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    Summary
    EudraCT Number:2021-003327-15
    Sponsor's Protocol Code Number:TIDAM
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-01-19
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003327-15
    A.3Full title of the trial
    An open-label, 8-week, proof of concept trial on thymosin-α1 (thymalfasin) in the treatment of primary antibody deficiency (PAD) associated mood disorders (TIDAM18).
    Een open-label 8-weken proof-of-concept studie met thymosine-α1 (thymalfasin) in de behandeling van primaire antistof deficientie (PAD) geassocieerde stemmingsstoornissen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thymosin-α1 in immunodeficiency associated mood disorders
    Thymosine-α1 in immuundeficientie-geassocieerde stemmingsstoornissen
    A.3.2Name or abbreviated title of the trial where available
    TIDAM
    TIDAM
    A.4.1Sponsor's protocol code numberTIDAM
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportSciClone
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointMedical doctor
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003106 33330457
    B.5.5Fax number0031107031146
    B.5.6E-mailv.dalm@erasmusmc.nl
    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 Thymalfasin
    D.2.1.1.2Name of the Marketing Authorisation holderSciClone Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameThymafalsin
    D.3.4Pharmaceutical form Powder and solution for 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 INNTHYMALFASIN
    D.3.9.1CAS number 62304-98-7
    D.3.9.2Current sponsor codeThymosin-α1
    D.3.9.3Other descriptive nameZadaxin
    D.3.9.4EV Substance CodeSUB10990MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typeimmune stimulating
    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
    Primary immunodeficiency
    Primaire immuundeficientie
    E.1.1.1Medical condition in easily understood language
    Primary immunodeficiency
    Primaire immuundeficientie
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    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 study is to establish in CVID patients with depression the changing, i.e. increasing, effect of Tα1 on the naïve CD4/CD8 ratio.
    Evalueren van het effect van Thymalfasin op herstel van de verlaagde naive CD4/CD8 ratio in CVID patienten met depressie
    E.2.2Secondary objectives of the trial
    -Changes in depression, anxiety, fatigue and quality of life scores
    -Changes in T lymphocyte subsets (such as Th1, Th2, Th17 and T regulatory cells) and T cell regulating cytokines (such as IL-7 and sCD25)
    -Changes in levels of markers of inflammation, such as the hCRP and IL-6 serum levels and the monocyte inflammatory gene expression.
    -Assessment of adverse events.
    -Changes in antibiotic usage
    -Veranderingen in depressive, vermoeidheid en kwaliteit van leven scores
    -Veranderingen in T lymfocyten patronen en cel regulerende cytokines
    -Veranderingen in niveaus van ontstekings markers zoals hCRP an Il-6 serum niveaus en de moncyte onsteking gen expressie.
    -In kaart brengen van bijwerkingen
    -Veranderingen in het gebruik van antibiotica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent must be obtained before any assessment is performed.Suffering from the following condition
    oCommon variable immunodeficiency (CVID), with an established diagnosis according to the diagnostic criteria from the European Society for Immunodeficiences (ESID) 2014, in accordance with the International Union of Immunological Societies (IUIS).
    -Stable and standard use of classical (tricyclic) or non-tricyclic antidepressant (SSRI, SNRI, MAOI, other), with or without mood stabilizer, in a stable dosing regimen for a duration of at least 4 weeks prior to inclusion in the clinical study
    -Presence of a depressive mood disorder as determined by the Hamilton Rating Scale for Depression (HAM-D) (above 12).
    -Age between 18 and 75.
    - Ondertekend troestemmingsformulier Lijdend aan onderstaande aandoening
    - Common variable immunodeficiency (CVID), met een diagnose gesteld op basis van de diagnostische criteria volgens de European Society for Immunodeficienices (ESID) 2014,in overeenstemming met de International Union of Immunological Societies (IUIS).
    - Stabiele en standard gebruik van klassieke (tricyclische) of niet-tricyclissche anntidepressiva (SSRI, SNRI, MAOI, anders), met of zonder stemmingsstabilisator, in stabiele dosering gedurende tenminste 4 weken voorafgaande aan inclusie in de studie
    - Aanwezigheid van een depressieve stemmingsstoornissen, vastgelegd met de Hamilton Rating Scale for Depression (HAM-D) (meer dan 12)
    - Leeftijd tussen 18 en 75 jaar
    E.4Principal exclusion criteria
    - Active, concomitant autoimmune disease clinical manifestations
    - Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI or MDRD formula)
    - Hepatic impairment, i.e. unexplained persistent liver function abnormalities
    - Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN
    - Severe cardiac (LVEF < 45%) and/or pulmonary disease (FVC <50%)
    - History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction
    - Use of other investigational drugs, within 5 half-lives of enrollment or within 30 days, whichever is longer
    - History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
    - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 days after last dose of study medication.
    - History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical cancer.
    - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    - Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial.
