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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2008-007458-37
    Sponsor's Protocol Code Number:973
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-22
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-007458-37
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, multicentre, multiple dose, cohort study with escalating doses to evaluate the safety and efficacy of the humanized monoclonal antibody (mab) BT061 administered subcutaneously or intravenously as 8 repeated doses to patients with moderate to severe chronic plaque psoriasis.
    A.4.1Sponsor's protocol code number973
    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 SponsorBiotest AG
    B.1.3.4CountryGermany
    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.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 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 nameBT061
    D.3.2Product code BT061
    D.3.4Pharmaceutical form Solution for infusion
    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 INNHumanised anti-CD4 IgG1 monoclonal antibody
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHumanised anti-CD4 IgG1 monoclonal antibody
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 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 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 nameBT061
    D.3.2Product code BT061
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHumanised anti-CD4 IgG1 monoclonal antibody
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHumanised anti-CD4 IgG1 monoclonal antibody
    D.3.9.2Current sponsor codeBT061
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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 No
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with moderate to severe chronic plaque psoriasis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10037153
    E.1.2Term Psoriasis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this clinical phase IIa study is to demonstrate efficacy and safety of multiple doses of BT061.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to identify the most effective subcutaneous dose strength in comparison to placebo and to compare the efficacy of subcutaneous versus intravenous administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To participate in this trial, patients must meet all the following criteria:

    1. Male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to Screening.
    2. BSA involvement > 10% for more than 6 months.
    3. PASI ≥ 10.
    4. Age ≥ 18 to ≤ 75 years.
    5. Body mass index (BMI) of 18–30 kg/m2 with a body weight between 50 and 130 kg.
    6. Patient on any medication prescribed for another indication must be at stable dose for at least 14 days prior to the administration of BT061 or placebo.
    7. Cluster of differentiation 4 (CD4) cell count at Screening Visit is ≥ 75% the lower limit of normal.
    8. B cell count at Screening Visit is ≥ 75% the lower limit of normal.
    9. Written informed consent (signed and dated by patient).
    E.4Principal exclusion criteria
    1. Erythrodermic, guttate or palmar pustular psoriasis
    a. Mixed forms of plaque psoriasis (psoriasis vulgaris) with palmar pustular psoriasis, such as psoriasis vulgaris cum pustulatione, are allowed as long as psoriasis vulgaris is the predominant form.
    b. Patients with a history of psoriasis guttata are admitted as long as psoriasis vulgaris is the predominant diagnosis at the time of inclusion
    c. Patients with ongoing psoriasis guttata cannot be enrolled.
    2. Treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of BT061/placebo. Compounds where 5 half-lives exceed 30 days have therefore to be washed out for at least 5 half-lives.
    3. Treatment with systemic retinoids, corticosteroids and immunosuppressants within 4 weeks prior to the administration of BT061 or placebo.
    4. Any other systemic psoriasis relevant treatment (hydroxychloroquine, chloroquine, lithium) within 4 weeks prior to the administration of BT061 or placebo.
    5. High potency topical treatments (corticosteroids, keratolytics, coal tar) within 2 weeks prior to the administration of BT061 or placebo.
    6. Psoralen and Ultraviolet A (PUVA) therapy within 4 weeks prior to the administration of BT061 or placebo.
    7. Ultraviolet B (UVB) therapy within 2 weeks prior to the administration of BT061 or placebo.
    8. Recent holiday (within the last 2 weeks) with greater than usual sun exposure or plans to go on such a holiday before Final Follow-up visit.
    9. Treatment with leflunomide within 8 weeks prior to the administration of BT061 or placebo (except specific wash out procedure, i. e. 11 days with colestyramine or activated charcoal plus 30 days wash-out).
    10. Clinically relevant abnormalities regarding haematocrit, haemoglobin or platelets, serum concentration of creatinine or bilirubin, or in complete cell count and differential cell count.
    11. Kidney insufficiency as defined by creatinine clearance: < 60 ml/min (Cockcroft Gault equation).
    12. Alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≥ 3 times the upper limit of normal.
    13. History of clinically significant major disease i.e., severe heart/ lung diseases New York Heart Association (NYHA)  3 (class III: patients with marked limitation of activity; comfortable only at rest).
    14. Acute or clinically relevant abnormalities in electrocardiogram (ECG).
    15. History of malignancy during 5 years prior to Screening visit (except squamous or basal cell carcinoma of the skin).
    16. Serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of BT061 or placebo.
    17. Presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis).
    18. Presence or history of severe uncontrolled allergies or anaphylactic reactions.
    19. Presence of severe uncontrolled hypertension or hypotension.
    20. Presence of acute uncontrolled hypothyroidism or hyperthyroidism.
    21. Positive diagnosis of latent or active tuberculosis.
    22. Positive diagnosis for acute or chronic infections (i.e. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at Screening visit.
    23. Positive cytomegalovirus (CMV) viral load in serum at Screening visit.
    24. Positive Epstein-Barr Virus (EBV) immunoglobulin class M (IgM) titre or EBV viraemia at Screening visit. Patients with a positive polymerase chain reaction (PCR) result in lymphocyte deoxyribonucleic acid (DNA) are eligible if all of the following conditions apply: i) absence of clinical signs and symptoms of a beginning or ongoing EBV infection ii) absence of EBV DNA in plasma as determined by PCR iii) negative in EBV IgM titre iv) viral load in lymphocyte DNA below or equal 200 copies per µg.
    25. Patients vaccinated with live, live attenuated or killed vaccines within 3 months prior to and 3 months after the administration of BT061 or placebo.
    27. Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use 2 independent measures of effective contraceptive methods for at least 3 months after the administration of BT061 or placebo (i.e. oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, female sterilisation or condoms).
    32. Former treatment with BT061.
    34. Patients planning to donate blood between 56 days before inclusion in the study and the study Final Follow up Visit.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the response rate defined as the proportion of patients experiencing a 75% reduction in psoriasis using the PASI 75 at the end-of-treatment visit (Visit 18, Week 9). Multiple doses of BT061 or placebo will be administered weekly by intravenous infusion (Cohorts 1 and 2; 0.5 and 2.0 mg BT061, respectively) or subcutaneous administration (Cohorts 3, 4, 5, and 6; 25–100 mg BT061).

    Patients will be screened 4 weeks prior to commencement of the treatment period and will have a pre-treatment visit at Day -5 to -1. The treatment is scheduled for 8 weekly administrations over a period of 8 weeks, followed by an end of treatment visit 1 week after the last treatment (Week 9) and a subsequent follow-up period of 11 weeks (total follow-up: 12 weeks).

    In total, 48 patients are planned to be enrolled into 6 cohorts with 8 patients per cohort: 6 patients receiving the active IMP, BT061, and 2 patients receiving placebo (buffer of BT061), resulting in a randomisation ratio of 3:1 active IMP versus placebo. Patients withdrawn from the study before administration of the last planned dose will not be replaced.

    The patients will be treated as outpatients in clinics in 10–15 study sites in 2 countries.
    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 Yes
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Cohort Study
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Yes
    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
    last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    Normal standard 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 Decision2009-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-23
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