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

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

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.

Study Overview

• Status: Completed
• Conditions: Frontal Fibrosing Alopecia
• Intervention / Treatment: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • LEO Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

For Group 1 only (subjects with FFA):

1. Male or female subject aged 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of FFA.
3. 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):

1. Female subject aged 45 years of age or older at the time of consent.
2. Female is postmenopausal.
3. Subject is in good general health.

Exclusion criteria

For all subjects:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
2. Presence of hepatitis B or C infection or HIV infection at screening.

For Group 1 only (subjects with FFA):

1. History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
2. Subject who has undergone scalp reduction surgery or hair transplantation.
3. Subject is known to have immune deficiency or is immunocompromised.
4. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.
5. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.
6. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.
7. Subject has received any phototherapy within 4 weeks prior to randomization.

For Group 2 only (healthy subjects):

1. 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.
2. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delgocitinib - Delgocitinib; 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; Cream for topical application; Other Names: LEO 124249 cream
Placebo Comparator: Placebo - Delgocitinib; 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; Cream for topical application; Other Names: LEO 124249 cream; Drug: Delgocitinib cream vehicle; The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
No Intervention: No treatment; 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?

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Study Director: Translational Medical Leader, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: EXP-2228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No