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    Summary
    EudraCT Number:2008-001443-19
    Sponsor's Protocol Code Number:AC-058A200
    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:2008-07-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-001443-19
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasis
    A.4.1Sponsor's protocol code numberAC-058A200
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 nameACT-128800
    D.3.2Product code ACT-128800
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACT-128800
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 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 nameACT-128800
    D.3.2Product code ACT-128800
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeACT-128800
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe chronic plaque 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 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
    • To demonstrate the efficacy of ACT-128800 20 mg once daily on Psoriasis Area and Severity Index (PASI) at Week 6 in subjects with moderate to severe chronic plaque psoriasis.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of ACT-128800 20 mg once daily for 6 weeks in subjects with moderate to severe chronic plaque psoriasis.
    • To investigate the pharmacokinetics and pharmacodynamics of ACT-128800 in subjects with moderate to severe chronic plaque psoriasis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged 18 to 60 years (inclusive).
    2. For female subjects, a woman of childbearing potential must:
    • have a negative serum pregnancy test at screening and a negative urine pregnancy test at randomization (before the first study drug intake).
    • agree to use two methods of contraception from the screening visit until 2 months after study drug discontinuation.
    Of the two contraceptive methods, one must be from Group 1, and one must be from Group 2, defined as follows:
    Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation), or partner’s sterilization (vasectomy). If a hormonal contraceptive will be chosen from this group, it must have been taken for at least 1 month prior to randomization (i.e., Visit 2).
    Group 2: Condoms, diaphragm or cervical cap, all in combination with spermicide.
    Abstention and rhythm are not acceptable methods of contraception.
    A woman is considered to be of childbearing potential unless she meets at least one of the following criteria:
    • Previous bilateral salpingo-oophorectomy, or hysterectomy.
    • Premature ovarian failure confirmed by a specialist gynecologist.
    • Age >= 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening, and a serum follicle-stimulating hormone (FSH) level of > 40 IU/L at screening.
    • Age >= 55 years and treated with HRT prior to screening with appropriate medical documentation of spontaneous amenorrhea for at least 24 consecutive months.
    3. Moderate to severe plaque psoriasis with body surface area (BSA) involvement > 10% and PASI score > 10, which is stable for at least 3 months, requires systemic treatment, and for which treatment in a placebo-controlled study of an investigational drug can be justified.
    4. Signed informed consent form prior to initiation of any study-mandated procedure.
    E.4Principal exclusion criteria
    1. Breast-feeding women.
    2. Generalized erythrodermic, generalized pustular psoriasis (von Zumbusch), guttate, and palmo-plantar psoriasis.
    3. Treatment with:
    • Ultraviolet B (UVB) therapy, psoralen-ultraviolet-light (PUVA) therapy and topical treatments for psoriasis other than emollients within 1 month prior to start of study drug.
    • Oral retinoids, methotrexate, cyclosporine and systemic corticosteroids within 1 month prior to start of study drug.
    • Approved immunosuppressive or immunomodulatory biologic agents (e.g., infliximab, etanercept, alefacept, efalizumab, adalimumab) within 3 months prior to start of study drug.
    • Investigational non lymphocyte-depleting biologic agents (recombinant proteins or monoclonal antibodies) within 6 months prior to start of study drug or lymphocyte-depleting biologic agents at any point in time.
    • Other systemic immunosuppressive drugs (e.g., mycophenolic acid, sirolimus) within 3 months prior to start of study drug.
    • Treatment with another investigational drug within 3 months prior to start of study drug.
    • Vaccination with live vaccines within 3 months prior to start of study drug.
    • Treatment with β-blockers, diltiazem, verapamil, digoxin, amiodarone, and lithium (for any indication) within 1 month prior to start of study drug.
    4. Subjects currently treated for autoimmune disorders other than psoriasis.
    5. Ongoing bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests.
    6. Congenital or acquired severe immunodeficiency or known human immunodeficiency virus (HIV) infection.
    7. History or presence of malignancy (except for basal or squamous cell skin lesions which have been surgically excised), lymphoproliferative disease and subjects who received total lymphoid irradiation or bone marrow transplantation.
    8. Poorly controlled type I or II diabetes.
    9. History or presence of macular edema or diabetic retinopathy (as confirmed by fundoscopy within 28 days prior to randomization).
    10. Any of the following cardiovascular conditions:
    • Resting heart rate (HR) < 60 bpm.
    • PR > 180 ms.
    • Symptomatic ischemic heart disease.
    • History of valvular heart disease.
    • History of heart failure.
    • History or presence of rhythm disorders (e.g., sino atrial heart block, second degree atrioventricular [AV] block, third degree AV-block, sick sinus syndrome, symptomatic bradycardia, atrial flutter or atrial fibrillation) or subjects who receive anti-arrhythmic therapy.
    • History of syncope.
    • Arterial hypertension uncontrolled by medications.
    11. Any of the following pulmonary conditions:
    • Moderate and severe bronchial asthma or chronic obstructive pulmonary disease (COPD) stage II–IV (i.e., forced expiratory volume in 1 second [FEV1] < 70%).
    • History of pulmonary fibrosis (scarring of the lung), pulmonary Langerhans’ cell histiocytosis.
    • History of tuberculosis, or positive chest X-ray at screening or within the previous 3 months, suggestive of active or latent tuberculosis.
    12. Abnormal liver function tests as defined by persisting elevations of alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) or aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or total bilirubin > 2-fold the upper limit of the normal range (ULN).
    13. Any of the following abnormal laboratory values:
    • Hemoglobin (Hb) < 10g/dL.
    • White blood cells (WBC) count < 3,500/μL.
    • Lymphocyte count < 1000 /μL.
    • Platelets < 100,000/μL.
    • Serum creatinine > 1.7 mg/dL (150 μmol/L).
    14. History of clinically significant drug or alcohol abuse.
    15. Known allergy to any of the study drug excipients.
    16. Any other clinically relevant medical or surgical condition which in the opinion of the investigator would put the subject at risk by participating in the study.
    17. Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits or likelihood of not completing the study including mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and subjects who are confined by order of either judicial or administrative authorities.
    E.5 End points
    E.5.1Primary end point(s)
    • PASI percent change relative to baseline (BL) at Week 6 visit.
    The difference to be detected is a placebo-corrected mean decrease of 30 units. Percentage change of PASI is expected to be normally distributed with a standard deviation (SD) of 29%.
    For each of the following criteria, within the cohort of active-treated subjects, the primary endpoint will be further explored in the two subsets of subjects who fulfill (Group A) or do not fulfill (Group B):
    – Peripheral total lymphocyte count ≤ 0.8 10^9/L at Week 6 visit, 6 hours post-dose.
    – Reduction of peripheral total lymphocyte count by ≥ 80% compared to baseline at Week 6 visit, 6 hours post-dose.
    – Peripheral total lymphocyte count ≤ 0.5 10^9/L at Week 6 visit, 6 hours post-dose
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 60
    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)
    N/A- Expected normal treatment
    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 Decision2008-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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