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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001377-31
    Sponsor's Protocol Code Number:HZNP-DAX-203
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-10-25
    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 ConcernedCroatia - MIZ
    A.2EudraCT number2022-001377-31
    A.3Full title of the trial
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    A.4.1Sponsor's protocol code numberHZNP-DAX-203
    A.5.4Other Identifiers
    Name:Investigational New Drug (IND)Number:127898
    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 SponsorHorizon Therapeutics Ireland DAC
    B.1.3.4CountryIreland
    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 supportHorizon Therapeutics Ireland DAC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHorizon Therapeutics Ireland DAC
    B.5.2Functional name of contact pointAdina Kay Knight, MD, Sr. Med. Dir.
    B.5.3 Address:
    B.5.3.1Street Address2400 Research Blvd
    B.5.3.2Town/ cityRockville, MD
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12409726144
    B.5.6E-mailaknight2@horizontherapeutics.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 nameDAXDILIMAB
    D.3.2Product code HZN-7734, MEDI7734, VIB7734
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDaxdilimab
    D.3.9.1CAS number 2245966-28-1
    D.3.9.2Current sponsor codeHZN-7734
    D.3.9.3Other descriptive nameVIB7734, MEDI7734
    D.3.9.4EV Substance CodeSUB195573
    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 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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    E.1.1.1Medical condition in easily understood language
    ACTIVE PROLIFERATIVE LUPUS NEPHRITIS
    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 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 efficacy of daxdilimab in combination with SOC compared to placebo in combination with SOC in participants
    with active, proliferative LN.
    E.2.2Secondary objectives of the trial
    To assess overall renal response (ORR) (defined as CRR plus partial renal response [PRR]) with daxdilimab versus placebo in participants with active, proliferative LN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.
    2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
    3. Adult men or women ≥ 18 and ≤ 80 years of age.
    4. Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for systemic lupus erythematosus (SLE) (Aringer et al, 2019).
    5. Have at least one of the following at Screening per central lab:
    - Antinuclear antibodies (ANA) ≥ 1:80.
    - Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range as established by the central laboratory (ie, positive results).
    - Anti-Smith antibodies elevated to above normal (ie, positive results).
    6. Diagnosis of proliferative LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form (ICF) or during the Screening Period:
    - Class III (± class V) or class IV (± class V) LN according to the World Health Organization (WHO) or 2003 ISN/RPS classification (based on local evaluation of renal biopsy).
    Note: the local biopsy report will be used to confirm participant eligibility. The submission of the Screening biopsy sample (archived or fresh tissue block, slides or digital pathology images) for adjudication is required to participate in the study.
    7. Urine protein to creatinine ratio ≥1.5 mg/mg (113.17 mg/mmol), obtained via a 24-hour urine collection at both:
    - The start of Screening and
    - Within 14 days of expected date of Randomization. Without the results of the second sample, which will be used for stratification, participants cannot be randomized. The second sample may be collected after a minimum of 10 days after the Screening sample was obtained. The second sample may be repeated once, upon approval by the Medical Monitor (this will not be considered a re-screen). Typical turn-around time for results from central laboratory is up to 7 days. On rare occasion, an extension of the 28-day screening window is allowed if re-collection of the sample is necessary or the results needed for Randomization are delayed.
    8. Estimated glomerular filtration rate (as calculated by the Modification of Diet in Renal Disease [MDRD] formula, with screening laboratory results for serum creatinine value) ≥ 35 mL/min/1.73 m2.
    9. Negative serum β human chorionic gonadotropin (β-hCG) test at Screening (females of childbearing potential only).
    E.4Principal exclusion criteria
    1. Individuals involved in the conduct of the study, their employees, or immediate family members of such individuals.
    2. Any condition that, in the opinion of the Investigator or the Sponsor/Central Review Committee, would interfere with evaluation of the IP or interpretation of participant safety or study results.
    3. Weight > 160 kg (352 pounds) at Screening.
    4. History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or to a previous monoclonal antibody (mAb) or human immunoglobulin (Ig) therapy.
    5. Known intolerance to ≤1.0 gm/day of MMF or equivalent dose of MPA.
    6. Participation in another clinical study with an investigational drug within 4 weeks prior to Day 1 or within 5 published half-lives, whichever is longer.
    7. Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP.
