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    Summary
    EudraCT Number:2019-004683-22
    Sponsor's Protocol Code Number:RGCH005
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-29
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-004683-22
    A.3Full title of the trial
    Daratumumab as a treatment for adult immune thrombocytopenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daratumumab as a treatment for adult immune thrombocytopenia
    A.3.2Name or abbreviated title of the trial where available
    The DART-study
    A.4.1Sponsor's protocol code numberRGCH005
    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 SponsorOstfold Hospital Trust
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOstfold Hospital Trust
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportRegional Health Authority South East
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOstfold Hospital Trust
    B.5.2Functional name of contact pointSykehuset Østfold
    B.5.3 Address:
    B.5.3.1Street AddressKalnesveien 300
    B.5.3.2Town/ cityGrålum
    B.5.3.3Post code1714
    B.5.3.4CountryNorway
    B.5.4Telephone number+4769860000
    B.5.6E-mailpostmottak@so-hf.no
    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 Yes
    D.2.1.1.1Trade name Darzalex
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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.3.4Pharmaceutical form Solution for injection
    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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJnJ 54767414
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immune thrombocytopenia
    E.1.1.1Medical condition in easily understood language
    An autoimmune disease characterized by low platelet count and increased risk of bleeding.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectives safety run-in
    • to assess safety and tolerability of daratumumab in patients with ITP.- Other objectives as main study.

    Objectives main part
    • to determine the efficacy of treatment with daratumumab defined as response at week 12 for safety run-in and cohort 1, and week 16 for cohort 2.
    • to characterize the safety of daratumumab in patients with ITP.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    -to assess rates of sustained response (sR) at week 24.-to assess the duration of response (DOR)
    -•To determine the time to treatment failure (TTF)
    -•To assess bleeding complications during the study. Exploratory objectives:
    •to characterize immunological effects of daratumumab treatment:
    -to characterize various subsets of immunocompetent cells in the bone marrow and blood before and during daratumumab therapy and at study week 24 (only peripheral blood). • -to identify a potential biomarker (whether or not changes to antibody levels or levels of immuno-competent cells correlate with response). • to determine HRQoL and level of fatigue before and after treatment with daratumumab and to assess difference in HRQoL and fatigue between patients with or without response, prior to and after daratumumab.• To assess time from first dose of study medication to first platelet count >50x109/L• To assess rates of complete and partial response (CR) to daratumumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged ≥18 years.
    2. Primary ITP with a platelet count of ≤30 X 109/L measured within 2 weeks prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab (last infusion ≥24 weeks before study inclusion) and/or TPO-RA. The dose of steroids or/and TPO-RAs (romiplostim, eltrombopag and avatrombopag) has not been changed during the last 2 weeks preceding the inclusion. For the safety run-in phase, a platelet count of 15-30 X 109/L will be required.
    3. Signed and dated written informed consent.
    4. Females of child-bearing potential accepting to follow effective contraceptive methods for at least 24 weeks following the administration of first daratumumab injection. A man who has not had a vasectomy and who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control e.g. condom with spermicidal foam/film/gel/cream/ suppository, and all men must also not donate sperm during the study and for 3 month following discontinuation of Daratumumab (for details see appendix VII).
    E.4Principal exclusion criteria
    1. Patients with active bleeding during the last 7 days prior to inclusion. Active bleeding is defined as any clinically overt hemorrhage (including radiologically diagnosed bleeding) with ongoing hemoglobin fall or bleeding requiring immediate intervention.
    2. Pregnancy or lactation.
    3. Surgery planned within the 3 next months.
    4. Secondary ITP: ITP associated with lymphoma, chronic lymphocytic leukemia, drug induced or ITP secondary to autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, common variable immune deficiency, human immunodeficiency virus, or hepatitis C.
    5. Concomitant autoimmune hemolytic anemia.
    6. Known allergy and/or sensitivity or contraindication to daratumumab.
    7. Current active malignancy likely to require chemotherapy or surgical treatment during the study period or within one year after the start of the study treatment.
    8. Patients with history of poor compliance or history of alcohol/drug abuse or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
    9. Patient unable to attend all the visits planned for the trial.
    10. Positive at screening for hepatitis B virus (HBV) surface and core antibodies unrelated to vaccination:
    - patients with positive HBV surface antigen (HbsAg) are not eligible
    - patients who are HbsAg negative and HBV core antigen antibody positive (HBcAg) will be tested for HBV surface antibody (HBsAb) and HBV DNA. If HBsAb titer is >1000 IU/ml, patients may be enrolled. Monthly HBV DNA monitoring will be required while on treatment and for the 6 months after the last dose of the study drug.
    - patients who are HBcAb positive, HBsAg negative with HBsAb titer <100 IU/ml or negative, are not eligible.
    11. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD.
    12. Known moderate or severe persistent astma within the past 2 years, uncontrolled asthma of any classification.
    13. Patient participating in another clinical trial with an investigational drug.
    E.5 End points
    E.5.1Primary end point(s)
    End points safety run-in
    Safety and tolerability defined as:
    1. Treatment-emergent adverse events/ serious adverse events (TEAEs/SAE) incl. hematological treatment related adverse events.
    2. Incidence of platelet counts decrease during the treatment and up to 2 weeks after the treatment.
    3. Incidence of abnormal changes from baseline in laboratory values per CTCAE criteria V 5.0 (e.g., hematology, chemistry).


