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    Summary
    EudraCT Number:2020-004047-86
    Sponsor's Protocol Code Number:AIS-A03
    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:2021-12-23
    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 number2020-004047-86
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus
    Az ALPN-101 randomizált, kettős-vak, placebo kontrollos vizsgálata
    szisztémás lupus erythematosus esetén
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of ALPN-101 in Active Lupus
    Az ALPN-101 vizsgálata aktív lupus esetén
    A.4.1Sponsor's protocol code numberAIS-A03
    A.5.4Other Identifiers
    Name:IND NumberNumber:146045
    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 SponsorAlpine Immune Sciences, 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 supportAlpine Immune Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationParexel International
    B.5.2Functional name of contact pointHansi Kumari
    B.5.3 Address:
    B.5.3.1Street Address70 Sir John Rogerson's Quay
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.4Telephone number+1954 232 9569
    B.5.6E-mailHansi.Kumari@parexel.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 ALPN-101
    D.3.4Pharmaceutical form Solution for infusion
    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 INNAcazicolcept
    D.3.9.1CAS number 2270247-50-0
    D.3.9.2Current sponsor codeALPN-101
    D.3.9.3Other descriptive nameALPN-101
    D.3.9.4EV Substance CodeSUB221298
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboSolution for infusion
    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
    Systemic lupus erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10042946
    E.1.2Term Systemic lupus erythematosus rash
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042948
    E.1.2Term Systemic lupus erythematosus syndrome aggravated
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042947
    E.1.2Term Systemic lupus erythematosus synd
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029142
    E.1.2Term Nephritis systemic lupus erythematosus
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067657
    E.1.2Term Systemic lupus erythematosus disease activity index increased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067658
    E.1.2Term Systemic lupus erythematosus disease activity index decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067659
    E.1.2Term Systemic lupus erythematosus disease activity index abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10080670
    E.1.2Term Systemic lupus erythematosus reactivation
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073694
    E.1.2Term Lupus pleurisy
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10040968
    E.1.2Term SLE 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 evaluate the safety and tolerability of ALPN-101 compared to placebo in subjects with moderate to severe active SLE
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ALPN-101 in subjects with active SLE
    • To assess the pharmacokinetics (PK) of ALPN-101 in active SLE
    • To assess the incidence of anti-drug antibodies (ADA) against ALPN-101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Written informed consent
    •Age 18 to 65
    •Diagnosis of lupus for ≥ 6 months prior to Screening
    •Positive anti-nuclear antibodies (ANA) and/or elevated anti-double-stranded DNA (dsDNA) and/or elevated anti-Smith antibody test at Screening
    •Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor
    •Standard lupus medications must be stable prior to Screening
    •Women must have a PAP smear and known HPV status within 12 months of Day 1
    •All participants must use highly effective birth control if they/their partner are capable of becoming pregnant
    E.4Principal exclusion criteria
    •Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study
    •Proteinuria consistent with nephrotic syndrome
    •Active lupus-related neuropsychiatric disease
    •Drug-induced lupus
    •Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes
    •Recent or serious ongoing infection; risk or history of serious infection
    •Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study
    •Unacceptable Screening laboratory results
    •History of new, ongoing, or recurrent malignancy ≤ 5 years prior to Day 1, with some exceptions per-protocol
    •Pregnant or breastfeeding at the time of screening, or plans to become pregnant ≤ 3 months following the last dose of study drug
    •Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
    •Diagnosis of, or fulfills diagnostic criteria for, fibromyalgia
    •Functional class IV lupus
    •Does not meet protocol washout periods for concomitant medications
    •Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk
    •Ongoing participation in another therapeutic clinical trial
    •Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be assessed by evaluating the type, frequency, severity, and seriousness of adverse events, including clinically significant changes in symptoms, physical exam findings, vital signs, laboratory tests (hematology, serum chemistries and coagulation, urinalysis), and electrocardiograms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    According to protocol
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    Efficacy endpoints will be assessed by evaluating disease activity relative to baseline and across treatment groups using the tools and assessments listed below, and derivatives calculated from them (e.g. SLE Responder Index [SRI] -4, -5, -6 response; time to and proportion with flare of SLE; others).
    -Global Disease Activity Assessment Tools:
    • British Isles Lupus Assessment Group index (BILAG) 2004
    • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); SLEDAI-2K 30-Day (SLEDAI-2K 30)
    • Physician’s Global Assessment of SLE Disease Activity (PhGA)
    -Organ-Specific Disease Activity Assessment Tools:
    • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), with photography when appropriate
    • Swollen Joint Count-28 (SJC-28)
    • Tender Joint Count-28 (TJC-28)
    • Estimated glomerular filtration rate (eGFR)
    • Proteinuria assessed as urine protein to creatinine ratio (UPCR),
    • Urinary sediment analysis for hematuria, pyuria, and red cell casts
    -Patient Reported Outcomes and Quality of Life Assessment tools:
    • Patient’s Global Assessment of Disease Activity (PtGA)
    • Short Form-36 (SF-36) health survey
    • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (13-Item)
    -Clinical Biomarkers of SLE Activity:
    • High-sensitivity C-reactive protein (hsCRP)
    • Complement levels: C3, C4, CH50
    • Anti-dsDNA antibodies
    -Corticosteroids:
    • Dose of oral and parenteral corticosteroids

    Pharmacokinetic Endpoints:
    Serum concentrations of ALPN-101 will be measured. Pharmacokinetic endpoints include estimates of maximum concentration (Cmax), area under the concentration-time curve (AUC), and trough concentration (Ctrough) at the end of dosing intervals.

    Immunogenicity Endpoints:
    The presence and titer of ADA against ALPN-101 will be assessed at Baseline (prior to study drug administration on Day 1) and at intervals throughout the study. Samples confirmed positive for ADA may be explored for neutralizing capacity. The relationship between ADA and PK will be analyzed; relationship between ADA and clinical outcomes may be explored.

    Pharmacodynamic Endpoints:
    Blood and urine will be collected at intervals; target saturation by ALPN-101 on circulating lymphocytes will be assessed; plasma, sera and peripheral blood mononuclear cells (PBMCs) will be prepared and may be assessed for biomarkers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    According 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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 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 EEA27
    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
    Germany
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United States
    France
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 130
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 130
    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 Decision2022-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
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