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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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:2019-004998-34
    Sponsor's Protocol Code Number:B-2660-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-02-04
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2019-004998-34
    A.3Full title of the trial
    A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary Fibrosis
    A.3.2Name or abbreviated title of the trial where available
    B-2660-203
    A.4.1Sponsor's protocol code numberB-2660-203
    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 SponsorBlade Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportBlade Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBlade Therapeutics, Inc.
    B.5.2Functional name of contact pointDaven Mody
    B.5.3 Address:
    B.5.3.1Street Address442 Littlefield Avenue
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number(650) 797-0282
    B.5.5Fax number(650) 745-0887
    B.5.6E-maildmody@blademed.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 nameBLD-2660
    D.3.2Product code BLD-2660
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone
    D.3.9.2Current sponsor codeBLD-2660
    D.3.9.3Other descriptive nameBLD-2660
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis
    E.1.1.1Medical condition in easily understood language
    A type of lung disease that results in scarring (fibrosis) of the lungs for unknown reason. Overtime, it becomes hard to take in a deep breath and the lungs cannot take enough oxygen.
    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 PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY OBJECTIVE
    • To establish the study drug interaction with its intended target in cells isolated from Bronchoalveolar lavage
    • To evaluate biochemical and physiologic effects of the study drug (Pharmacodynamics) and to evaluate the indicators or markers in the blood (Biomarkers) and Bronchoalveolar lavage fluid.
    E.2.2Secondary objectives of the trial
    • To study how the BLD-2660 enters, moves through and exits the body (Pharmacokinetics) in IPF subjects.
    • To establish safety and tolerability of BLD-2660 in subjects with IPF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion into this study, each subject must fulfil the following inclusion criteria within 20 days prior to Randomisation on Day 1.

    Age and Gender
    1. Male subjects 45 years of age and over, or female subjects 50 years of age and over, at the time of signing the informed consent.

    Diagnosis and disease characteristics
    2. Subjects with diagnosis of IPF as defined by the American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of Idiopathic Interstitial Pneumonia (Raghu, 2018).
    3. FVC >45% predicted and diffusing capacity of the lung for carbon monoxide (DLCO) >30% predicted.
    4. Alanine aminotransferase (ALT) within normal limits (WNL).
    5. Aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤1.2 × upper limit of normal (ULN).
    6. Total bilirubin ≤ULN (isolated bilirubinemia ≤2× ULN is acceptable if direct bilirubin to total bilirubin ratio <0.35).
    7. Body mass index (BMI) up to 35 kg/m2 inclusive.

    Reproductive Considerations
    Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    8. All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study, including:
    • intrauterine device (IUD);
    • bilateral tubal occlusion;
    • vasectomised partner a;
    • sexual abstinence b.
    Notes: a Vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the women of childbearing potential (WOCBP) trial participant and that the vasectomised partner has received medical assessment of the surgical success.
    b Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
    Hormonal contraceptives (HC) are restricted during the study.

    9. Male subjects and female partners of male subjects must continue to use highly effective contraception, as listed in Inclusion criterion 8, for 90 days after the last dose of study drug. Male subjects must agree not to donate sperm for 90 days after last dose of study drug.
    10. Female subjects and male partners of female subjects must continue to use highly effective contraception, as listed in Inclusion criterion 8, for 60 days after the last dose of study drug. Female subjects should not donate oocytes during this time.
    11. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day (-1). WOCBP must agree to undergo pregnancy testing at regular intervals throughout the study.
    12. Female subjects not of childbearing potential as defined by being postmenopausal (with cessation of regular menstrual periods for at least 1 year), confirmed by follicle stimulating hormone (FSH) level, or be surgically sterile.

    Informed Consent
    13. Subjects must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.
    E.4Principal exclusion criteria
    To be eligible for inclusion into this study, each subject must violate none of the following exclusion criteria within 20 days prior to Randomisation on Day 1:

    Medical Conditions
    1. Recent (less than 6 weeks) significant wound (in the opinion of the Investigator), or presence of an ongoing non-healing skin wound or ulcer.
    2. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol.
    3. Active infection (diagnosed or suspected) or history of recurrent infections, including but is not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, cellulitis or chronic ongoing infectious disease within 4 weeks prior to first dose of study drug.
    Note: Rescreening will be permitted after 28 days if an infection leads to screening failure.
    4. Active malignancy and/or history of malignancy in the past 5 years, except for non-melanoma skin cancer, carcinoma in situ of the breast that has been successfully treated, carcinoma in situ of the cervix that has been successfully treated, early stage, untreated prostate cancer, or prostate cancer with completion of treatment >2 years prior to Screening.
    5. Extensive chronic obstructive pulmonary disease (where extent of emphysema >extent of fibrosis on computerised tomography (CT) scan or FEV1: FVC ratio <0.65).
    6. Other explanation for lung fibrosis, including but not limited to radiation, sarcoidosis, bronchiolitis obliterans organizing pneumonia, collagen vascular disease, hypersensitivity pneumonitis, etc.
    7. IPF exacerbation within last 60 days.
    8. A history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subjects’ participation for the full duration of the study, or is not in the best interest of the subjects to participate, in the opinion of the Investigator.

    Diagnostic Assessments
    9. Positivity for Human Immunodeficiency Virus (HIV) antibody (HIV-1 and/or HIV-2) and/or HIV-1 p24 antigen.
    10. Positivity for Hepatitis C virus antibody (HCV Ab or anti-HCV) and/or Hepatitis B surface antigen (HBsAg).
    11. Absolute neutrophil count <1700/μL.
    12. Significant hypoxia, requiring >2 L/min oxygen to maintain a resting oxygen saturation >89%.
    13. Poor exercise tolerance.
    14. Serum troponin I level >ULN.

    Prior/Concomitant Therapy
    15. Use of anticoagulants that prolong Prothrombin time (PT)/ International normalised ratio (INR).
    16. Use of anticoagulants within 2 days of Day (-1) (bronchoscopy)
    Note: The subjects who cannot discontinue the anticoagulants within 2 days of Day (-1) bronchoscopy will be excluded.
    17. Treatment with any anti-fibrotic therapy (pirfenidone or nintedanib) within 30 days of Screening.
    18. Immunosuppressive therapy within 3 months prior to first dose of study drug unless for non-IPF indication).
    19. Use of oral steroids >10 mg/day (or prednisolone equivalent).
    Note: If the subject is on steroid dose equivalent to 10 mg/day prednisone or more, the Investigator may decide if the tapering down to the dose of 10 mg/day prednisone is possible and safe.
    20. Start of new biologic or change in biologic dose within 24 weeks prior to Day 1.
    21. Cyclophosphamide within 6 months prior to the first dose of study drug (unless for other indication).

    Prior/Concurrent Clinical Study Experience
    22. Administration of another investigational product, investigational device, or approved therapy for investigational use within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.

    Other Exclusions
    23. Blood donation or significant blood loss within 60 days prior to the first study drug administration.
    24. Plasma donation within 7 days prior to the first study drug administration.
    25. Females who are pregnant or breastfeeding.
    26. History or presence of alcohol or drug abuse (including recreational marijuana use) within the 2 year prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
    27. Active smoker, smoking history or vaping within 4 weeks prior to the first dose of study drug. Subjects only using Nicotine replacement therapy (NRT) may be allowed per discretion of the Investigator.
    28. Subjects with an allergy to BLD-2660 or inactive components of BLD-2660.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the study are:
    • Change from baseline in calpain substrates, (i.e., ILK, spectrin, ezrin and/or S100A9) in BAL cells;
    • Change from baseline in downstream PD biomarkers (e.g. PAI-1, IL-6, and/or CCL18) in BAL fluid;
    • Change from baseline in blood biomarkers that correlate with collagen formation and degradation including Pro-C3, C1M and C3M.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Change from baseline in calpain substrates, (i.e., ILK, spectrin, ezrin
    and/or S100A9) in BAL cells - Evaluated on Day (-1) and Day 27
    • Change from baseline in downstream PD biomarkers (e.g. PAI-1, IL-6,
    and/or CCL18) in BAL fluid -
    Evaluated on Day (-1) and Day 27
    • Change from baseline in blood biomarkers that correlate with collagen
    formation and degradation including Pro-C3, C1M and C3M - Evaluated
    on Day (-1), 27 and 42
    E.5.2Secondary end point(s)
    Pharmacokinetic Endpoints:
    • PK parameters to be estimated on Days 1 and 28 by noncompartmental analysis (NCA) are: maximum plasma concentration
    (Cmax), time to Cmax (Tmax), and area under the curve to the final concentration ≥ Lower Limit of Quantification [LLOQ] (AUC0-t) or to the end of the 12-hour dosing interval (AUC0-12). Additional analyses may be performed as deemed necessary upon review of the data;

    Safety Endpoints:
    • Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs);
    • Changes from baseline in electrocardiogram (ECG), vital signs, physical examinations and the following clinical laboratory values: haematology, clinical chemistry, coagulation and urinalysis;
    • Proportion of subjects with troponin elevations leading to discontinuation of study drug;
    • Proportion of subjects with troponin elevations that persist on retesting as >first elevated troponin value while still on study drug.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic Endpoints evaluated on Days 1 and 28
    Safety Endpoints evaluated during each study visit
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Safety, PK, PD and Target Engagement Study with dose de-escalating design
    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 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 Yes
    E.8.2.3Other No
    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 concerned6
    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
    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 days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Post-trial provision of the IMP was not considered at time of this application.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-14
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