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    Summary
    EudraCT Number:2011-004640-21
    Sponsor's Protocol Code Number:CT327-2003
    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:2012-02-02
    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 number2011-004640-21
    A.3Full title of the trial
    A Randomized, Placebo-controlled Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w topical CT327 when Applied Twice Daily in Subjects with Psoriasis Vulgaris.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CT327 Psoriasis Study
    A.3.2Name or abbreviated title of the trial where available
    CT327 Phase IIb Psoriasis Study
    A.4.1Sponsor's protocol code numberCT327-2003
    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 organisationCreabilis Limited
    B.5.2Functional name of contact pointJulia Hamlin
    B.5.3 Address:
    B.5.3.1Street Address6 Denne Hill Business Centre
    B.5.3.2Town/ cityWomenswold, Canterbury
    B.5.3.3Post codeCT4 6HD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01227833425
    B.5.6E-mailjhamlin@creabilis-sa.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 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
    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 number0.1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCT327
    D.3.9.4EV Substance CodeAS3
    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
    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
    Psoriasis Vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal objective of the study is to determine the efficacy of three strengths of CT327 ointment (0.05%, 0.1% and 0.5%) compared to placebo ointment, when applied twice daily to psoriasis vulgaris lesions for up to 8 weeks.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to collect data on the safety and toleration of CT327 ointment in this patient population and to look at levels of CT327 that get into the blood, following application to the skin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects aged >18 years. 2. Willing and able to give written informed consent. 3. Diagnosis of stable psoriasis vulgaris (PV) 4. IGA score of at least mild 5. A minimum mPASI score of 2 in at least one body region i.e. psoriasis affecting up to 10% of arms, and/or 10% of trunk, and/or 10% of legs PV affecting up to 10% of the subject's body surface area (excluding the face and scalp). 6. Amenable to treatment with topical treatment. 7. At least one target plaque with a plaque elevation of at least moderate severity (grade ≥3 on mPASI severity scale). 8. Subjects who are willing to avoid exposure to sun, UVA, or UVB from screening until the end of the study. 9. Subjects who are willing and able to comply with the study instructions, apply the study medication as directed and attend all scheduled visits. 10. Females of child-bearing potential must have a negative urine pregnancy test before randomization and must agree to use an adequate contraception during the study.
    E.4Principal exclusion criteria
    1. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 2. Subjects with psoriasis that includes the groin, axillae, and other intertriginous areas. 3. Subjects taking concomitant dermatologic treatments or with concomitant medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug. 4. Subjects with a clinical diagnosis of bacterial infection of the skin including impetigo and abscesses. 5. Subjects undergoing systemic anti-psoriatic treatment or PUVA therapy within 4 weeks prior to visit 1 or planned treatment during the study. 6. Subjects receiving UVB therapy within the 2 weeks prior to visit 1 or planning to receive it during the study. 7. Subjects who have received monoclonal antibody therapy in the 4 months prior to screening. 8. Subjects using topical psoriatic treatments including corticosteroids, retinoids and vitamin D derivatives in the two weeks prior to visit 1 or who would require treatment with these agents during the study. The use of an emollient or topical salicylic acid derivative for facial or scalp lesions is allowed. 9. Subjects taking or scheduled to start non antipsoriatic concomitant medication that could affect psoriasis (e.g. immunosuppressants, beta blockers, lithium) during the study. 10. Female subjects who are pregnant or lactating, or intend to become pregnant during the study or within a month of study completion. 11. Subjects who have any clinically significant abnormal clinical laboratory test results at screening. 12. Subjects who have received any investigational drug or taken part in any clinical study within three months prior to the study start. 13. Subjects with a known reaction or allergy to the test drug or excipients. 14. Any subjects with major medical illness or symptoms of a clinically significant illness that may influence the study outcome. 15. Obese subjects should be excluded if the opinion of the investigator the condition is likely to impact the assessment of their psoriasis and impede their ability to apply the study medication. 16. Subjects who in the opinion of the investigator, have any acute chronic medical or psychiatric condition or laboratory abnormality 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 is controlled disease, defined as a score of none or minimal using the Investigator Global Assessment (IGA) and improvement of 2 categories from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All subjects will be assessed following 8 weeks of treatment. Although subjects can discontinue after 4 weeks treatment in the event of a complete response (page 15 of study protocol - 3.1 Study design)
    E.5.2Secondary end point(s)
    • mPASI-75: Binary response defined as a reduction of ≥75% from baseline on the mPASI • Clinical success at the target lesion: Binary response defined as ‘clear’ or ‘almost clear’ for all of the three psoriatic signs on the target lesion • mPASI-50: Binary response defined as a reduction of ≥50% from baseline on the mPASI • Change from baseline in the mPASI score • Change from baseline in target lesion total severity score • Change from baseline in pruritus visual analogue scale (VAS) score, in subjects with at least moderate psoriasis-related pruritus at baseline • Body surface area affected by psoriasis • CT327 and CT340r concentrations in blood and urine • Adverse events (including local site reactions), blood pressure, pulse, electrocardiogram (ECG), laboratory variables and physical examination
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy at 8 weeks Safety from Day 1 until follow up PK at 2 & 8 weeks
    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 No
    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
    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 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 No
    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
    United Kingdom
    United States
    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 (follow up visit)
    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 months6
    E.8.9.1In the Member State concerned days0
    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 days0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 160
    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 be followed up 4 weeks (21 days) after the last application of study medication. If required, subjects may begin commercial psoriasis treatment during this follow up period, but those subjects who start treatments in the 4-week follow up period will not have their disease assessed at the follow up visit. Those who do not require treatment in the follow up period will be assessed to monitor the change in disease severity off treatment.
    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 Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-17
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