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    Summary
    EudraCT Number:2020-003955-14
    Sponsor's Protocol Code Number:AMT-101-204
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-003955-14
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy
    A.4.1Sponsor's protocol code numberAMT-101-204
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorApplied Molecular Transport 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 supportApplied Molecular Transport Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApplied Molecular Transport Inc.
    B.5.2Functional name of contact pointClincial Trial AMT-101-204
    B.5.3 Address:
    B.5.3.1Street Address1 Tower Place, Suite 850
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16503804706
    B.5.6E-mailCT101@appliedmt.com
    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.3.2Product code AMT-101
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    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 codeAMT-101
    D.3.9.3Other descriptive nameAMT-101
    D.3.9.4EV Substance CodeSUB207239
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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 placeboGastro-resistant tablet
    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
    Active Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis is a chronic inflammatory disease characterised by joint swelling, joint tenderness, and destruction of synovial joints, leading to severe disability and premature mortality.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of 12 weeks of daily oral AMT-101 in patients with active RA who have an inadequate response to anti-TNF therapy
    E.2.2Secondary objectives of the trial
    • To assess the biologic activity of 12 weeks of daily oral AMT-101 by changes in the DAS-28 (CRP), SDAI and CDAI, and ACR 20, 50, 70
    • To examine the pharmacokinetic and pharmacodynamic effects of AMT-101
    • To examine the immunogenicity of AMT-101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female and male patients aged ≥18 and <75 years old, inclusive at the time of informed consent.
    • Body weight of ≥ 45 kilograms (kg) and ≤100 kg and must have a body mass index (BMI) within the range of 18.5 – 34.9 kg/m2.
    • Diagnosed with RA under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria for at least 6 months before.
    • Patients must be taking anti-TNF biologic treatment under approved dosage and administration for ≥12 weeks and < 3 years but only had an inadequate response according to Investigator judgement a) DAS28(CRP) > 4.4 and ≤ 5.1 or b) DAS28(CRP) ≥ 3.2 and ≤ 5.1 plus at least 2/28 swollen and tender joints (except joint surgery).
    • History of biologics treatment should be limited to anti-TNF agents among adalimumab, infliximab, golimumab, etanercept, certolizumab (including biosimilars).
    • Two or more swollen and tender joints in the Screening Phase (out of 28 joints).

    E.4Principal exclusion criteria
    • Any history or complication of an inflammatory arthritic disorder other than RA
    • Any history of Inflammatory Bowel Disease (Ulcerative Colitis or Crohn’s disease)
    • Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV.
    • Received IV Immunoglobulin (IV Ig) preparations or blood products within 24 weeks before starting the study treatment.
    • Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive a live vaccine during the study
    • Current therapy with any non-MTX synthetic small-molecule DMARD (including but not limited to sulfasalazine, azathioprine, hydroxychloroquine, and/or leflunomide) for at least 1 month prior to the Screening Visit or concomitantly during the trial.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of patients with treatment-emergent adverse events (TEAEs), SAEs, and discontinuation due to TEAEs
    • Assessment of physical examinations, laboratory parameters, vital signs, and ECGs
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    • Efficacy: Change over time in:
    - DAS-28(CRP), SDAI and CDAI, ACR 20, 50,70
    - Proportion of patients with DAS-28(CRP) less than 2.6
    - Proportion of patients with DAS-28(CRP) less than 3.2
    - Proportion of patients with Boolean Remission
    - Change in acute phase reactants (CRP, ESR)
    • Pharmacokinetics: Change in AMT-101 and Serum IL-10 levels
    • Pharmacodynamics: Change in serum IL-1Ra
    • Immunogenicity: Incidence of anti-AMT-101 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Efficacy: at treatment completion and 4 weeks post completion
    • Pharmacokinetics: baseline, Day 1- at 8 and 24 hrs. and at weeks 2, 4, 8, and 12
    • Pharmacodynamics: from baseline to Day 1 at 4, 8, and 24 hr., and at weeks 2, 4, 8, 12, and 16
    • Immunogenicity: baseline and weeks 12 and 16
    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 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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LVLS
    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 months11
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state20
    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)
    None
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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