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    Summary
    EudraCT Number:2019-001185-15
    Sponsor's Protocol Code Number:SynAct-CS002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2019-001185-15
    A.3Full title of the trial
    A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease
    Et dobbelt-blind, multi-center, todelt, randomiseret, placebokontrolleret studie af sikkerhed, tolerabilitet og effekt af 4 ugers behandling med AP1189 til patienter med tidlig leddegigt og aktiv led sygdom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).
    The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect
    Et dobbeltblindt forsøg i to dele hos personer med aktiv, nyopdaget leddegigt. Forsøget foregår på flere hospitaler. For bedre at kunne vurdere den aktive studiemedicin AP1189s virkningsmekanisme, sammenlignes AP1189 med et inaktivt stof (placebo). Hvilken behandling personen skal have afgøres ved tilfældig distribution (randomisering).
    Formålet med forsøget er at undersøge det nye lægemiddels sikkerhed, hvor godt det tåles samt dets effekt
    A.3.2Name or abbreviated title of the trial where available
    SynAct-CS002
    A.4.1Sponsor's protocol code numberSynAct-CS002
    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 SponsorSynAct Pharma ApS
    B.1.3.4CountryDenmark
    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 supportSynAct Pharma ApS
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynAct Pharma ApS
    B.5.2Functional name of contact pointCSO
    B.5.3 Address:
    B.5.3.1Street AddressDronninggårds Allé 136
    B.5.3.2Town/ cityHolte
    B.5.3.3Post code2940
    B.5.3.4CountryDenmark
    B.5.4Telephone number004545475020
    B.5.5Fax number004545475001
    B.5.6E-mailtenj@synactpharma.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 AP1189
    D.3.4Pharmaceutical form Powder for oral suspension
    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.3.8INN - Proposed INNNot applicable
    D.3.9.2Current sponsor codeAP1189
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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) 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 No
    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 placeboPowder for oral suspension
    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
    rheumatoid arthritis
    Leddegigt
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Primary safety Objective:
    •To compare the safety of AP1189 against placebo by evaluating AEs, SAEs, and laboratory abnormalities.

    Primary efficacy Objective:
    •Effect of AP1189 vs. placebo in subjects with severe active RA (CDAI > 22), undergoing up-titration with MTX, by showing a change in CDAI from severe (CDAI > 22) to moderate (CDAI ≤ 22) after 4 weeks treatment compared to baseline.
    E.2.2Secondary objectives of the trial
    Secondary efficacy Objectives:
    •Proportion of subjects achieving a reduction of more than 10 (ten) swollen and/or tender joints at week 4 compared to baseline
    •Proportion of subjects achieving a change in CDAI score at week 4 compared to baseline
    o Proportion of subjects with a 5-point decrease
    o Proportion of subjects with a 10-point decrease
    o Proportion of subjects with a 15-point decrease
    •Proportion of subjects achieving a change in value to ≤ 3.2 as measured by DAS28 at week 4 compared to baseline
    •Change in subject-reported HAQ-DI at week 4 compared to baseline
    •Change in subject-reported fatigue using FACIT-Fatigue at week 4 compared to baseline
    •Proportion of subjects achieving American College of Rheumatology (ACR) response assessed by ACR20, ACR50, and ACR70
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Effect of AP1189 compared to placebo on joint structures and inflammation as assessed by synovial biopsy at baseline and after 4 weeks treatment (only Part 2 at selected sites).
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. The following are requirements for entry into the study.
    1.Written informed consent has been obtained prior to initiating any study specific procedures
    2.Male and female subjects, 18 to 85 years of age
    3.Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria
    4.Arthritis with joint swelling and tenderness of a minimum of three joints out of 68 joints tested
    5.Candidate for MTX treatment
    6.Is about to begin treatment with MTX
    7.Tested positive for anti-CCP or RF
    8.Severe active RA (CDAI > 22) at screening and baseline
    9.Negative QFG-IT (Mantoux test can be used if QFG-IT is not possible)
    10.Subjects should be able to complete (read and write) the PRO questionnaires
    11.Females of child-bearing potential may only participate if using reliable means of contraception (for detailed information see section 17.8) or are post-menopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial). Surgically sterilized women at least 6 months prior to screening
    12.Females of childbearing potential must have a negative pregnancy test at screening and baseline.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria are not eligible for participation in the study:
    1.Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry
    2.Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
    3.Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren syndrome with RA is allowable
    4.Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound
    5.Prior history of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
    6.Subjects with fibromyalgia
    7.Initiation or change in dose for NSAIDs (including low-dose aspirin and COX-2 inhibitors) within 2 weeks prior to dosing with the IMP
    8.Corticosteroids are prohibited within 2 weeks prior to screening (and during the entire treatment period and until the final visit (Visit 7)
    9.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
    10.Have prior renal transplant, current renal dialysis or severe renal insufficiency (determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault formula of ≤30 ml/min/1,73m² calculated by the local lab)
    11.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
    12.Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
    13.Pregnant women or nursing (breastfeeding) mothers
    14.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
    15.Neuropathies or other painful conditions that might interfere with pain evaluation
    16.Body weight of >150 kg.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint:
    The safety of AP1189 against placebo by evaluating adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities.

    Primary Efficacy Endpoint:
    The change in CDAI after 4 weeks of treatment compared to baseline will be evaluated by assessing the following, by treatment group:
    •Mean change in CDAI from baseline to week 4
    •Proportion of subjects with a change in CDAI score from severe (CDAI > 22) to moderate (CDAI ≤ 22) at week 4 compared to baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AE and SAE will be registered at all visits and the biochemistry blood samples will be taken at all visits.

    The CDAI will be scored at screening, baseline, after 2 weeks and 4 weeks treatment and at Visit 7.
    E.5.2Secondary end point(s)
    The effects of AP1189 against placebo will be evaluated by assessing the following by treatment group:
    •Proportion of subjects achieving a reduction of more than 10 (ten) swollen and/or tender joints (SJC and TJC, summarized) at week 4 compared to baseline
    •Proportion of subjects achieving a change in CDAI score at week 4 compared to baseline
    oProportion of subjects with a 5-point decrease
    oProportion of subjects with a 10-point decrease
    oProportion of subjects with a 15-point decrease
    •Proportion of subjects achieving a change in DAS28 from DAS28 >3.2 to DAS28 ≤ 3.2 at week 4 compared to baseline
    •Change of HAQ-DI at week 4 compared to baseline
    •Change of FACIT-Fatigue at week 4 compared to baseline
    •Proportion of subjects achieving ACR response assessed by ACR 20, ACR 50, and AC70
    E.5.2.1Timepoint(s) of evaluation of this end point
    The CDAI will be scored at screening, baseline, after 2 weeks and 4 weeks treatment and at Visit 7.

    The DAS28 will be scored at baseline, after 2 weeks and 4 weeks treatment and at Visit 7.

    HAQ-DI will be scored at baseline, after 2 weeks and 4 weeks treatment and at Visit 7.

    FACIT-Fatigue will be scored at baseline, after 2 weeks and 4 weeks treatment and at Visit 7.


    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Multi-centre and two-part trial
    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 trial3
    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 concerned3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Moldova, Republic of
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 135
    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)
    No
    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 Decision2019-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-16
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