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    Summary
    EudraCT Number:2012-005389-36
    Sponsor's Protocol Code Number:CT327-2005
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-19
    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 number2012-005389-36
    A.3Full title of the trial
    A phase II randomised, double blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of CT327 topical ointment (0.05% and 0.5% w/w) compared to vehicle, in subjects with mild or moderate atopic dermatitis with at least moderate pruritus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety and tolerability of CT327 ointment in subjects with mild/moderate atopic dermatitis
    A.3.2Name or abbreviated title of the trial where available
    CT327 Phase IIb Atopic Dermatitis Study
    A.4.1Sponsor's protocol code numberCT327-2005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01808157
    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 SponsorCreabilis Limited
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCT327
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCT327
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05 to %
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCT327
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5 to %
    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 placeboOintment
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis (eczema)
    E.1.1.1Medical condition in easily understood language
    Eczema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objectives of the study are: • To determine whether CT327 is effective in reducing pruritus (itch) in subjects with atopic dermatitis, using a pruritus visual analogue scale (VAS) • To assess the efficacy of CT327 on atopic dermatitis using the Investigator Global Assessment (IGA)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are: • To determine CT327 efficacy using the Eczema Area and Severity Index (EASI) • To determine whether CT327 is effective in reducing pruritus in subjects with atopic dermatitis, using the modified 5-D pruritus scale (5-D) • To evaluate the efficacy of CT327 on pruritus using the Severity of Pruritus Score (SPS) • To determine whether CT327 is efficacious in reducing body surface area affected by atopic dermatitis • To determine the safety and toleration of CT327 in subjects with atopic dermatitis, including application site toleration • To determine the plasma levels of CT327, following topical application • To obtain an initial evaluation of the efficacy, safety and toleration of CT327 in an adolescent atopic dermatitis population The exploratory objectives are • To explore the time to onset of CT327 in reducing pruritus in subjects with atopic dermatitis using the daily pruritus visual analogue scale scores collecte
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent signed and dated by the subject or the subject’s parent/legal guardian, with assent from the subject, if appropriate. 2. Male and female subjects aged ≥ 12 years. 3. Clinical diagnosis of atopic dermatitis (as defined by Hanifin and Rajka criteria) with: • IGA score of 2 or 3 (mild or moderate) • Score of ≥ 40mm on all screening pruritus VAS assessments (average and worst over the last 24 hours and current itch) • A minimum of 5% and not more than 20% of the subjects’ BSA affected by atopic dermatitis (affected is defined as active atopic dermatitis lesions or pruritus) • Amenable to treatment with topical treatment • Stable disease for ≥1 months prior to screening 4. The subject and/or the subject’s legal guardian must be willing and able to comply with the study instructions (Section 4.5), apply the study medication as directed and attend all scheduled visits. 5. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and before the start of study treatment. 6. Any subject who is sexually active must agree to use an effective contraceptive method throughout the study.
    E.4Principal exclusion criteria
    1. Atopic dermatitis only affecting the head or scalp. 2. Unstable or actively infected atopic dermatitis. 3. Concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug. 4. Subjects who have received monoclonal antibody therapy for their atopic dermatitis in the 4 months prior to screening. 5. Subjects who have used systemic immunosuppressive drugs, corticosteroids or received PUVA therapy in the 4 weeks prior to starting study treatment, or are scheduled to start these treatments during the study period. 6. Subjects who have used topical immunomodulators (pimecrolimus, tacrolimus) within 2 weeks of starting study treatment or are scheduled to start these treatments during the study period. 7. Subjects who have used topical corticosteroids from WHO group II, III or IV, or other treatments for atopic dermatitis, including wet wraps, within 2 weeks prior to starting study treatment or are likely to require treatment with these medications during the study period. 8. Subjects who are unable to abstain from using emollients from baseline (Visit 2) until the end of study treatment (Visit 6). 9. Subjects who are using any concomitant medication(s) that, in the investigators’ opinion, could affect the subject’s atopic dermatitis or pruritus (for example TADs, SSRI, pregabalin). Subjects using such medications may be included, at the investigators discretion, if they have been stable on treatment for at least 1 month prior to the start of study treatment and no changes to these medications are planned during the study period. 10. Subjects undergoing, or due to have, UVA, or UVB therapy in the 2 weeks prior to starting study treatment or during the study period. 11. Planned exposure of affected areas to excessive sunlight. 12. Subjects who have used fake tanning products in the 2 weeks prior to screening or those who are intending to use these products during the study period. 13. Female subjects who are pregnant and lactating mothers. 14. Subjects with a clinically significant abnormal laboratory safety test and/or 12-lead ECG results at screening. 15. Subjects who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment. 16. Subjects with a known reaction or allergy to test drug or excipients. 17. Subjects who in the opinion of the investigator, have any acute chronic medical or psychiatric condition which would make them unsuitable for participation in this study or which places the subject at undue risk (e.g. history of drug, alcohol or other substance abuse) or other factors limiting the ability of the subject to co-operate and to comply with this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome for the study is change from baseline in the pruritus visual analogue scale score assessing average itch over the previous 24 hours and controlled disease: Binary response defined as a score of “clear” (0) or “almost clear” (1) on the Investigator Global Assessment or a minimum improvement of 2 categories from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of 4 weeks treatment
    E.5.2Secondary end point(s)
    The secondary endpoints are: - To determine CT327 efficacy using the Eczema Area and Severity Index (EASI) - To determine whether CT327 is effective in reducing pruritus in subjects with atopic dermatitis, using the modified 5-D pruritus scale (5-D) - To evaluate the efficacy of CT327 on pruritus using the Severity of Pruritus Score (SPS) - To determine whether CT327 is efficacious in reducing body surface area affected by atopic dermatitis - To determine the safety and toleration of CT327 in subjects with atopic dermatitis, including application site toleration - To determine the plasma levels of CT327, following topical application - To obtain an initial evaluation of the efficacy, safety and toleration of CT327 in an adolescent atopic dermatitis population - To explore the time to onset of CT327 in reducing pruritus in subjects with atopic dermatitis using the daily pruritus visual analogue scale scores collected every 12 hours, immediately prior to dosing on Days 2-29 - To explore the CT327 efficacy on night and day time itch in subjects with atopic dermatitis using the daily pruritus visual analogue scale scores collected every 12 hours, immediately prior to dosing on Days 2-29
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of 4 weeks treatment
    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 No
    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 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.8.2.4Number of treatment arms in the trial3
    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 concerned15
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 63
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 63
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 147
    F.1.3Elderly (>=65 years) No
    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 state210
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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)
    Subjects will have a final study visit 2 weeks after the last application of study medication. If required, subjects may begin other atopic dermatitis/emollients during this period. Any SAE occuring up to 28 days after the last dose of study medication will be captured. Subjects will be asked to contact the site and report any SAEs that occur in the 2 weeks after the follow up visit. CT327 is an IMP and not …..
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Primary Care Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-30
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