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

• ClinicalTrials.gov Identifier: NCT05332366
• Recruitment Status: Active, not recruiting
• First Posted: April 18, 2022
• Last Update Posted: December 9, 2022
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Frontal Fibrosing Alopecia	Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: April 19, 2022
• Estimated Primary Completion Date: March 9, 2023
• Estimated Study Completion Date: June 15, 2023

Arms and Interventions

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 Name: 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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: Baseline and Week 12 ]
   CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Massachusetts

LEO Investigational Site

Burlington, Massachusetts, United States, 01805

Sponsors and Collaborators

LEO Pharma

Investigators

• Study Director: Translational Medical Leader; LEO Pharma

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT05332366
• Other Study ID Numbers: EXP-2228
• First Posted: April 18, 2022
• Last Update Posted: December 9, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
• URL: http://leopharmatrials.com/for-professionals

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical