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    Summary
    EudraCT Number:2021-005771-39
    Sponsor's Protocol Code Number:RVLO221-02
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-20
    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 number2021-005771-39
    A.3Full title of the trial
    A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate IRL201805 in patients with rheumatoid arthritis
    A.3.2Name or abbreviated title of the trial where available
    RVLO 221-02 IRL201805 in rheumatoid arthritis
    A.4.1Sponsor's protocol code numberRVLO221-02
    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 SponsorRevolo Biotherapeutics Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportRevolo Biotherapeutics Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRevolo Biotherapeutics Ltd
    B.5.2Functional name of contact pointBeth Alley
    B.5.3 Address:
    B.5.3.1Street Addressc/o BCS Limited Windsor House, Station Court, Station Road
    B.5.3.2Town/ cityGreat Shelford, Cambridge
    B.5.3.3Post codeCB22 5NE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0012243554532
    B.5.6E-mailballey@revolobio.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 nameIRL201805
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRL201805
    D.3.9.2Current sponsor codeIRL201805
    D.3.9.3Other descriptive nameModified BiP
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Joint pain and swelling
    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 increasing doses of IRL201805 on the treatment of rheumatoid arthritis (RA) as measured by change from baseline in the disease activity score at Week 12 compared with placebo treatment in patients.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of IRL201805 compared to placebo based on the Clinical Disease Activity Index (CDAI)

    To evaluate the efficacy of IRL201805 compared to placebo on other markers of RA disease activity over time

    To evaluate the effects of IRL201805 compared to placebo on blood markers of RA

    To evaluate the generation of potential anti-drug antibodies (ADAs)

    To evaluate the efficacy of IRL201805 compared to placebo on protocol-defined patient reported outcome (PRO) and clinician reported outcome (CRO) questionnaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A participant must meet the following criteria to be eligible for inclusion in the study:
    Demographic and Laboratory Assessments:
    1. Participants are men or women ages ≥ 18 and ≤ 75 years.
    2. Participant must have laboratory values meeting the criteria listed below within the screening period prior to the first dose of study drug. Outofrange laboratory parameters may be rechecked one time, after consultation with the sponsor or its designee, before the participant is considered a screen failure.
    a. Serum alanine transaminase (ALT) < 2 × upper limit of normal (ULN)
    b. Total white blood cell (WBC) count > 3000/μL
    c. Absolute neutrophil count (ANC) > 1500/μL
    d. Platelet count > 100,000/μL
    e. Absolute lymphocyte count > 800/μL
    f. Hemoglobin > 10 g/dL
    3. Participant must have a negative test result for hepatitis A virus immunoglobulin M (HAVIgM), hepatitis B surface antigen (HBsAg), HBcAb (participants who have been vaccinated against hepatitis B [HB] and are HBsAb positive may be enrolled), hepatitis C virus (HCV) antibody (if hepatitis C RNA level is undetectable at Screening, the participant can participate in this study), and human immunodeficiency virus (HIV) Ab at Screening.
    4. Participant must have a negative tuberculosis (TB) test: QuantiFERON TB-Gold In-Tube test (or equivalent if compliant with local TB guidelines) or purified protein derivative (PPD). Participants who have previously received an adequate course of therapy as per local standard of care for latent TB do not require TB test.
    5. Participant is able and willing to provide written informed consent and comply with the requirements of the study protocol.
    Diagnosis and Disease Activity:
    6. Participant has a clinical diagnosis of RA for > 3 months based on the 1987 ACR classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
    7. Participant has moderately to severely active RA defined as: ≥ 6 swollen joints (from a SJC66) and ≥ 6 tender joints (from a TJC68) at both Screening and Baseline/Day 1.
    8. Participant has a high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
    9. Participant has an incomplete response to MTX. Participants must have been on oral or parenteral MTX therapy ≥ 3 months and on a stable prescription of 15 to 25 mg/week (or ≥ 10 mg/week in participants intolerant of methotrexate at doses ≥ 15 mg/week) for ≥ 4 weeks prior to the first dose of study drug. Participant must be expected to be able to continue on a stable dose of MTX for the duration of study participation. Dose adjustments are only permitted for the management of toxicity.
    10. Prior treatment with additional conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed; however, the participant must be on MTX only at Baseline/Day 1 and an appropriate washout needs to be satisfied, as specified in the protocol (Section 9.2) to be eligible for the study.
    11. Participants must have discontinued all biologic DMARD (bDMARD) and targeted synthetic DMARD (tsDMARD) therapy prior to the first dose of study drug. The washout period of these agents prior to the first dose of study drug is specified below or should at least 5 times the mean terminal elimination half-life of a drug:
    a. ≥ 4 weeks for etanercept, adalimumab, infliximab, certolizumab, golimumab, tocilizumab, and abatacept
    b. prior rituximab treatment is not allowed
    c. ≥ 4 weeks for any tsDMARD (including but not limited to upadacitinib, tofacitinib, baricitinib, and fligotinib)
    Contraception
    12. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control from Screening and must agree to use 1 of these methods through at least 70 days after the last dose of study drug or Week 24, whichever is longer. Female participants of non-childbearing potential do not need to use birth control (see Appendix 1 of the protocol).
    E.4Principal exclusion criteria
    A participant who meets any of the following criteria will be ineligible to participate in this study:
    Participant History
    1. Participant has a history of persistent chronic or active infection(s) requiring hospitalization or treatment with parenteral anti-infectives within 30 days, or oral anti-infectives within 14 days prior to the first dose of study drug administration.
    2. Participant has a history or evidence of active TB.
    3. Participant has a history of malignancy within 5 years prior to Screening, except completely treated in situ carcinoma of the cervix and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
    4. Participant has a history of clinically significant medical conditions or any other reason (eg, clinically significant drug or alcohol abuse) that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
    5. Participant has known hypersensitivity to IRL201805 or its excipients (ie, penicillin or aminoglycosides).
    6. Participant is currently enrolled in another clinical study and/or has previously been enrolled in the current study.
    Diagnosis and Disease Activity:
    7. Participant has a history of being exposed to > 1 biologic (bDMARD) or targeted synthetic (tsDMARD) therapy for RA. Participants with exposure to 1 bDMARD and 1 tsDMARD are not eligible.
    Concomitant Medications:
    8. Participant is taking systemic glucocorticoids (GCs) > 7.5 mg/day prednisone equivalent. Stable dose of GC (≤ 7.5 mg/day prednisone equivalent) started at least 4 weeks prior to the Baseline/Day 1 visit is permitted.
    9. Participant has been treated with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.
    10. Participant has been treated with intra-articular, intramuscular, IV, trigger point or tender point, intrabursa, or intratendon sheet corticosteroids in the preceding 4 weeks prior to the first dose of the study drug.
    11. Participant has received a live vaccine within 4 weeks prior to the first dose of study drug or expects to need a live vaccination during study participation.
    Contraception:
    12. Participant is a female who has a positive pregnancy test at Screening or Baseline/Day 1.
    13. Participant is a female who is breastfeeding or considering becoming pregnant during the study.

    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:

    • Change from baseline in DAS28-CRP at Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Baseline/Day 1, Week 4, Week 8, Week 12, Week 18, Week 24/EoTl.
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Change from baseline in CDAI and SDAI over time through Week 24
    • Proportion of participants achieving implied clinical remission (CR) at Week 12. CR is defined as DAS28-CRP < 2.6
    • Proportion of participants achieving implied low disease activity (LDA) at Week 12. LDA is defined as DAS28-CRP ≤ 3.2
    • Proportion of participants achieving LDA or CR based on CDAI criteria over time through Week 24
    • ACR20/50/70 response rates determined based on 20%/50%/70% or greater improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and ≥ 3 of the 5 measures of Patient's Assessment of Pain (Visual Analog Scale [VAS]), Patient's Global Assessment of Disease Activity (PtGA), Physician’s Global Assessment of Disease Activity (PhGA), Health Assessment Questionnaire Disability Index (HAQDI), and acute phase reactant (hsCRP or erythrocyte sedimentation rate [ESR]) as assessed over time through Week 24
    • Change from baseline in individual components of ACR response over time through Week 24
    • Change from baseline in DAS28-CRP and DAS28–ESR over time through Week 24
    • Measurement of the following serologic markers: circulating levels of immunoglobulin (IG), titre anti-citrullinated protein/peptide antibody (ACPA), hsCRP, and ESR, rheumatoid factor over time through Week 24
    • Measurement of plasma concentrations of IRL201805
    • Measurement of any ADA response
    • Change from baseline for the following outcome (ie, PRO or CRO) instruments: Health Assessment Questionnaire – Disability Index (HAQDI); pain VAS; 36Item ShortForm Survey (SF-36). The use of Global Assessments: Patient Global Assessment, Physician Global Assessment, and fatigue (Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F]) over time through Week 24

    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol.
    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 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 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 trial4
    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 EEA19
    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
    Georgia
    United Kingdom
    Bulgaria
    Czechia
    Germany
    Hungary
    Latvia
    Poland
    Spain
    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 years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 92
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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