A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia

Study Overview
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Brief Summary
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This purpose of this trial is to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial will also investigate the clinical effect of delgocitinib cream on FFA compared to a placebo cream.

Official Title
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A Phase 2a, Randomized, Double-Blind, Vehicle-Controlled, Single Site, Exploratory Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia

Conditions
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Frontal Fibrosing Alopecia

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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Inclusion criteria For Group 1 only (subjects with FFA): Male or female subject aged 18 years of age or older at the time of consent. Subject has clinically confirmed diagnosis of FFA. Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1. For Group 2 only (healthy subjects): Female subject aged 45 years of age or older at the time of consent. Female is postmenopausal. Subject is in good general health. Exclusion criteria For all subjects: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial. Presence of hepatitis B or C infection or HIV infection at screening. For Group 1 only (subjects with FFA): History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia. Subject who has undergone scalp reduction surgery or hair transplantation. Subject is known to have immune deficiency or is immunocompromised. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization. Subject has received any phototherapy within 4 weeks prior to randomization. For Group 2 only (healthy subjects): Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delgocitinib - Delgocitinib<br>Participants will be blinded and randomised to delgocitinib cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. | Drug: Delgocitinib cream<br>* Cream for topical application<br>* Other names: LEO 124249 cream;|
| Placebo Comparator: Placebo - Delgocitinib<br>Participants will be blinded and randomised to placebo cream treatment for the first 12 weeks, followed by an open label treatment with delgocitinib cream treatment for another 12 weeks. | Drug: Delgocitinib cream<br>* Cream for topical application<br>* Other names: LEO 124249 cream;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: No treatment<br>Participants will not receive any treatment. They will only provide a molecular signature of healthy skin to act as a control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expression of chemokine (C-X-C motif) ligand 9 (CXCL9), chemokine (C-X-C motif) ligand 10 (CXCL10), and interferon (IFN)-γ from baseline to Week 12. | CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent adverse events (TEAEs) from baseline to Week 12. |  | Between baseline and Week 12 |