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    Summary
    EudraCT Number:2020-000585-41
    Sponsor's Protocol Code Number:OG-061-01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-000585-41
    A.3Full title of the trial
    Effects of tregalizumab on allergen-induced airway responses and airway inflammation in asthmatic patients
    Effekte von Tregalizumab auf allergen-induzierte Atemwegsreaktionen und Atemwegsentzündung bei Patienten mit Asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate tregalizumab effects on allergen-induced airway responses and airway inflammation in asthmatic patients
    A.3.2Name or abbreviated title of the trial where available
    Tregulaire
    A.4.1Sponsor's protocol code numberOG-061-01
    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 SponsorT-Balance Therapeutics GmbH
    B.1.3.4CountryGermany
    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 supportT-Balance Therapeutics GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationT-Balance Therapeutics GmbH
    B.5.2Functional name of contact pointT-Balance Therapeutics GmbH
    B.5.3 Address:
    B.5.3.1Street AddressWaldfriedstrasse 4
    B.5.3.2Town/ cityFrankfurt a. Main
    B.5.3.3Post code60528
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 69 666 8382
    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 nameTregalizumab 100 mg/mL
    D.3.2Product code BT061
    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 INNTREGALIZUMAB
    D.3.9.2Current sponsor codeBT061
    D.3.9.4EV Substance CodeSUB189005
    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 Yes
    D.3.11.13.1Other medicinal product typea humanized IgG1 monoclonal antibody
    D.IMP: 2
    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 Provokit® 0,33%
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameProvokit® 0,33%
    D.3.4Pharmaceutical form Powder and solvent for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHACHOLINE CHLORIDE
    D.3.9.1CAS number 62-51-1
    D.3.9.4EV Substance CodeSUB08832MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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 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
    mild controlled allergic asthma and house-dust mite (HDM) allergy
    E.1.1.1Medical condition in easily understood language
    allergic asthma and house-dust mite allergy
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020419
    E.1.2Term House dust mite allergy
    E.1.2System Organ Class 100000004870
    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 investigate the effect of 100 mg tregalizumab treatment administered weekly (via subcutaneous injection) over 12 weeks to patients with mild controlled allergic asthma and HDM allergy, who have been exposed to allergen induced bronchoconstriction under controlled conditions in this challenge study. The primary endpoint supporting this objective will be the change from baseline in the Late Asthmatic Response (LAR) after BAP
    E.2.2Secondary objectives of the trial
    •Evaluate the Early Asthmatic Response (EAR) after BAP in adult patients with mild controlled allergic asthma and HDM allergy over 12-week treatment with tregalizumab.
    •Determine the anti-inflammatory profile of tregalizumab on the airways in induced sputum, by exhaled nitric oxide (eNO) and in blood after 12-week treatment with tregalizumab;
    •Examine bronchial hyperresponsiveness (BHR) after a methacholine inhalation challenge after 12-week treatment with tregalizumab ;
    •Determine the pharmacodynamics by CD4 modulation and activation of regulatory T cells (Tregs), the pharmacokinetics and immunogenicity of tregalizumab treatment;
    •Assess the safety and tolerability of tregalizumab;
    •Assess the effect of tregalizumab treatment on the asthma-related quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Willing and able to give written informed consent
    2.Male or female subject aged 18 to 65 years (both inclusive).
    3.Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
    4.Body mass index (BMI) of 18.0 to 30.0 (both inclusive).
    5.Non-smoker (all substances).
    6.Specific IgE to HDM > class 2 in radioallergosorbent test (RAST).
    7.BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
    8.FEV1 ≥ 75% of predicted value (according to height, weight and sex).
    9. Subject must demonstrate a significant EAR and LAR without rescue medication use within the first 7 hours after BAP. EAR is defined as a decrease in FEV1 of ≥ 20% within 0 to 3 hours after allergen challenge; LAR is defined as a decrease in FEV1 of ≥ 15% within 4 to 7 hours after BAP.
    10. No clinically relevant abnormalities in 12-lead ECG at screening.
    E.4Principal exclusion criteria
    1.Severe, unstable bronchial asthma.
    2.Exacerbation of asthma ≤ 4 weeks prior to screening.
    3.Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
    4.Treatment with inhaled corticosteroids, methylxanthines (e.g., theophyllin), anticholinergics (e.g., ipratropium bromide), leukotriene modifiers (e.g., montelukast), tiotropium bromide, cromolyn or nedocromil within 2 weeks prior to screening and during the study.
    5.Current treatment with any immunosuppressants (e.g., monoclonal antibodies, methotrexate, cyclosporin).
    6.Specific immunotherapy (SCIT) to mite within 3 years prior to screening.
    7.Serious adverse drug reaction to previous biological treatment.
    8.Previous therapy with a monoclonal antibody (mAb) targeting CD4, including tregalizumab.
    9.Known hypersensitivity to any constituents of tregalizumab, and/or other mAbs, that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
    10.Previous inclusion in this study.
    11.Serum transaminases, alanine transaminase (ALAT) and/or aspartate transaminase (ASAT) > 2.5-fold upper level of normal (ULN) at screening.
    12.Bilirubin > 34.2 µmol/L at screening.
    13.Alkaline phosphatase (AP) > 2-fold ULN at screening.
    14.Urea nitrogen > 1.5-fold ULN at screening.
    15.Kidney insufficiency as defined by creatinine level > 133 µmol/L at screening.
    16.History of severe allergic or anaphylactic reaction to proteins of human origin (e.g. vaccination reaction, biological therapy).
    17.Presence or history of malignancy within the previous 5 years (except completely resected squamous or basal cell carcinoma of the skin).
    18.Presence or history of clinically significant major disease (e.g., severe heart/lung disease New York Heart Association [NYHA] Class ≥ 3, autoimmune disease [apart from rheumatoid arthritis], acute uncontrolled hyper- or hypo-thyroidism, severe uncontrolled hypo or hypertension).
    19.Serious local (e.g., abscess) or systemic (e.g., pneumonia, septicemia) infection or recurrent chronic infections within 6 weeks prior to screening visit or during the screening period.
    20.Any infection requiring antibiotic therapy by any route of administration within 4 weeks prior to screening.
    21.Vaccination with live, live attenuated, and/or killed vaccines in the 12 weeks prior to the first administration of the study drug and during the study.
    22.Positive diagnosis for acute or chronic infections (e.g. Hepatitis C Virus [HCV], Hepatitis B Virus [HBV], Human Immunodeficiency Virus [HIV]) at screening or history of previous chronic infection.
    23.Acute or clinically symptomatic Epstein-Barr Virus (EBV) (infectious mononucleosis) or Cytomegalovirus (CMV) infection.
    24.Presence or history of latent or active tuberculosis.
    25.Known immune deficiency.
    26.Presence or history of lymphoproliferative disease, including lymphoma and lymphadenopathy.
    27.Presence or history of clinically significant drug or alcohol abuse.
    28.Employee at study site or any institution involved in this study (including the sponsor), or spouse/partner or relative of an investigator.
    29.Pregnant or nursing woman or woman considering to become pregnant during the study or in the 3 months after the last administration of study drug.
    30.Woman of childbearing potential (unless surgically sterile or post-menopausal > 52 weeks) who is not using two (2) independent effective contraceptive methods (e.g., oral or injectable contraceptives, intra-uterine devices, double barrier method, contraceptive patch or female sterilization) during the study and for at least 3 months after the last administration of study drug
    OR
    Non-vasectomized man who, during the study or in the 3 months after the last administration of study drug, is not using two (2) independent effective contraceptive methods (as specified above) or is planning a sperm donation.
    31.Donation of blood within 30 days prior to screening until end of study.
    32.Participation in another clinical trial within 90 days before screening or during the study.
    33.Inability or lacking motivation to adhere to the study requirements and to comply with the study schedule.
    34.Imprisonment or placement in an institution (AMG § 40 (1), sentence 4).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the baseline-corrected LAR measured by the area under the curve (AUC) for FEV1 at 4 to 7 hours after BAP (AUC4-7FEV1) on Day 84. The AUC4 7FEV1 will be calculated as the area under the curve of the normalized FEV1 values (post-BAP FEV1 values divided by the pre-BAP FEV1 value in %) over time
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2, Visit 4 and visit 17
    E.5.2Secondary end point(s)
    •Change in LAR on Day 84, as measured from 4 to 7 hours after BAP by the maximum decrease in the normalized FEV1 values;
    •Change in EAR on Day 84, as measured from 0 to 3 hours after BAP by the maximum decrease in the normalized FEV1 values;
    •Change in EAR on Day 84, as measured from 0 to 3 hours after BAP by the AUC of the normalized FEV1 values;
    •Fraction of eNO (FeNO) absolute levels and delta increase after BAP;
    •Dose of methacholine causing a decrease in FEV1 of at least 20% (methacholine PD20);
    •Impact of tregalizumab on TH1, TH2 and TH17 cytokines in serum and sputum and its correlation to LAR in tregalizumab-treated subjects in comparison to placebo;
    •Impact of tregalizumab on known markers of TH2-induced inflammation (total IgE, mite-specific IgE, eosinophils) and eNO in tregalizumab-treated subjects in comparison to placebo after 12 weeks;
    •Mite-specific IgG4 and total IgG after 12 weeks;
    •Induced sputum markers:
    oEosinophils, neutrophils, macrophages and lymphocytes in cytospin samples
    oTH1, TH2 and TH17 cytokines
    oPCR for TH1, TH2 and TH17 cytokines and T-cell transcription factors
    oEosinophil cationic protein (ECP)
    •Impact of tregalizumab on the expression of markers of PBMC lineage;
    •Safety evaluations include the incidence and severity of adverse events (AEs), changes in clinical laboratory profiles, and the serum levels of specific anti-tregalizumab antibodies;
    •Number of rescue ß2-agonist puffs ;
    •VAS Nasal Symptom Score at screening and 12 weeks;
    •Asthma-related quality of life questionnaires [Asthma Control Test (ACT) and Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12)] at 0 and 12 weeks.

    Additional/Exploratory Endpoints
    •Changes in miRNA expression profiles in blood in tregalizumab-treated subjects in comparison to placebo as determined by next generation sequencing (optional);
    •Tregalizumab trough serum levels.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 to Visit 19
    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 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 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 No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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: 42
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state42
    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)
    In case of any abnormal findings on the occasion of the follow-up visit that were assessed as clinically significant or alarming by the investigator, subjects will be invited for further medical investigations for safety reasons.
    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 Decision2020-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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