    - Actieve gelijktijdige autoimmuunziekte met klinische verschijnselen
    -Nierfunctiestoornissen met een geschatte klaring van minder dan 30 ml/min (gebruikmakend van CKD-EPI of MDRD formule)
    -Levertestafwijkingen, i.e. ionverklaarde en persisterende leverfunctiestoornissen
    -Labratoriumafwijkingen op visite voor starten van behandeling met een of meer vand e volgende afwijkingen: transaminases >2x boven de maximale normaalwaarde en/of bilirubine >2x boven de maximale normaalwaarde
    -Cardiale dysfunctie (met linkerventrikelejectiefractie <45%) en/of longfunctiestoornissen met een FVC<50% van normal
    -Historie van hartfalen, symptomatisch coronairlijden, ventriculaire tachyaritmie, stentplaatsing, coronairarterie bypassoperatie en/of hartinfarct
    -Gebruik van andere geneesmiddelen in wetenschappelijk onderzoek voor starten van deze studie (minimal 5x halfwaardetijd of 30 dagen voorafgaande aan start onderzoek)
    -Voorgeschiedenis van overgevoeligheid voor de studiebehandeling of geneesmiddelen van dezelfde klasse
    -Zwangerschap of lactatie
    -Vrouwen in de vruchtbare leeftijd, tenzij er adequate anticonceptie wordt gebruikt, tijdens en tot 2 dagen na gebruik van de studiemedicatie
    -Maligniteit in de laatste 5 jaar voorafgaande aan stafrten van studie, behalve gereserceerde basal of plaveiselcelcarcinoom van de huid, behandelde cervicale dysplasia
    -Een psychologische, familiaire, sociologische of geografische situatie die mogelijke compliantaie aan de stude in de weg staat
    -Elke conditie of behandeling welke in de ogen van de hoofdponderzoeker een patient aan een onacceptable risico blootstelt
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of this study will be the increase in the naïve CD4+/CD8+ ratio, measured after 8 weeks of treatment and 8 weeks after termination of the treatment period (i.e. 16 weeks after initiation of treatment)
    Primaire uitkomst van deze studie is de stijging van de naive CD4+/ CD8+ ratio, gemeten na 8 weken behandeling en 8 weken na beeindiging van de klinische studie/behandelperiode
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated 8 weeks after start treatment and 8 weeks after termination of the treatment.
    Het primaire eindpunt zal 8 weken na start studiebehandeling en 8 weken na beeindiging van de behandeling geevalueerd worden.
    E.5.2Secondary end point(s)
    EFFICACY
    1) Change in depression scores (Hamilton Depression Scale (HAM-D) scores) from baseline to week 8 and at 8 weeks after termination of the clinical study (i.e. 12 weeks after initiation of treatment)..
    2) Change in fatigue scores (Fatigue Severity Scale (FSS)) from baseline to week 8 and at 8 weeks after termination of the clinical study (i.e. 12 weeks after initiation of treatment).
    3) Change in health-related quality of life scores (SF36, CVID_QoL) from baseline to week 8 and at 8 weeks after termination of the treatment period (i.e. 12 weeks after initiation of treatment).
    4) Increase/decrease in numbers of Th1, Th2 and Th17 cells
    5) Alterations in the balance between naïve and memory T helper cells
    6) Alterations in the balance between the Th17/T regulatory cells
    7) Decrease in inflammatory gene expression (cluster 1 and 2 gene expression) in circulating monocytes
    8) Decrease in circulating levels of hCRP, IL-6, sCD25, IL-7, BDNF
    SAFETY
    9) Frequency and type of adverse events
    10) Lab tests: mean change and frequency of values outside the normal range (hematology, liver and kidney biochemistry)
    11) Changes in the antibiotic usage
    Effectiviteit
    1) Verandering in depressie scores (Hamilton Depression Scale (HAM-D) scores) op baseline, na 8 weken behandeling en 8 weken na beeindiging van de klinische studie
    2) Verandering in vermoeidheidsscores (Fatigue Severity Scale (FSS)) op baseline, na 8 weken behandeling en 8 weken na beeindiging van de klinische studie
    3) Verandering in gezondheidsgerelateerde kwalitiet van leven scores (SF36, CVID, QoL)
    4) Toename/afname in het totaal aantal Th1, Th2 en Th17 cellen
    5) Verandering in de verhouding tussen naieve en geheugen T helper cellen
    6) Verandering in de balans tussen de Th17/regulatoire T cellen
    7) Afname in expressie van inflammatoire genen (cluster 1 en 2 gen expressie profielen) in circulerende leukocyten
    8) Afname in circulerende levels hCRP, IL-6, CCL2, PTX-3, sCD25, SCF, BDNF
    Veiligheid
    9) Frequentie en type bijwerkingen
    10) Laboratoriumtesten: Gemiddelde verandering en frequentie van waarden buiten referentiewaarden
    11) Veranderingen in het gebruik van antibiotica
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated 8 weeks after start treatment and 8 weeks after termination of study treatment.
    De secundaire eindpunten zullen 8 weken na start studiebehandeling en 8 weken na beeindiging van de behandeling geevalueerd worden.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    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 No
    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 No
    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. The trial will end when the last subject completes the last visit discontinues form the trial or is lost to follow up
    LVLS. The studie zal eindigen als het laatste subject de laatste visite heft afgerond of niet meer deelneemt aan de trial of geen follow up kan ondergaan.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months31
    E.8.9.1In the Member State concerned days
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state20
    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)
    As the study treatment is currently not available in the Netherlands and not registered for the studied indication, study participants will not be able to continue the study treatment and will be treated according to the current standards of treatment for this clinical condition
    De studiebehandeling is niet geregistreerd in Nederland, waardoor deelnemers na beeindiging van de studie niet door kunnen gaan met de behandeling. Zij zullen daarom behandeled worden volgens de huidige standaarden voor deze aandoening.
    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 Decision2022-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
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