E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis (eczema) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
E.1.2 | Term | Atopic eczema |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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) |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of 4 weeks treatment |
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E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of 4 weeks treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 11 |