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    Summary
    EudraCT Number:2008-006786-92
    Sponsor's Protocol Code Number:AC-058B201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-26
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-006786-92
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis
    A.4.1Sponsor's protocol code numberAC-058B201
    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.IMP: 3
    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 number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing-remitting multiple sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 at least one of three doses of ACT-128800 as compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS) on the cumulative number of new gadolinium-enhancing lesions per patient, recorded on T1-weighted MRI scans at Weeks 12, 16, 20, and 24 after study drug initiation.
    E.2.2Secondary objectives of the trial
    • To evaluate the effects of ACT-128800 on the annualized confirmed relapse rate within 24 weeks of study drug initiation.
    • To evaluate the effects of ACT-128800 on time to first confirmed relapse within 24 weeks of study drug initiation.
    • To evaluate the safety and tolerability of ACT-128800.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ancillary studies included in this protocol, but only implemented at selected sites:
    - Exploration of echocardiographic parameters
    - Exploration of ophtalmological parameters by Optical Coherence Tomography (OCT)

    Additional ancillary studies may be conducted under dedicated sub-study protocols submitted and implemented only at selected sites.
    E.3Principal inclusion criteria
    1. Males and females aged 18 to 55 years (inclusive).
    2. Women of childbearing potential must:
    • Have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
    • Agree to use two methods of contraception from the screening visit until 8 weeks 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.
    - Group 2: Condoms, diaphragm or cervical cap, all in combination with spermicide.
    Abstention and rhythm methods are not acceptable methods of contraception.
    3. Presenting with a diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS).
    4. Ambulatory and with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5 (inclusive).
    5. With at least one of the following characteristics of RRMS:
    • One or more documented relapse(s) within 12 months prior to the screening visit,
    • Two or more documented relapses within 24 months prior to the screening visit,
    • At least one gadolinium-enhancing lesion detected on T1-weighted MRI at the Screening visit (based on central reading).
    6. In a stable clinical condition:
    • Without a clinical exacerbation of MS for at least 30 days prior to randomization (exacerbation of MS is defined as one or more new symptom(s), or worsening of existing symptoms, not associated with fever or infection, and lasting for at least 24 hours).
    7. Signed informed consent prior to initiation of any study mandated procedure.
    E.4Principal exclusion criteria
    1. Breast feeding women.
    2. A diagnosis of MS categorized as primary progressive or secondary progressive or progressive relapsing.
    3. Treatment with
    Within 30 days prior to randomization:
    • Systemic corticosteroids or adrenocorticotropic hormone (ACTH)
    • Treatment with β-blockers, diltiazem, verapamil, or digoxin or QT-prolonging drugs (as listed in Appendix 9), for any indication
    Within 3 months prior to randomization:
    • Interferon or glatiramer acetate
    • Systemic immunosuppressive treatment (e.g., cyclosporine, sirolimus, mycophenolic acid)
    • Vaccination with live vaccines
    • Plasma exchange (plasmapheresis, cytapheresis)
    • Treatment with an investigational drug (within 3 months or 5 half-lives of the drug, whichever is longer), except biological agents (see below)
    Within 6 months prior to randomization:
    • Azathioprine or methotrexate
    • Natalizumab (or previous failure to natalizumab)
    • Intravenous immunoglobulin
    • Non-lymphocyte-depleting biologic agents (e.g., daclizumab)
    At any time prior to randomization:
    • Cyclophosphamide, mitoxantrone, or cladribine
    • Lymphocyte-depleting biologic agents such as alemtuzumab or rituximab
    4. Patient currently treated for an autoimmune disorder other than MS.
    5. Contraindications for MRI such as:
    • Pacemaker, any metallic implants such as artificial heart valves, aneurysm/vessel clips and any metallic material in high-risk areas
    • Known allergy to any gadolinium contrast agent
    • Severe renal insufficiency defined as a creatinine clearance < 30 mL/min according to the Cockroft-Gault formula
    • Claustrophobia
    6. Ongoing bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests.
    7. Congenital or acquired severe immunodeficiency or known human immunodeficiency virus (HIV) infection.
    8. Negative antibody test for varicella-zoster virus at screening.
    9. History or presence of malignancy (except for surgically excised basal or squamous cell skin lesions), lymphoproliferative disease, or history of total lymphoid irradiation or bone marrow transplantation.
    10. Poorly controlled type I or type II diabetes.
    11. Macular edema or diabetic retinopathy (as confirmed within 30 days prior to randomization).
    12. History of clinically significant drug or alcohol abuse.
    13. Any of the following cardiovascular conditions:
    • Resting heart rate (HR) < 55 bpm, as measured by the pre-randomization ECG on Visit 3 (Day 1).
    • History or presence of ischemic heart disease.
    • History of or current valvular heart disease.
    • History of or current heart failure
    • History or presence of rhythm disorders (e.g., sino atrial heart block, sick sinus syndrome, second or third-degree atrioventricular (AV) block, ventricular arrhythmias, symptomatic bradycardia, atrial flutter or atrial fibrillation) or ongoing anti-arrhythmic therapy.
    • QTc > 470 msec (females) and QTc > 450 msec (males) in any of the ECGs performed at Screening, Baseline, or Day 1 prior to randomization.
    • History of syncope.
    • Uncontrolled arterial hypertension.
    14. Any of the following pulmonary conditions:
    • Moderate or severe bronchial asthma or chronic obstructive pulmonary disease (COPD) stage II–IV, i.e., forced expiratory volume in 1 second (FEV1) < 70% of forced vital capacity (FVC), i.e., FEV1/FVC ratio < 0.7.
    • History of pulmonary fibrosis (scarring of the lung), pulmonary Langerhans’cell histiocytosis.
    • History of tuberculosis, chest X-ray findings at screening or within the previous 3 months, suggestive of active or latent tuberculosis, or absence of a negative test result for tuberculosis at screening based on an interferon gamma release assay.
    15. Abnormal liver function tests as defined by elevations of ALT/SGPT or AST/SGOT > 2-fold the upper limit of the normal range (ULN) or total bilirubin > 1.5-fold ULN.
    16. Any of the following abnormal laboratory values:
    • White blood cell (WBC) count < 3,500/μL
    • Hemoglobin (Hb) < 10 g/dL
    • Lymphocyte count < 1,000/μL
    • Platelets < 100,000/μL
    17. Known allergy to any of the study drug excipients.
    18. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the study.
    19. Patients who are confined by order of either judicial or administrative authorities.
    20. Patients unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits or known likelihood of not completing the study including mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Cumulative number of new gadolinium-enhancing lesions per patient recorded on T1-weighted MRI scans at Weeks 12, 16, 20, and 24 after study drug initiation.

    This endpoint is derived by summing the observed numbers of new gadolinium-enhancing lesions on MRI scans at Weeks 12, 16, 20, and 24. A reduction from 8 to 4 (50% decrease compared to placebo) in the mean cumulative number of the lesions is to be detected.

    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
    dose finding, 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 years1
    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 years1
    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 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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 460
    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 Decision2009-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-17
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