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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2008-002221-36
    Sponsor's Protocol Code Number:28779
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-19
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-002221-36
    A.3Full title of the trial
    A Phase II/III, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of atacicept in combination with corticosteroids and sequential therapy with cyclophosphamide and azathioprine in subjects with lupus nephritis
    A.3.2Name or abbreviated title of the trial where available
    Atacicept in combination with sequential cyclophosphamide and azathioprine in active LN Phase II/III
    A.4.1Sponsor's protocol code number28779
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono International, An affiliate of Merck KGaA, Darmstadt, Germany
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameatacicept (formerly known as TACI-Fc5)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNAtacicept
    D.3.9.1CAS number 845264-92-8
    D.3.9.3Other descriptive nameTACI-Fc5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Lupus Nephritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to evaluate the efficacy of atacicept compared to placebo in subjects with active LN who are receiving corticosteroids and sequential therapy with cyclophosphamide (CY) and azathioprine (AZA).
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to evaluate the safety and tolerability profile of atacicept in subjects with active LN who are receiving corticosteroids and sequential therapy with CY and AZA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of SLE satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria
    2. Positive test results for ANA (HEp-2 ANA ≥1:80) and/or anti-dsDNA (≥30 IU/mL) at
    3. Renal biopsy performed at or within 3 months before screening with histological findings consistent with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV (A or A/C) LN (results must be available during screening).
    4. Active LN as defined by proteinuria (urine protein:creatinine ratio >1.0 mg/mg) and
    haematuria (>5 RBCs/hpf). These results must be available during screening. All causes of haematuria other than active LN must be excluded according to the local standard of care.
    5. Male or female of ≥18 years of age.
    6. Written informed consent, given before any trial-related procedure. Subjects must have read and understood the informed consent form, must fully understand the requirements of the trial, and must be willing to comply with all trial visits and assessments.
    7. Female subjects must have avoided pregnancy for at least 4 weeks before the screening visit, and must be willing to avoid pregnancy for the duration of the trial (until 24 weeks after the last dose of trial medication) by using an adequate method of contraception. This requirement does not apply to surgically sterile subjects or to subjects who are postmenopausal for at least 2 years. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device or a female hormonal contraceptive.
    8. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Study Day 1 before dosing. For the purpose of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least 2 years or surgically sterile.
    E.4Principal exclusion criteria
    1. Significant renal disease unrelated to SLE (e.g., diabetes mellitus or renovascular disease, whether or not associated with antiphospholipid syndrome).
    2. Estimated GFR ≤30 mL/min per 1.73 m2 (as calculated by the modified MDRD equation) at screening, unless it is documented that all GFR values from the
    12 weeks before screening are >30 mL/min per 1.73 m2.
    3. Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol.
    4. Comorbidities requiring systemic corticosteroid therapy (such as asthma or inflammatory bowel disease) and/or preventing engagement in trial conduct.
    5. Any treatment with CY within the last 12 months before the screening visit.
    6. Known intolerance/toxicity to CY, AZA, or to both ACE inhibitors (ACEi) and
    angiotensin receptor blockers (ARB).
    7. Treatment with MMF, azathioprine or methotrexate within 2 weeks before screening.
    8. Treatment with IV steroids within 2 weeks before screening.
    9. Treatment with oral steroids at a dose >0.5 mg/kg/day of prednisolone (or equivalent) within 30 days before screening.
    10. Any prior treatment with abatacept, rituximab, belimumab or other B-cell modulating agents.
    11. Treatment with other investigational agents within the last 12 months
    12. Any condition, including laboratory findings and findings in the medical history or in the screening assessments, that, in the opinion of the Investigator, constitutes a risk or a contraindication for participation in the trial or that could interfere with the trial’s objectives, conduct, or evaluation.
    13. Active gastroduodenal ulcers.
    14. History of or planned renal transplant.
    15. Known active clinically significant infection, or any major episode of infection requiring hospitalisation or treatment with parenteral anti-infectives within 4 weeks of screening or completion of oral anti-infectives within 2 weeks before screening.
    16. Positive HIV, hepatitis C, or hepatitis B (HBsAg) serology.
    17. Active tuberculosis.
    18. Latent tuberculosis, diagnosed according to local guidelines, unless this has been treated or is currently being treated according to the local standard of care.
    19. Diagnosis or family history of Creutzfeldt-Jakob disease (CJD).
    20. History or presence of uncontrolled or New York Heart Association (NYHA) class 3 or 4 congestive heart failure. [NYHA class 3: Cardiac disease resulting in marked limitation of physical activity. Subjects are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnoea, or anginal pain. NYHA class 4: Cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.]
    21. History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
    22. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or total bilirubin >1.5 x ULN unless attributable to active SLE.
    23. Clinically significant abnormality in any haematological test (for example, haemoglobin <5.5 mmol/L [9 g/dL], WBC <2.5 x 109/L [2500/mm3], platelets <75 x 109/L [75,000/mm3]) unless attributable to active SLE.
    24. Serum IgG below 4 g/L, unless attributable by the investigator to proteinuria.
    25. Clinically significant abnormality on chest X-ray performed within 3 months before
    screening (if allowed by local guidelines and regulations) or on electrocardiogram (ECG) performed at screening that is considered by the Investigator to constitute a risk or a contraindication for participation in the trial.
    26. Hypersensitivity to any of the components of the formulated atacicept.
    27. Immunisation with live vaccines or Ig treatment within one month before screening.
    28. Planned major surgery during the trial period (including trial follow-up).
    29. History of alcohol or drug abuse in the last 6 months before screening.
    30. Breastfeeding or pregnancy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with confirmed CR(ACR) at Week 52.

    Complete Response as per ACR guidelines (CR(ACR)):
    - Normalisation of renal function based on calculated GFR within 10% of the normal value of 90 mL/min/1.73 m2,
    - Improvement in proteinuria, defined as a urine protein:creatinine ratio of <0.2 mg/mg,
    - Improvement in haematuria, defined as urine sediment of <or=5 red blood cells (RBCs)/high powered field (hpf) and no RBC casts.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    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 EEA45
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    For administrative and safety reporting purposes, the end of the trial will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all trial sites.
    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 months7
    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 months7
    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.1.3Elderly (>=65 years) Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 274
    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)
    Extended treatment plans are under consideration by the Sponsor
    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 Decision2008-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-20
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