E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male or female patients with a clinical diagnosis of either Discoid Lupus Erythematosus or Systemic Lupus Erythematosus and at least one newly developed, sharply demarcated DLE lesion. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025138 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to compare the treatment effect of ASF-1096 Cream 0.5% to ASF-1096 Cream Placebo on a newly developed DLE lesion after 8 weeks of twice daily, topical treatment. |
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E.2.2 | Secondary objectives of the trial |
To compare the treatment effect of ASF-1096 Cream 0.5% to ASF-1096 Cream placebo with regard to the response/rating on/of:
• Erythema • Scaling/hypertrophy • Dyspigmentation • Scarring/Atrophy/Panniculitis • Induration • Pain • Itching • Lesion area • General improvement assessed by the investigator • Global improvement assessed by the patient after 2, 4, 6 and 8 weeks of treatment. • To compare and describe the safety profile in the ASF-1096 Cream 0.5 % and ASF-1096 Cream placebo groups. Additionally, plasma concentration of R-Salbutamol will be measured at week 2 and 8. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All of the following criteria have to be met for inclusion of a patient in the study: • Patients of any gender aged from 18 to 70 years; • A clinical diagnosis of either DLE or SLE; • At least one newly developed, sharply demarcated DLE lesion (target lesion) with erythema score >1 and scaling score >1; • Histological results from biopsy confirming the diagnosis will be obtained at the beginning of the study, in case histological results confirming the diagnosis are available a new biopsy is not needed; • The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study; systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; • Willing and able to comply to the study procedures; • Prepared to grant authorised persons access to the medical records; • Signed informed consent. |
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E.4 | Principal exclusion criteria |
Patients will not be included in the study when one or more of the following conditions are met: • Active skin disease other then DLE or another progressive or serious disease that interferes with the study outcome; • Scarring at the traget lesion; • Keratonisation of treated lesion; • Concomitant, or within four weeks prior to dosing, treatment with corticosteroids (local or systemic), anti-malarials, retinoids or thalidomide; • Systemic treatment of SLE; • Concomitant, or within four weeks prior to dosing, treatment with medicinal products containing salbutamol (local or systemic); • Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • Participation in another clinical trial, including the four week period preceding the study; • Known allergic reactions to components of the study preparations; • Pregnancy (according to pregnancy test) or nursing. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint for this study is the efficacy of ASF-1096 Cream 0.5% compared to the ASF-1096 Cream Placebo using the area under the curve (AUC) of the local CLASI score.
For analysis of the primary endpoint the null-hypothesis. H0: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 Cream 0.5% and the ASF-1096 Cream Placebo are the same. H1: The mean AUCs of the local CLASI score in the groups treated with ASF-1096 Cream 0.5 % and the ASF-1096 Cream placebo are not the same. |
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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 | No |
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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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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The end of the trial is the last visit of the last subject undergoing the trial. In the case of premature termination for any reason by a patient, the patient will be asked to do the End of Trial visit. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |