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    Summary
    EudraCT Number:2018-002136-24
    Sponsor's Protocol Code Number:0157
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-03-30
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2018-002136-24
    A.3Full title of the trial
    A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis
    A.4.1Sponsor's protocol code number0157
    A.5.4Other Identifiers
    Name:US INDNumber:128299
    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 SponsorTheravance Biopharma Ireland Limited
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma Ireland Limited
    B.5.2Functional name of contact pointClinical Operations - CC
    B.5.3 Address:
    B.5.3.1Street AddressConnaught House 1 Burlington Road
    B.5.3.2Town/ cityDublin 4
    B.5.3.3Post code D04 C5Y6
    B.5.3.4CountryIreland
    B.5.4Telephone number35315532500
    B.5.5Fax number35315532501
    B.5.6E-mailIBDstudies@theravance.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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form Coated tablet
    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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form Coated tablet
    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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 3
    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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form Coated tablet
    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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboCoated tablet
    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
    Moderately-to-Severely Active Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 2b Dose-Finding Induction
    • Assess the effect of TD-1473 taken daily for 8 weeks at daily doses of 20 mg, 80 mg, and 200 mg on the change in total Mayo score
    • Assess the effect of TD-1473 on rates of clinical remission, endoscopic healing, clinical response, and mucosal (ie, histologic and endoscopic) healing
    • Upon completion, select dose(s) of TD-1473, based on safety, tolerability, and efficacy data, including exposure-response data, for continued evaluation in the Phase 3 dose-confirming Induction Study and the Phase 3 Maintenance Study

    Phase 3 Dose-Confirming Induction
    • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at Week 8
    • Assess the safety and tolerability of TD-1473 taken for up to 16 weeks

    Maintenance phase
    • Assess the clinical remission rates associated with TD-1473 compared to placebo treatment at mWeek 44
    • Assess the safety and tolerability of TD-1473 with up to 44 additional weeks of treatment
    E.2.2Secondary objectives of the trial
    Phase 3 Dose-Confirming Induction
    Assess the rates of the following associated with TD-1473 compared to placebo treatment:
    • Endoscopic healing, symptomatic remission, clinical response, and mucosal healing (endoscopic and histologic) at Week 8
    • Assess at Week 16 the clinical response rate following extended induction treatment with TD-1473 in subjects who did not demonstrate clinical response at Week 8

    Phase 3 Maintenance
    Assess the rates of the following associated with TD-1473 compared to placebo treatment:
    • Clinical response, endoscopic healing, symptomatic remission, and mucosal healing at mWeek 44
    • Corticosteroid-free remission at mWeek 44
    • Maintenance of clinical remission at mWeek 44 in those who were in clinical remission at mWeek 0
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Genetic Test
    An optional genetic testing will be performed in all subjects who agree to participate and provide their additional specific consent. The genetic blood sample should be collected at the Day 1 visit
    E.3Principal inclusion criteria
    1. Are male or female 18 years of age or older at Screening
    2. Has ≥ 3 months history of UC prior to screening (with involvement beyond the rectum to at least 15 cm from the anal verge)
    a. Diagnosed by sigmoidoscopy or colonoscopy AND
    b. Corroborated by histology report or documentation of histological results in a physician note. If neither is available, the subject must have a colonoscopy instead of a sigmoidoscopy at screening.
    3. Must be willing to have a sigmoidoscopy or colonoscopy at screening. Colonoscopy will be performed instead of a sigmoidoscopy at screening in the following scenarios: a. If UC diagnosis precedes screening by ≥ 8 years for pan-colitis or ≥12 years for left-sided colitis and the subject does not have documentation of a surveillance colonoscopy within 12 months prior to screening to rule out dysplasia (report must be reviewed by the investigator and included in the source documents). During colonoscopy, if chromoendoscopy or surveillance biopsies are indicated as per locally adopted guidelines, these should be performed.
    b. If UC diagnosis precedes screening by < 12 years and the subject does not have documentation of a colonoscopy within 2 years prior to screening (report must be reviewed by investigator and included in the source documents).
    c. If chromoendoscopy has to be performed or ≥ 10 biopsies are to be collected for dysplasia surveillance, either should be done after completion of a full colonoscopy to avoid chromoendoscopy dye or biopsy-related bleeding artifact from interfering with endoscopic images for central reading.
    4. Has moderately-to-severely active UC, defined as having a centrally read Mayo endoscopic sub score of ≥ 2 points based on the results of the Screening Stage 2 endoscopy and an adapted Mayo score between 4 and 9 points, inclusive, on Day 1.
    5. Is corticosteroid-dependent or had intolerance or inadequate response to any of the following: aminosalicylates, corticosteroids, immunomodulators (azathioprine or 6-mercaptopurine), or biologics (anti-TNF or anti-integrin) [Refer to Appendix 7 of the protocol]
    6. If currently receiving an oral corticosteroid, subject is eligible if:
    a. the subject has been on corticosteroids for a minimum of 4 weeks prior to Day 1 AND
    b. the dose is equivalent to or less than prednisone 25 mg/day or beclomethasone diproprionate (ie, Clipper) at 5 mg/day or budesonide 9 mg/day AND
    c. the dose is stable for at least 2 weeks prior to Screening Stage 2 visit
    7. If subject is currently receiving oral aminosalicylate (eg, mesalamine products, balsalazide, or sulfasalazine): subject is eligible provided the subject has been on it at a stable dose for ≥ 4 weeks prior to Day 1.
    8. During the Study and for 7 days after receiving the last dose of the Study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at screening and at Day 1 (Refer to Section 4.3 of the protocol).
    9. All male subjects must agree to refrain from semen donation during the Study and for 7 days after the last dose of Study drug.
    10. Must be able and willing to adhere to the Study visit schedule and comply with other protocol requirements.
    11. Are capable of providing informed consent, which must be obtained prior to any Study-related procedures.

    Inclusion Criteria for Extended Induction (additional 8 weeks):
    12. Did not meet criteria for clinical response by adapted Mayo score using centrally read endoscopic subscore at Week 8a

    Inclusion Criteria for Maintenance Study:
    13. Must have met the criteria for a clinical response by adapted Mayo score using centrally read endoscopic sub score during Induction at Week 8a or during Extended Induction at Week 16.
    E.4Principal exclusion criteria
    Induction Studies and Maintenance Study Exclusion Criteria (Please refer to the protocol for the complete list of exclusion criteria)
    Subjects may not be enrolled if they:
    1. Has symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
    2. Has primary sclerosing cholangitis (PSC)
    3. Is likely to require surgery for UC or any other type of major surgery (ie, surgical procedure requiring general anesthesia) during the Study
    4. Has had a clinically significant, as deemed by the investigator, prior intestinal resection for UC or other gastrointestinal diseases
    5. Has carried or carries a diagnosis of Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess.
    6. Has a history of colonic mucosal dysplasia;
    7. Taken or taking any prohibited medications as listed in the protocol
    8. If subject has recently discontinued aminosalicylates or corticosteroids, these must have been stopped at minimum of 2 weeks before screening endoscopic procedure.
    9. Has been refractory to 3 biologics of ≥ 2 mechanisms of action
    10. Currently taking or has taken within 14 days prior to Day 1 any concomitant medication, herbal supplement or dietary substance (eg, grapefruit) known to be a strong inhibitor or inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), or CYP450 3A4 or is a substrate of P-gp or BCRP and has a narrow therapeutic index
    11. Taking non-UC concomitant prescription medications that have started or have had a dose adjustment within 28 days prior to Day 1. Anti-diarrheal medications and probiotics are allowed only if dose has been stable for minimum of 14 days prior to Day 1.
    12. Taking over-the-counter medications or dietary supplements started or with a dose adjustment within 14 days prior to Day 1 with the exception of up to 3 times per week use of non-steroid anti-inflammatory drugs or acetaminophen used on an as needed basis, aspirin ≤ 325 mg per day for cardiovascular prophylaxis, and over the counter doses of vitamin D
    13. Subject is positive for:
    a. Hepatitis B virus (HBV) surface antigen
    b. Hepatitis B virus core antibody (unless subject has positive hepatitis B surface antibody and undetectable serum hepatitis B DNA).
    c. Hepatitis C virus (HCV) antibody unless: a) there is evidence of undetectable viral load measured twice six months apart after successful completion of treatment regimen (reviewed by Study Medical Monitor) and b) viral load during Screening is undetectable
    d. Hepatitis E
    e. Human immunodeficiency virus (HIV) antibody
    14. Subject has had a live viral vaccine within 4 weeks prior to screening and/or is unwilling or unable to avoid live viral vaccines during the Study and for 8 weeks following completion of the Study. Subject must be willing to avoid contact with any household member who has been vaccinated with a live attenuated vaccine within 2 weeks after vaccination.
    15. Has or may have untreated active or latent TB
    16. Has any of the following:
    a. An active bacterial, parasitic, fungal, mycobacterial (including atypical infection), or viral infection, except for local skin or nail bed infection, within 2 weeks prior to Day 1.
    b. Any infection requiring intravenous antibiotics within 30 days prior to screening.
    c. Any infection requiring oral antimicrobial treatment within 2 weeks prior to screening.
    d. A history of more than two episodes of herpes zoster or one or more episodes of disseminated/complicated herpes zoster (complicated: multi-dermatomal, ophthalmic, or CNS involvement or post-herpetic neuralgia) or disseminated herpes simplex.
    e. Has had a chest radiograph or equivalent chest imaging within 3 months prior to Screening or at Screening that shows an abnormality suggestive of a malignancy of current active infection, including TB, chronic lung disease or a potentially active fungal, viral, or bacterial infection.
    f. Has C. difficile or other gastrointestinal infections (eg, Salmonella, Shigella, Yersinia, Campylobacter, E. coli 0157, etc.) on stool testing or cytomegalovirus (CMV) colitis suspected on endoscopy within 30 days of Day 1.
    17. Has ever had a bone marrow transplant.
    18. Are pregnant, lactating, breastfeeding or planning to become pregnant during the Study or within 7 days after the last dose of Study Drug
    19. Has known moderate or severe hepatic impairment (eg, Child-Pugh Class B or C)
    20. Has clinically significant abnormalities in the results of laboratory evaluations at screening
    21. Has a clinically significant abnormal electrocardiogram (ECG) at screening
    22. Has known hypersensitivity to excipients or contents of the Study drug

