamma-GT ≥3 times the upper limit of normal
    15. Platelet count ≥10% below the lower limit of normal
    16. Subject is institutionalized because of legal or regulatory order
    E.5 End points
    E.5.1Primary end point(s)
    Improvement from Baseline of modified Psoriasis Area and Severity Index by 50% (mPASI 50) at week 16 (End of Treatment) in patients treated with Bimosiamose 5% Cream compared with Placebo Cream. mPASI is the full PASI score minus the scalp component.
    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 Yes
    E.6.13.1Other scope of the trial description
    substudy part A: Analysis of Psoriasis relevant mediators; substudy part B: Topoproteome analysis
    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. 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.8.3 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 concerned12
    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 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
    The treatment period will take 16 weeks, the follow-up period further 4 weeks.
    The end of the trial is the last visit of the last patient undergoing the trial (last patient out).
    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 months8
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state105
    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)
    Since only patients will be included that do not necessarily need treatment, further treatment is not intended after the patient has ended the participation in the trial.
    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 Decision2008-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-20
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