    End points main part
    • response after daratumumab treatment defined as:
    o • Safety run in and Cohort 1: proportion of patients who achieve platelet count ≥50x109/L in 2 measurements (taken at least 24 hours apart) during week 12 (after first study drug injection), without having received rescue therapy for the last 4 weeks, nor having had dose increment of TPO-RA or corticosteroids during the study period.
    • Cohort 2: proportion of patients who achieve platelet count ≥50x109/L in 2 measurements (taken at least 24 hours apart) during week 16 after first study drug injection without having received rescue therapy for the last 4 weeks , nor having had dose increment of TPO-RA or corticosteroids during the study period.

    • safety assessed by the incidence, severity and relationship of treatment emergent adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main part: 12 or 16 weeks
    E.5.2Secondary end point(s)
    Secondary end points:
    • Sustained response (sR) defined as platelet count ≥ 50x109/L in 2 measurements (taken at least 24 hours apart) measured at study week 24 (+/-2 weeks) without having received any platelet elevating therapy or having had dose increment of TPO-RA and/or corticosteroids.
    • DOR defined as the duration of sustained platelet count ≥50x109/L without having received any platelet elevating therapy or having had dose increment of TPO-RA and/or corticosteroids. Duration will not consider the 4 weeks following the last daratumumab injection in the study. . Loss of response is defined as platelet count < 50 x 109/L after achieving response, in 2 consecutive blood samples taken at least 24 hours apart.
    • TTF defined as the time with platelet count ≥50x109/L from 4 weeks after the last daratumumab injection to the first platelet count <30x109/L of two counts taken in two consecutive measurements at least 24 hours apart, or administration of any platelet elevating therapy after achieving response. Date of first platelet count measurement or administration of platelet elevation therapy will be used for the calculation of TTF.• -Total number of bleeding episodes per patient. A bleeding episode is defined as any bleeding other than cutaneous, i.e. any bleeding episode of WHO grade >1.
    -Maximum severity on the World Health Organisation (WHO) bleeding scale -Change in Khellaf score measured at the day of first daratumumab administration and at week 24 evaluation.
    Exploratory end points:
    • Level of anti-GPIIb/IIIa and Ib antibodies before daratumumab therapy and at study week 24 for all included patients.
    • Analysis of platelet bound antibodies and functional testing of immunocompetent cells in peripheral blood and bone marrow before, during daratumumab therapy and at study week 24 (only peripheral blood). Platelet bound antibodies will also be tested at study week 8 (safety run-in), week 12 (cohort 1), at study week 16 (cohort 2).
    • Measurement of HRQoL and fatigue using SF36v1 and MFI-20 questionnaire before daratumumab therapy, at week 8 for safety run-in, at week 12 for cohort 1, at week 16 for cohort 2 and at study week 24 for all patients in the study.-• Time to first platelet count >50x109/L measured from the day of first administration of study medication. • Rates of complete response defined as a proportion of patients with platelet count >100x 109/L determined at week 12 for the safety run-in and cohort 1, week 16 for cohort 2 and week 24 for all patients (requires two measurements taken at least 24 hours apart) without having received rescue therapy after week 8, or having had dose increment of corticosteroids or TPO-RA during the study period.• Rates of partial response defined as a proportion of patients with platelet count >30 x 109/ but <50x 109/L (or at least doubling of the platelet count from baseline, determined at week 12 for the safety run-in and cohort 1, week 16 for cohort 2 and week 24 for all patients (requires two measurements taken at least 24 hours apart) without having received rescue therapy after week 8, or having had dose increment of corticosteroids or TPO-RA during the study period
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks (safety run-in), 12 weeks, 16 weeks and 24 weeks or end of study.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cohort 1: 1800mg daratumumab once a week x 8 (8 weeks). Cohort 2: daratumumab 1800mg x 10 (12 weeks)
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    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 Decision2020-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-06
    P. End of Trial
    P.End of Trial StatusOngoing
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