    Exclusion Criteria for Phase 3 Maintenance Study
    Subjects who required change of UC medications or any prohibited medication to control UC symptoms during Induction Study
    E.5 End points
    E.5.1Primary end point(s)
    Ph2b Induction Efficacy Endpoints - Change in total Mayo score from baseline at Week 8
    Ph3 Induction Efficacy Endpoints - Clinical remission by adapted Mayo score components at Week 8
    Ph3 Maintenance Efficacy Endpoints - Clinical remission by adapted Mayo score components at mWeek 44
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ph2b Induction Efficacy Endpoints - Week 8
    Ph3 Induction Efficacy Endpoints - Week 8
    Ph3 Maintenance Efficacy Endpoints - Maintenance Phase Week 44
    E.5.2Secondary end point(s)
    Ph2b Induction Efficacy Key Secondary Endpoints (with multiplicity control):
    • Clinical remission by adapted Mayo score components at Week 8

    Ph3 Induction Efficacy Key Secondary (with multiplicity control) Endpoints:
    • Endoscopic healing at Week 8
    • Symptomatic remission at Week 8
    • Clinical response by adapted Mayo score definition at Week 8
    • Mucosal healing at Week 8

    Ph3 Maintenance Efficacy Key Secondary (with multiplicity control) Endpoints:
    • Maintenance of clinical response by adapted Mayo score at mWeek 44
    • Endoscopic healing at mWeek 44
    • Symptomatic remission at mWeek 44
    • Corticosteroid-free remission at mWeek 44
    • Maintenance of clinical remission at mWeek 44 in those who were in clinical remission at mWeek 0
    • Mucosal healing at mWeek 44
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ph2b Induction Efficacy Endpoints - Week 8
    Ph3 Induction Efficacy Endpoints - Week 8
    Ph3 Maintenance Efficacy Endpoints - Maintenance Phase Week 44
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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.8.2.4Number of treatment arms in the trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Georgia
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Ukraine
    United States
    Croatia
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Slovakia
    United Kingdom
    Bulgaria
    Romania
    Spain
    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
    last subject study visit (including the 4 week follow up visit) in the Phase 3 Maintenance study.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    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: 800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 342
    F.4.2.2In the whole clinical trial 880
    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)
    Standard of care
    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 Decision2020-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-01
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