Clinical Trial to Evaluate UV-light-induced Allergic Skin Reactions After Application of Delgocitinib Cream

Study Overview
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Brief Summary
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Participants will have study medicine applied by site staff- delgocitinib cream or vehicle, and then exposed to UV light. The trial is designed to find out if delgocitinib cream can cause skin photoallergy after UV-light exposure in people with healthy skin.

Detailed Description
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This is a single-centre, randomised, double-blind, vehicle-controlled, within-subject comparison phase 1 trial in Germany. The trial consists of a screening phase, an induction phase, a rest phase, and a challenge phase. There will be 2 columns of test fields on each participant's back with the 3 treatments in either column for a total of 6 treatments. One column of test fields will be irradiated and the other will not be irradiated. All participants will be exposed to UV-light on skin treated delgocitinib cream or vehicle and on untreated skin on test fields to be irradiated.

Official Title
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A Phase 1 Clinical Trial to Evaluate the Photoallergic Potential of Delgocitinib Cream 20 mg/g After Topical Occlusive Application in Subjects With Healthy Skin

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Delgocitinib cream
* Drug: Delgocitinib cream vehicle


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy subjects aged 18-64 years (inclusive). Fitzpatrick skin type of I, II, or III. Exclusion Criteria: Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes, or dense body hair in the range of the test fields. Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction. Any history of or presence of cancerous or precancerous skin lesions in general including melanoma, lentigo maligna, basal cell carcinoma, dysplastic naevi or actinic keratoses. History of or active or both photo-induced or photo-aggravated disease (e.g. cutaneous or lupus erythematodes, polymorphic light eruptions). Use of any topical or systemic medication that could interfere with the trial objective within 2 weeks before randomisation until subject's end of trial. Use of drugs that might cause photosensitising or phototoxic reactions within 4 weeks before randomisation until subject's end of trial. Foreseeable intensive UV-light exposure to test fields within 4 weeks before randomisation until subject's end of trial (solar or artificial).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive all treatments with treatments randomised over test fields.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delgocitinib cream 20 mg/g<br>topical occlusive administration | Drug: Delgocitinib cream<br>* Cream for topical application<br>* Other names: LEO 124249 cream;|
| Placebo Comparator: Delgocitinib cream vehicle<br>topical occlusive administration | Drug: Delgocitinib cream vehicle<br>* The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.<br>|
| No Intervention: Untreated skin<br>topical occlusive administration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive skin reaction at 72 hours after irradiation | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The evaluation of skin reaction at the end of the challenge phase performed using the following scale: 0 negative 1 equivocal 2 positive. A positive score indicates presence of a UV-light-induced allergic skin reaction. | Up to 72 hours after irradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events from baseline to 14 days after subject's end of trial | Treatment-emergent adverse event | From baseline to 14 days after subject's end of trial (Day 5 of challenge phase, or if applicable Day 5 of re-challenge phase. | 
| Skin reaction score after irradiation during induction phase | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: 0 No reaction 1 Erythema 2 Erythema with dermal infiltrate 3 Erythema with papulovesicles 4 Erythema with blisters, erosions | up to Day 22 | 
| Skin reaction score after irradiation during the challenge phase (up to Day 40, Week 6). | A reaction is considered positive if the skin reaction score for the irradiated test field is at least 1 point higher than both the non-irradiated test field exposed to the same strength of IMP, and the irradiated control field. The grading for the skin reaction score will be performed according to the following 5-point scale: 0 No reaction 1 Erythema 2 Erythema with dermal infiltrate 3 Erythema with papulovesicles 4 Erythema with blisters, erosions | up to Day 40 |