E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe erythematotelangiectactic rosacea (ETR) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039218 |
E.1.2 | Term | Rosacea |
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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 |
To evaluate the efficacy of CD08514 40 mg and 10 mg BID (i.e. respectively 80 mg and 20 mg per day) over 8 weeks of treatment, in a double blind placebo-controlled study, in subjects presenting with moderate to severe erythematotelangiectatic rosacea (ETR). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety profile of CD08514 40 mg and 10 mg BID (i.e. respectively 80 mg and 20 mg per day) over 8 weeks of treatment, in a double blind placebo-controlled study, in subjects presenting with moderate to severe ETR. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject is a male or female adult aged 18 to 65.
- Subject presenting with moderate to severe ETR characterized by:
* A persistent erythema on the face,
* An erythema severity score graded at least 3 on a 5-point scale (from 0 to 4), on each cheek,
* No history of inflammatory (papules and/or pustules) lesions during the past 3 months before Baseline. However, subject with a few papules and/or pustules on non-analysed areas could be included.
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E.4 | Principal exclusion criteria |
- The subject has a particular form of rosacea or rosacea like syndrome (papulopustular rosacea, rhinophyma, severe forms: rosacea conglobata or fulminans), corticosteroids-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (known carcinoid syndrome, dysthyroidism, mastocytose, serotonin syndrome, lupus erythematosis …) or with peri-oral dermatitis.
- The subject has an underlying disease, surgical or medical condition, which:
* could interfere with evaluations of the rosacea condition itself (e.g., atopic dermatitis, eczema or acne vulgaris); * could put the subject at risk (uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS…).
- The subject has a past history of gastric or duodenal ulcer, gastrooesophageal reflux disease (GERD), oesophagitis or pathological hypersecretory conditions or a Zollinger-Ellison syndrome or recurrent gastralgies.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in cheek-combined erythema severity score (total sum score of the 2 cheeks) on Day 54 |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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.8.3 |
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 | 4 |
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 | Information not present in EudraCT |
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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Provided in the protocol in section 4.1 |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |