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    Summary
    EudraCT Number:2022-000609-28
    Sponsor's Protocol Code Number:ESR-21-21284
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-000609-28
    A.3Full title of the trial
    ANIfrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome – Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of anifrolumab treatment for 24 weeks in patients with primary Sjögren’s syndrome compared to placebo
    A.3.2Name or abbreviated title of the trial where available
    ANISE-II
    A.4.1Sponsor's protocol code numberESR-21-21284
    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 SponsorUniversity Medical Centre Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca BV
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Groningen
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503613432
    B.5.5Fax number+31503619308
    B.5.6E-mailh.bootsma@umcg.nl
    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 Yes
    D.2.1.1.1Trade name Saphnelo
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAnifrolumab
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboInfusion
    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
    Primary Sjögren's syndrome. Patients will be included if the fulfil the 2016 ACR/EULAR classification criteria for pSS and if they have active disease according to an ESSDAI score of 5 or more and/or an ESSPRI score of 5 or more.
    E.1.1.1Medical condition in easily understood language
    Primary Sjögren's syndrome, a systemic, auto-immune disease.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the clinical efficacy of anifrolumab in patients with primary Sjögren’s syndrome
    E.2.2Secondary objectives of the trial
    To determine the safety of anifrolumab and effects of anifrolumab on clinical, functional, subjective, laboratory and histopathological parameters in patients with primary Sjögren's syndrome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent.
    - Female or male aged >= 18 years.
    - Disease duration <= 10 years.
    - Fulfillment of the 2016 ACR/EULAR classification criteria.
    - ESSDAI >=5 and/or ESSPRI >=5. ESSDAI >=5 implicates a moderate to high systemic disease activity and ESSPRI >=5 implicates that the patient-reported symptom state is unacceptable. At least 50% of patients need to fulfil the ESSDAI >=5 criterion. Inclusion of patients with low ESSDAI (<5) should be discontinued when 50% have a low ESSDAI.
    - For biopsy-positive pSS patients: willingness to undergo a repeated biopsy. Baseline biopsy ≤1 year before inclusion and follow-up biopsy 24 weeks after start treatment.
    - Use of reliable method of contraception for participants of reproductive potential.
    - Fully vaccinated against SARS-CoV-2, based on the current vaccine recommendations for immunocompromised patients.
    - Weight of >= 40 kg.
    E.4Principal exclusion criteria
    - Presence of any other connective tissue disease.
    - Positive pregnancy test at screening or breastfeeding.
    - History of alcohol or drug abuse.
    - History of malignancy or with a current suspicion for cancer, apart from local MALT lymphoma, squamous or basal cell carcinoma of the skin treated with documented success of curative therapy >=3 months prior to week 0 or cervical cancer in situ treated with apparent success with curative therapy >=1 years prior to week 0.
    - Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of HIV which will be tested during screening.
    - History of chronic or recurrent serious infections.
    - Subjects who have received any live or attenuated vaccines within 8 weeks prior to signing the ICF.
    - Blood transfusion or receipt of blood products within 4 weeks prior to signing the ICF.
    - Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, hematological or neurological conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in this study.
    - Preceding treatment with biological DMARDs, including abatacept, anti-TNF or other monoclonal antibodies within 6 months, and rituximab within 12 months from baseline.
    - Use of high-dose prednisone, less than 2 weeks before inclusion. Stable low dose (<= 10 mg) is allowed.
    - Use of hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine, azathioprine, MMF and leflunomide less than 3 months ago.
    E.5 End points
    E.5.1Primary end point(s)
    Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) response at week 24. The CRESS is a recently developed composite endpoint which consists of five clinically relevant items for pSS: a systemic disease activity, patient-reported symptoms, tear gland, salivary gland and serology item. A CRESS responder is someone who reached response on at least three out of five items.
    CRESS response at week 24 was selected as primary outcome measure since the CRESS is a comprehensive and clinically relevant composite endpoint which encompasses all of the major disease features of pSS. In our development and validation study, CRESS was able to lower placebo response in several randomised controlled trials (RCTs), compared to the ESSDAI score alone. Furthermore, the CRESS was able to demonstrate beneficial treatment effects of abatacept and rituximab in RCTs which did not meet their primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at week 24.
    E.5.2Secondary end point(s)
    - Safety (adverse events and tolerability) of anifrolumab by monitoring SAE and AE, treatment discontinuation related to SAE and AE, and lab abnormalities at weeks 0, 4, 8, 12, 16, 20 and 24
    - Total CRESS response at week 12
    - Individual CRESS items (continuous): ClinESSDAI (weeks 0, 8, 12, 20, 24), ESSPRI (weeks 0, 8, 12, 20, 24), Schirmer’s test (weeks 0, 12, 24), OSS (weeks 0, 12, 24), UWS (weeks 0, 12, 24), SGUS (Hocevar score) (weeks 0, 12, 24), RF and total IgG concentration in blood (weeks 0, 8, 12, 20, 24).
    - ESSDAI (continuous) (weeks 0, 4, 8, 12, 20, 24)
    - The (Clin)ESSDAI minimal clinically important improvement (MCII, defined as decrease of ≥3 points) and low disease activity (LDA, defined as score <5) (weeks 8, 12, 20, 24)
    - Physician GDA (weeks 0, 8, 12, 20, 24)
    - NRS score oral, ocular, and vaginal dryness and mental fatigue (weeks 0, 8, 12, 20, 24)
    - Patient GDA (weeks 0, 8, 12, 20, 24)
    - SF-36 health survey (weeks 0, 12, 24)
    - EQ-5D measure of health-related quality of life (weeks 0, 8, 12, 20, 24)
    - MFI scale (weeks 0, 12, 24)
    - FSFI in females (weeks 0, 12, 24)
    - SWS (weeks 0, 12, 24)
    - Parotid gland histology at baseline vs. week 24: focus score and area fraction of CD45+ infiltrate
    - Serum levels of anti-SSA/-SSB, complement (C3/C4), lymphocyte count, and presence of cryoglobulinemia (weeks 0, 8, 12, 20, 24)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments will be conducted at week 0, 4, 8, 12, 16, 20 and 24. Some of the outcome measures will be evaluated at all time points, and some of the outcome measures only at the most important timepoints (week 12 and 24).
    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 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 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 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 (week 24).
    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
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state30
    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)
    A follow-up visit will be planned 3 months after the last visit (week 24) for all participants.
    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 Decision2022-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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