E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic contact dermatitis. Patients with nickel allergy to be specific |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056265 |
E.1.2 | Term | Allergic contact dermatitis |
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 |
To assess if there is a clinical difference in severity of ACD in participants treated with anakinra compared to placebo measured by different scoring systems for ACD. |
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E.2.2 | Secondary objectives of the trial |
To assess if there is a decrease in TRM function and inflammation after treatment with Anakinra compared to the control group, using following methods: flow cytometry, single cell RNA sequencing, immunohistochemistry, ELISA, digital spatial profiling, and qPCR. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Aged at least eighteen years old. • Able to provide written informed consent. • Have a medical diagnosis of nickel allergy with at least a +2 reaction on the ICDRG scoring system when challenged with nickel. • Fitzpatrick skin type 1-4. • Able to speak and understand Danish
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E.4 | Principal exclusion criteria |
• Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0 • Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0 • Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes. • Dermatitis and/or infection on their lower back • Recent (3 months or less) administration of a live virus vaccine. • Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating. • Taking part in any other intervention study. • Has any other condition which would, in the Investigator’s opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use). • Presence of any condition or use of any medication which precludes the use of the study drug.
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E.5 End points |
E.5.1 | Primary end point(s) |
To see a reduction in clinical score by 1 point between groups |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the second and third patch tests |
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E.5.2 | Secondary end point(s) |
To see a statistically significant reduction in total number of immune cells or cytokines between the two groups |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After the analysis of biopsies taken from third patch test |
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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 | No |
E.6.5 | Efficacy | No |
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 | 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 | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |