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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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:2008-007510-30
    Sponsor's Protocol Code Number:ARRAY 797-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-29
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2008-007510-30
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY
    A.4.1Sponsor's protocol code numberARRAY 797-201
    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 SponsorArray BioPharma Inc.
    B.1.3.4CountryUnited States
    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 nameARRY-371797
    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.3.9.1CAS number 765914-60-1
    D.3.9.2Current sponsor codeARRY-371797
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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
    ANKYLOSING SPONDYLITIS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To compare the efficacy of ARRY-371797 (200 mg q12h and 400 mg q24h) versus placebo in patients with active ankylosing spondylitis (AS).
    •To evaluate the safety of ARRY-371797 in patients with active AS.
    E.2.2Secondary objectives of the trial
    •To evaluate the exposure of ARRY-371797 and a metabolite (AR00333953) in plasma after the administration of ARRY-371797.
    •To evaluate the effect of two dose regimens of ARRY-371797 versus placebo on measures of disease activity.
    •To evaluate the pharmacodynamic effects of two dose regimens of ARRY-371797 on circulating levels of exploratory markers of disease activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has provided written informed consent and is willing to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures;
    2. Is at least 18 years of age;
    3. Diagnosed with ankylosing spondylitis according to the Modified New York Criteria (1984);
    4. Total Back Pain Score measured by 10-point numerical rating scale (NRS) ≥ 4 at Screening and at Baseline;
    5. Clinically active axial disease characterized by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at Screening and at Baseline despite concurrent treatment with conventional therapy (e.g., NSAIDs, glucocorticoids or DMARDs);
    6. Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive ≥ 2 full weeks of continuous treatment with NSAIDs because of intolerance;
    7.If previously treated with a biological agent must NOT have failed due to lack of efficacy, and has completed the following washouts (calculated from first dose of Study Drug):
    a. Within 4 weeks of first dose of Study Drug: etanercept (Enbrel®), anakinra (Kineret®);
    b. Within 8 weeks of first dose of Study Drug: infliximab (Remicade®), adalimumab (Humira®);
    8. Has completed a 4-week washout period (calculated from first dose of Study Drug), if treated with any of the following therapies:
    a. Any experimental therapy (within or outside a clinical trial setting);
    b. Intramuscular or intravenous corticosteroids;
    c. Other—herbal medications; immunization with any live virus vaccination (e.g., FluMist®).
    9. Patients may continue on stable background therapy for AS (doses should be stable for at least 4 weeks prior to the first dose of Study Drug) only if it is included in the following list:
    a. Non-investigational NSAIDs and/or COX-2 inhibitors;
    b. DMARDs—methotrexate (≤ 25 mg/week), sulfasalazine (≤ 3 gm/day), leflunomide (≤ 20 mg/day);
    c. Hydroxychloroquine (≤ 400 mg/day);
    d. Low-dose oral corticosteroids (≤ 10 mg prednisone or equivalent per day);
    e. Opioid analgesics (≤ 30 mg oral morphine or equivalent per day);
    f. Acetaminophen (paracetamol) ≤ 4000 mg/day (4 g/day);
    g. Aspirin if taken for non-arthritic reasons (≤ 325 mg/day).
    10. If female participant, has met either criterion “a” or “b” below:
    a. Is of non-childbearing potential (amenorrheic for at least 2 years, or had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening);
    • All other female patients (including those with tubal ligation) will be considered of childbearing potential.
    b. Is of childbearing potential and willing to use the acceptable methods of contraception and abide by the timelines of each method.
    11. If male participant, must be willing to use the acceptable methods of contraception and abide by the timelines.
    E.4Principal exclusion criteria
    1. Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments;
    2. Previously treated with IV immunoglobulins within 6 months of first dose of Study Drug;
    3. History of:
    a. Significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or dermatological disease;
    b. Significant cardiac disease, myocardial infarction within 6 months of screening, unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III-IV), known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia;
    c. Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 6 months of first dose of Study Drug;
    d. Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known vaccination with the Bacillus Calmette - Guerin vaccine (BCG). Prior history of BCG with positive reaction to PPD will require follow-up negative chest X-ray;
    e. Significant trauma or major surgery within 8 weeks of first dose of Study Drug;
    f. Alcohol abuse with less than 12 months of sobriety, or any drug abuse within 3 years of first dose of Study Drug;
    g. Cancer unless in complete curative remission for ≥ 5 years, excluding patients with adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ;
    h. Participation in another clinical trial within 4 weeks of Screening.
    4. Presenting with any of the following:
    a. Severe psychological illness or any condition which will interfere with the patient’s ability to understand and/or comply with the requirements of the study;
    b. Any condition possibly affecting oral drug absorption (e.g., gastrectomy, malabsorption, Crohn’s disease or clinically significant diabetic gastroenteropathy);
    c. A documented body temperature ≥ 37.5˚C (99.5 ˚F) at Screening and Baseline (e.g., pre-dose on Day 1);
    d. An infection with human immunodeficiency virus (HIV) or hepatitis B or C;
    e. Any clinically significant active infection including herpes lesions;
    f. A confirmed mean of the screening triplicate QTc interval > 450 ms by Fridericia’s formula as calculated by the site.
    g. Total fusion of the spine
    5. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments at Screening:
    a. Hgb ≤ 10 g/dL or Hct ≤ 32%;
    b. Absolute WBC count ≤ 3.0 × 109/L (3000/mm3);
    c. Neutrophil count ≤ 1.2 × 109/L (1200/mm3);
    d. Platelet count ≤ 100 × 109/L (100,000/mm3);
    e. AST (aspartate aminotransaminase) or ALT (alanine aminotransaminase) ≥ 1.2 × upper limit of normal (ULN);
    f. Total bilirubin ≥ 1.5 × ULN;
    g. Alkaline phosphatase ≥ 1.5 × ULN;
    h. Albumin ≤ 3.5 g/dL (35 g/L);
    i. Serum creatinine ≥ 1.2 × ULN;
    j. Thyroid-stimulating hormone (TSH) ≥ 1.2 × ULN unless clinically euthyroid and receiving a stable dose of thryroxine.
    6. Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study;
    7. Pregnant or breastfeeding patients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be ASAS 20 response at Week 12
    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 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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    multi-center
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) 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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 126
    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 Decision2009-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-07-08
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