    8. History of drug or alcohol abuse that, in the opinion of the Investigator, might affect participant safety or compliance with visits, or interfere with other study assessments.
    9. Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through the end of the trial.
    10. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to Screening through Randomization.
    11. A diagnosis of pure Class V membranous LN based on a renal biopsy obtained within 6 months prior to signing ICF or during the Screening Period.
    12. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 12-month period after enrollment.
    13. History of, or current renal diseases (other than LN) that in the opinion of the Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
    14. Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
    15. During Screening, any of the following per central laboratory (tests may be repeated once within the same Screening Period to confirm results prior to Randomization):
    - Aspartate aminotransferase > 2.5× upper limit of normal (ULN)
    - Alanine aminotransferase > 2.5× ULN
    - Total bilirubin > 1.5× ULN (unless due to Gilbert’s syndrome)
    - Serum IgG < 600 mg/dL (or < 6 g/L) or < 400 mg/dL (<4 g/L) if due to active SLE/LN
    - Neutrophil count < 1000/μL (or < 1.0×10 9/L) or < 500/μL (< 0.5×10 9/L) if due to active SLE
    - Platelet count < 50,000/μL (or < 50×10 9/L) or < 25,000/μL (< 25×10 9/L) if due to active SLE
    - Hemoglobin < 8 g/dL (or < 80 g/L) or < 7 g/dL (< 70 g/L) if due to active SLE
    - Glycosylated hemoglobin > 8% (or > 0.08)
    -Total lymphocyte count < 200 cells/mm3
    16. Confirmed positive test for hepatitis B serology defined as:
    - Hepatitis B surface antigen, or
    - Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA detected above the lower limit of quantitation (LLOQ) by reflex testing by the central laboratory at Screening.
    17. Positive test for hepatitis C virus antibody unless documented as having had successful treatment of active hepatitis C infection.
    18. Active tuberculosis (TB), or a positive IFN-gamma release assay (IGRA) test at Screening, unless documented history of appropriate treatment for active or latent TB. Note that participants with an indeterminate IGRA test result with well-documented previous treatment do not need to repeat testing and are eligible for randomization. Participants with an indeterminate IGRA test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
    19. Any severe herpes virus family infection (including Epstein-Barr virus, cytomegalovirus [CMV]) at any time prior to Randomization, including, but not limited to, disseminated herpes, herpes encephalitis, recent recurrent herpes zoster (defined as 2 episodes within the last 2 years), or ophthalmic herpes.
    20. Any herpes zoster, CMV, or Epstein-Barr virus infection that was not completely resolved 12 weeks prior to Randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving Complete Renal Response (CRR)
    CRR is defined as meeting all of the following:
    - Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 or no worse than 15% below baseline
    - 24-hour UPCR ≤ 0.5 mg/mg
    - No discontinuation of study intervention or use of restricted medication beyond protocol allowed threshold before assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48 and sustained through Week 52.
    E.5.2Secondary end point(s)
    Proportion of participants achieving ORR (defined as CRR plus PRR)
    See above for definition of CRR. PRR is defined as meeting all of the following:
    - eGFR ≥ 60 mL/min/1.73m2 or no worse than 15% below baseline
    - Improvement in 24-hour UPCR:
    - For participants with a baseline UPCR ≤ 3.0 mg/mg:
    < 1.0 mg/mg
    - For participants with a baseline UPCR > 3.0 mg/mg:
    > 50% improvement from baseline and ≤ 3.0 mg/mg
    - No discontinuation of study intervention or use of restricted medication beyond the protocol allowed threshold before assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and sustained through Week 52.
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    After 1 year, treatment will change based on response.
    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 trial3
    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 EEA46
    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
    Colombia
    Malaysia
    Philippines
    Hong Kong
    Taiwan
    Brazil
    India
    Israel
    Korea, Republic of
    Mexico
    Serbia
    South Africa
    Thailand
    United Kingdom
    United States
    Croatia
    Italy
    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
    The end of study date is defined as the date when the last participant across all sites is assessed (ie, last subject last visit), including any additional parts in the study (eg, long-term follow-up, additional antibody testing), as applicable.
    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 months3
    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 months3
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 210
    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 Decision2023-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-05
    P. End of Trial
    P.End of Trial StatusOngoing
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