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    Summary
    EudraCT Number:2020-004047-86
    Sponsor's Protocol Code Number:AIS-A03
    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:2021-06-09
    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 number2020-004047-86
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS
    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
    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
    •Males and females, age 18 through 70 years, inclusive, at Screening
    •Diagnosis of lupus for ≥ 6 months prior to Screening
    •Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening
    •Active SLE as defined at Screening as confirmed by Sponsor or
    designee, and at Baseline (i.e., prior to randomization on Day 1) as
    confirmed by Investigator
    • Stable, appropriate standard of care for SLE

    List of extended Inclusion Criteria changes only below. Please see
    protocol for full list:

    1. Males and females, age 18 through 70 years, inclusive, at Screening.

    3. Subjects must have a positive anti-nuclear antibodies (ANA) (titer ≥
    1:80) and/or elevated anti-dsDNA and/or elevated anti-Smith antibody
    test (if the screening test(s) are negative [based on central or local
    testing], then an historic positive serology for ANA, elevated anti-dsDNA,
    and/or elevated anti-Smith antibody test, with unequivocal
    documentation, may be accepted).

    7. Subjects must be on appropriate SOC (i.e., at least one anti-malarial
    or an immunosuppressant) for SLE, based on the Investigator's
    judgement. If taking the following medications, the subject must be on a
    stable dose prior to Baseline (i.e., Day 1 prior to randomization) for the
    period of time specified below, and must intend to continue at stable
    doses throughout the 24-week
    Treatment Period, unless otherwise specified by this protocol:

    8. Willing to provide consent for serial photographic documentation of
    any cutaneous manifestations of SLE, and/or oral mucocutaneous
    lesions (including aphthous ulcers) not attributed to SLE, from Screening
    through the EoS.

    11. Should be up-to-date on all age-appropriate vaccinations, including
    COVID-19, per local and professional guidelines for
    immunocompromised individuals (e.g., CDC, local professional society
    guidelines).

    12. Peripheral venous access anticipated to be adequate to tolerate
    planned dosing regimen of IV infusions and blood draws Q2W per Table 1
    E.4Principal exclusion criteria
    • Life-threatening or organ system-threatening SLE activity, that is
    sufficiently active that it is expected to require increase in treatment
    during the study
    • Proteinuria consistent with nephrotic syndrome: ≥ 3.5 g
    proteinuria/day, estimated based on urine protein-creatinine ratio
    (UPCR) ≥ 350 mg/mmol at Screening
    • Active lupus-related neuropsychiatric disease (with the exceptions of
    mild stable lupus headache, fatigue, mild stable organic brain syndrome)
    • Drug-induced lupus
    • Evidence of active infection or risk or history of serious infection with
    tuberculosis; hepatitis B, hepatitis C; HIV
    • Evidence of active infection with SARS-CoV-2

    List of extended Inclusion Criteria changes only below. Please see
    protocol for full list:

    5. h. Current or recent (within the past 12 months) history of alcoholism
    or significant drug abuse (recreational use of cannabis is not an
    exclusion criterion).

    6. a. Active or latent TB (refer to §6.7 for specific requirements for TB
    screening). Subjects with a history of latent TB are allowed with
    documentation of completed treatment with a regimen recommended by
    an appropriate local or national health authority (e.g., CDC).
    b. Hepatitis B virus: serologic evidence of hepatitis B infection based on
    the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B
    core antibody (HBcAb), and hepatitis B
    surface antibody (HBsAb) as follows:
    i. Subjects positive for HBsAg are excluded.
    ii. Subjects negative for HBsAg but positive for HBcAb, regardless of
    HBsAb status will be excluded.
    c. Hepatitis C virus (HCV): HCV RNA detectable in any subject with
    positive HCV antibody.
    d. Seropositivity for HIV at Screening.
    e. Positive reverse transcription polymerase chain reaction (RT-PCR) test
    for SARS-CoV-2 at Screening.
    f. History of progressive multifocal leukoencephalopathy.
    g. Receipt of oral or parenteral anti-infectives (antibacterials, antivirals,
    antifungals, or antiparasitic agents) for infection, ≤ 2 weeks prior to Day
    1 (NOTE: chronic oral antibiotics
    used for prophylaxis may be permitted, dependent on discussion with,
    and agreement of, the Medical Monitor).

    14. Functional class IV as defined by the ACR 1991 Revised Criteria for the Classification of Global Functional Status in Rheumatoid Arthritis.

    15.
    e. Biologic therapies, including but not limited to: atacicept, telitacicept,
    belimumab, abatacept, belatacept, anifrolumab, inhibitors of interleukin
    (IL) pathways IL-6, IL-12/23, IL-17, IL-1, tumor necrosis factor α, or
    interferon α: 12 weeks (exception: the use of prophylactic COVID-19
    monoclonal antibodies in immunocompromised subjects is encouraged
    as per Principal Investigator's discretion and local guidelines).
    j. Combination therapy with ≥ 2 immunosuppressants for the treatment
    of SLE: A discussion with, and agreement by, the Medical Monitor and
    Sponsor will be required.

    18. Known hypersensitivity to ALPN-101, components thereof, or
    excipients contained in the drug formulation.

    19. Any condition or circumstances which in the opinion of the
    Investigator or Sponsor may make a subject unlikely or unable to
    complete the study or comply with study procedures and
    requirements.
    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 concerned8
    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
    United States
    Russian Federation
    France
    Germany
    Hungary
    Poland
    Spain
    Korea, Republic of
    Taiwan
    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 years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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 state11
    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 Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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