E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(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) |
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E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy at 8 weeks Safety from Day 1 until follow up PK at 2 & 8 weeks |
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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 | Yes |
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 | Yes |
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 | Yes |
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 | 4 |
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 | 5 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
United Kingdom |
United States |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |