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    Summary
    EudraCT Number:2019-003406-27
    Sponsor's Protocol Code Number:SL0043
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-23
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-003406-27
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
    Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná
    studie s paralelními skupinami hodnotící účinnost a bezpečnost přípravku
    dapirolizumab pegol u účastníků studie se středně závažnou až závažnou
    formou aktivního systémového lupus erythematodes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus
    Randomizovaná, placebem kontrolovaná studie hodnotící účinnost a
    bezpečnost přípravku dapirolizumab pegol u účastníků studie se středně
    závažnou až závažnou formou aktivního systémového lupus erythematodes
    A.3.2Name or abbreviated title of the trial where available
    PHOENYCS GO
    A.4.1Sponsor's protocol code numberSL0043
    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 SponsorUCB Biopharma SRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.6E-mailclinicaltrials@ucb.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 nameDapirolizumab pegol
    D.3.2Product code CDP7657
    D.3.4Pharmaceutical form Powder for 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 INNDapirolizumab pegol
    D.3.9.2Current sponsor codeDZP
    D.3.9.3Other descriptive nameCDP7657
    D.3.9.4EV Substance CodeSUB30739
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 erythematosus is a chronic autoimmune inflammatory disease which can present with a persistent active disease course but has more often a relapsing-remitting disease course.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity
    E.2.2Secondary objectives of the trial
    Evaluate the ability of DZP as an add-on treatment to SOC medication:
    - to achieve fast, clinically relevant improvement of moderate to severe disease activity
    - to achieve long term control of disease activity
    - to achieve and maintain the treat-to-target goal: low disease activity with low/acceptable corticosteroid dose over time
    - to achieve improvement of disease activity as measured by numerical disease state score commonly used in clinical practice
    - to achieve components of the composite primary endpoints
    - to achieve alternative responder endpoint
    - to achieve endpoints supporting other key secondary endpoints
    To evaluate the safety and tolerability of DZP as add-on treatment to SOC medication
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
    -Study participant must be ≥16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
    - Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC)medication defined as:
    a. Diagnosed with SLE at least 24 weeks before Screening Visit (Visit 1) by a qualified physician
    b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)classification criteria for SLE
    c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following:
    i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory at Screening)
    ii) Either complement C3 < lower limit of normal (LLN) OR complement C4 <LLN OR elevated erythrocyte-bound complement C4d (where available) as measured by central laboratory
    iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
    1. Anti-Smith (anti-Sm) antibodies (central laboratory)
    2. Anti-Sjögren’s syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren’s syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
    3. Historic evidence for anti-dsDNA antibodies
    d. Moderately to severely active defined as
    -British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit
    AND
    -Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at Screening Visit
    AND
    -SLEDAI-2K without labs ≥4 at Baseline Visit
    e. Receiving the following SOC medication at stable dose:
    ◦ Anti-malarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified
    OR
    ◦ Treatment with corticosteroids and/or immunosuppressants if anti-malarial treatment is not possible
    E.4Principal exclusion criteria
    - Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
    This includes study participants with a life threatening condition
    - Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
    - Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma
    - Study participants has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
    - Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection
    - Study participant had a reactivated latent infection (example, cytomegalovirus, herpes simplex
    virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2), or is currently receiving suppressive therapy for an
    opportunistic infection
    - Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
    - Study participant has clinically significant active or latent infection
    - Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
    - Study participant takes any protocol defined prohibited concomitant medication
    - Study participant has previously been randomized within this study or participant has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP
    - Study participant has participated in another study of an IMP within the previous 12 weeks or 5 half-lives of the investigational medicinal product (IMP) whatever is longer or is currently participating in another study of an IMP
    - Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate <30 mL/min/1.73 m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit
    E.5 End points
    E.5.1Primary end point(s)
    Achievement of BICLA response at Week 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    E.5.2Secondary end point(s)
    1. Achievement of BICLA response at Week 24
    2. Achievement of BICLA response at Week 12
    3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
    4. Achievement of LLDAS in ≥50% of post-Baseline visits through Week 48
    5. Change from Baseline in SLEDAI-2K at Week 48
    6. Achievement of BILAG improvement without worsening at Week 48
    7. Change from Baseline in PGA at Week 48
    8. Achievement of SRI4 response at Week 48
    9. Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flare-free) through Week 48
    10. Time to severe BILAG Flare through Week 48
    11. Time to moderate/severe BILAG flare through Week 48
    12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
    13. Percentage of participants with serious treatment-emergent adverse events during the study
    14. Percentage of participants with treatment-emergent adverse events of special interest during the study
    15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Week 24
    2: Week 12
    3, 4: During Treatment Period up to Week 48
    5, 7: From Baseline (Day 1) to Week 48
    6, 8: Week 48
    9, 10, 11: During Treatment Period up to Week 48
    12, 13, 14, 15: From Baseline (Day 1) until Safety Follow-Up (up to Week 54)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Argentina
    Chile
    Colombia
    Peru
    Philippines
    Taiwan
    Australia
    Canada
    Korea, Republic of
    Mexico
    Serbia
    United Kingdom
    United States
    Austria
    Belgium
    Bulgaria
    Czechia
    Denmark
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Romania
    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 years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 296
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 312
    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)
    Study participants who complete the 48-week Treatment Period may be eligible to participate in an open label extension (OLE) study. Study participants who withdraw early from the 48-week Treatment Period or choose not to enter the OLE will be followed up for at least 10 weeks Safety Follow-up (SFU) after their final dose of study medication.
    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 Decision2021-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-06-04
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