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

NCT05332366 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EXP-2228
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this trial was 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 also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.

Conditions

Frontal Fibrosing Alopecia

Outcome Measures

Primary Outcomes (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.

  CXCL9, CXCL10 and IFN-γ are small proteins that act as chemical messengers, especially in the immune system.

  Baseline and Week 12

Secondary Outcomes (1)

• Number of Treatment-emergent Adverse Events (TEAEs) From Baseline to Week 12.

  Between baseline and Week 12

Study Arms (3)

Delgocitinib - Delgocitinib

EXPERIMENTAL

Participants were 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

Placebo - Delgocitinib

PLACEBO COMPARATOR

Participants were 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; Drug: Delgocitinib cream vehicle

No treatment

NO INTERVENTION

Participants did not receive any treatment. They only provided a molecular signature of healthy skin to act as a control.

Interventions

Delgocitinib cream DRUG

Cream for topical application

Also known as: LEO 124249 cream

Delgocitinib - Delgocitinib; Placebo - Delgocitinib

Delgocitinib cream vehicle DRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Placebo - Delgocitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

LEO Investigational Site

Burlington, Massachusetts, 01805, United States

Location

Related Publications (1)

• Martin A, Shokrian N, Kelley KJ, Correa da Rosa J, Del-Duca E, Bissonnette R, Sorensen OE, Nielsen AB, Guttman-Yassky E, Senna MM. Randomized Controlled Trial of the Topical Jak Inhibitor Delgocitinib Cream in Patients with Frontal Fibrosing Alopecia. J Invest Dermatol. 2025 Oct 14:S0022-202X(25)03406-2. doi: 10.1016/j.jid.2025.09.375. Online ahead of print.

  PMID: 41101628 DERIVED

Results Point of Contact

• Title: Clinical Disclosure
• Organization: Leo Pharma

disclosure@leo-pharma.com

+4544945888

Study Officials

• Translational Medical Leader

  LEO Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 19, 2022
• Primary Completion: February 13, 2023
• Study Completion: May 22, 2023
• Last Updated: March 6, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)