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    Summary
    EudraCT Number:2021-006665-38
    Sponsor's Protocol Code Number:RBM-001-RA002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-006665-38
    A.3Full title of the trial
    APPRAIS - A 24-week multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the possible side and the efficacy of orally administered Rabeximod when taken in combination with methotrexate compared with Methotrexate only in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate
    A.3.2Name or abbreviated title of the trial where available
    APPRAIS
    A.4.1Sponsor's protocol code numberRBM-001-RA002
    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 SponsorCyxone AB
    B.1.3.4CountrySweden
    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 supportCyxone AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCyxone AB
    B.5.2Functional name of contact pointCarl Magnus Högerkorp- CEO
    B.5.3 Address:
    B.5.3.1Street AddressHyllie Boulevard 34
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code215 32
    B.5.3.4CountrySweden
    B.5.4Telephone number+46708882172
    B.5.6E-mailcarl.hogerkorp@cyxone.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.3.1Product nameRabeximod
    D.3.2Product code OXY-001
    D.3.4Pharmaceutical form Capsule
    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 INNRabeximod
    D.3.9.1CAS number 872178-65-9
    D.3.9.2Current sponsor codeOXY-001
    D.3.9.4EV Substance CodeSUB218407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboCapsule
    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, moderate to severe rheumatoid arthritis with inadequate response to methotrexate
    E.1.1.1Medical condition in easily understood language
    Active rheumatoid arthritis which is not adequately responding to methotrexate
    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
    -To assess the efficacy (measured by DAS28-CRP) of rabeximod compared to placebo as add-on therapy in patients with active, moderate to severe RA with inadequately controlled disease
    E.2.2Secondary objectives of the trial
    -To assess the efficacy (measured by
    ACR20/ACR50/ACR70) of rabeximod compared to placebo as add-on therapy in patients with active, moderate to severe RA with inadequately controlled disease.
    -To assess the safety and tolerability of rabeximod compared to placebo as add-on therapy in patients with active, moderate to severe RA with inadequately controlled disease.
    -To assess the effect of rabeximod compared to placebo as add-on therapy in patients with active, moderate to severe RA with inadequately controlled disease on health-related quality of life (HRQoL).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must give written informed consent before any trial-related assessment is performed.
    2.Male or non-pregnant, non-lactating female patients at least 18 years of age. Women of childbearing potential will be screened after a confirmed menstrual period.
    3.Established RA diagnosis according to the 2010 ACR/EULAR classification or the 1987 criteria.
    4.Active RA (DAS28-CRP score ≥3.2) with at least 6 swollen joints and 6 tender joints using the 28 joint count.
    5.hsCRP levels ≥5 mg/L at screening.
    6.Patients must have taken oral or parenteral MTX 7.5-25 mg/week continuously for at least 12 weeks, with at least 6 weeks of stable dose prior to screening and throughout the duration of the trial.
    7.Patients taking systemic corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 4 weeks before screening.
    8.Patients taking hydroxychloroquine must be on a stable dose for at least 8 weeks before screening
    9.Patients who are regularly taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or COX-2 inhibitors or paracetamol/acetaminophen as part of their RA therapy are required to be on a stable dose for at least 4 weeks before screening.
    E.4Principal exclusion criteria
    1.RA patients functional status class IV classified according to the ACR 1991 revised criteria.
    2.Patients taking high potency opioid.
    3.Use of strong CYP3A4 inhibitors within 2 weeks prior to screening and during the trial.
    4.Previous long-term use of TNFα, T-cell co stimulation inhibition, IL-6 receptor blockers, anti B-cell therapy and Janus Kinase inhibitors.
    5.Any therapy by intra-articular and intramuscular injections within 4 weeks before screening.
    6.Treatment with hydroxychloroquine at a dose >5 mg/kg/day for >5 years
    7.Pregnant or nursing women.
    8.Women of child-bearing potential unless:
    a) Women who observe total abstinence when this is in line with the preferred and usual lifestyle of the patient during the trial participation until 58 days from the last dose of the study drug.
    b) Women whose partners have been sterilized by vasectomy or other means.
    c) Women using a highly effective method of birth control.
    9.Male patients must be using two acceptable methods of contraception for the entire duration of the trial, up to the End of Treatment visit and refrain from fathering a child in the at least 118 days months following the last IMP administration. Vasectomised partner is a highly effective birth control method.
    10.Inflammatory diseases other than RA that might confound the evaluation of the benefit of rabeximod therapy.
    11.Laboratory evidence of underlying metabolic, haematologic, renal, hepatic, pulmonary, neurologic, endocrine, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk.
    12.Recent myocardial infarction, coronary revascularization, or percutaneous angioplasty; acute coronary syndrome; chronic uncompensated heart failure or New York Heart Association Functional Class III or IV; left ventricular assist devices; implanted defibrillators.
    13.History of clinically significant alcoholic liver disease or liver.
    14.History of severe chronic renal insufficiency, or patients with one kidney, or a creatinine level exceeding 1.5 mg/dL.
    15.Screening total whole blood cell count <3,000/μL, or platelets <100,000/μL or neutrophils <1,500/μL or hemoglobin <8.5 g/dL.
    16.Active systemic infections during the last two weeks prior to screening.
    17.Infection with tuberculosis, HIV, hepatitis B or hepatitis C by a positive test at screening:
    a) Patients with positive or indeterminate tuberculosis test at screening can be eligible if they have all of the following:
    - No clinical features of active tuberculosis.
    - Completed appropriate treatment for active or latent tuberculosis.
    - No history of re-exposure since their treatment was completed.
    - Chest x-ray with no evidence of active tuberculosis.
    b) If the HIV test result is positive, the patient cannot be enrolled.
    c) At Screening:
    - If the HBsAg test result is positive, the patient cannot be enrolled.
    - If a patient has results of HBsAg (negative), HBsAb (negative or positive), and HBcAb (positive), a hepatitis B virus (HBV) DNA test will be performed at Screening.
    •If the HBV DNA test result is positive, the patient cannot be enrolled.
    •If the HBV DNA test result is negative and the patient does not have any evidence of liver cirrhosis, the patient can be enrolled.
    d) At Screening:
    - If the HCV RNA test result is positive, the patient cannot be enrolled.
    - If the HCA result is positive and HCV RNA test result is negative, the patient can be enrolled as long as the patient does not have liver cirrhosis and achieved a SVR for at least 12 weeks after completing the hepatitis C infection treatment.
    18.History of a major organ transplant or haematopoietic stem cell/marrow transplant.
    19.History of major surgery within 3 months prior to screening or planned major surgery during the trial.
    20.History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years.
    21.Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the patient unsuitable for the trial.
    22.Inability or unwillingness to undergo repeated venipuncture.
    23.Treatment with intravenous antibiotics within 1 month prior to screening; treatment with oral antibiotics within 2 weeks prior to screening; or current evidence of a clinically significant active infection.
    24.A live virus vaccination within the 90 days prior to screening.
    25.Any medical or psychiatric condition which would preclude the participant from adhering to the protocol or completing the trial per protocol.
    26.Donation or loss of 400 mL or more of blood within 8 weeks before dosing.
    27.History or evidence of ongoing alcohol or drug abuse.
    28.Previous exposure to rabeximod.
    29.Use of any investigational drug at the time of randomization, or within 30 days or 5 half-lives of randomization, whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in DAS28-CRP at Week 16
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    -Change from baseline in DAS28-CRP at Week 12

    Other Secondary Efficacy Endpoints
    -Change from baseline in DAS28-CRP at Week 4, 8, 20, and 24
    -Clinical response to treatment based on an improvement of DAS28-CRP of >1.2 at Weeks 4, 8, 12, 16, 20, and 24 as compared to baseline
    -Clinical response to treatment based on DAS28-CRP <3.2 at Weeks 12, 16, and 24
    -Clinical remission based on DAS28-CRP <2.6 at Weeks 12, 16, and 24
    -Clinical response to treatment according to ACR20, ACR50 and ACR70 individual improvement in disease activity at Week 12, 16, and 24 as compared to baseline.
    A patient will be considered a responder according to the ACR criteria if he/she has at least:
    -20%, 50% or 70% improvement in tender 28-joint count
    -20%, 50% or 70% improvement in swollen 28-joint count
    -and 20%, 50% or 70% improvement in at least 3 of the following 5 measures:
    1.Patient’s assessment of arthritis pain (visual analogue scale [VAS] 100 mm)
    2.Patient’s global assessment of disease activity (VAS 100 mm)
    3.Physician’s global assessment of disease activity (VAS 100 mm)
    4.Patient self-assessed disability (HAQ-DI) score
    5.Acute phase reactant (hsCRP)
    -ACR components at Weeks 12, 16 and 24
    oChange from baseline in tender 28-joint count
    oChange from baseline in swollen 28-joint count
    oChange from baseline in hsCRP
    oChange from baseline in erythrocyte sedimentation rate (ESR)
    -Change from baseline in HAQ-DI at Weeks 16 and 24
    -Patient’s assessment of arthritis pain (VAS 100 mm) at Weeks 4, 8, 12, 16, 20 and 24
    -Patient’s global assessment of disease activity (VAS 100 mm) at Weeks 4, 8, 12, 16, 20 and 24
    -Physician’s global assessment of disease activity (VAS 100 mm) at Weeks 4, 8, 12, 16, 20 and 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above, timepoints added to each single end point
    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 Yes
    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
    At Week 16, patients will receive rabeximod 15 mg during an extension of 8 Weeks
    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 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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    United States
    Poland
    Bulgaria
    Bosnia and Herzegovina
    Georgia
    Hungary
    Moldova, Republic of
    Serbia
    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
    LPLV
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 91
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 160
    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)
    Standard of care
    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 Decision2022-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-27
    P. End of Trial
    P.End of Trial StatusOngoing
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