Evaluation of Ustekinumab, Adalimumab, and Baricitinib in Patients with Refractory Folliculitis Decalvans: An Adaptive Immunomodulatory Trial
- Trial ID
- 2024-514848-88-00
- Protocol
- APHP230831
Trial statistics
Objectives
The primary objective of this study is to identify effective immunomodulatory targeted therapies in patients with difficult-to-treat folliculitis decalvans. Success is defined as a minimum of 30% of patients achieving a reduction of at least 2 points in the folliculitis decalvans investigator global assessment (FD-IGA) score, as determined by a blinded assessor, at 6 months. Secondary objectives include the evaluation of:
- Improvement in pain and pruritus;
- Changes in quality of life;
- Time to relapse;
- FD-IGA scores in patients requiring antibiotic rescue therapy;
- FD-IGA scores at 12 months;
- Safety and tolerance of the administered drugs.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients between the ages of 18 and 65 years diagnosed with folliculitis decalvans. Inclusion requires a diagnosis confirmed by histopathology and validation by an expert. Participants must present with a baseline folliculitis decalvans investigator global assessment score of 3 or 4. The population includes individuals who have undergone at least two lines of antibiotic therapy within the previous two years. Additionally, subjects must have a normal chest x-ray obtained within three months of inclusion.
Plans and Procedures
This phase II adaptive trial is designed to evaluate the efficacy of immunomodulatory targeted drugs in patients with folliculitis decalvans. The primary objective is to identify successful treatments defined by a decrease of at least 2 points in the Investigator Global Assessment (FD-IGA) score, as assessed by a blinded assessor, at 6 months. The study investigates the use of ustekinumab, adalimumab, and baricitinib. Secondary endpoints include the assessment of pain via the Visual Analogue Scale, pruritus using the Worst Itch Numeric Rating Scale, and quality of life through the Dermatology Life Quality Index at various intervals, including randomization, 3, 6, and 12 months. The research also monitors the time to first relapse, the impact of antibiotic rescue, and the tolerance of the administered drugs. The study duration is estimated to occur between December 2025 and December 2029.
Treatment
Ustekinumab is administered via subcutaneous injection at a dosage of 90 mg.
Adalimumab is administered via subcutaneous injection at a dosage of 160 mg.
Baricitinib is provided in the form of film-coated tablets for oral administration at a dosage of 4 mg.
Efficacy
The primary efficacy endpoint is the Folliculitis decalvans Investigator Global Assessment (FD-IGA) score, which is evaluated by a blinded assessor. Clinical success is defined as a reduction of at least 2 points in the FD-IGA score at 6 months.
Secondary efficacy parameters include:
- Pain, assessed using the Visual Analogue Scale (VAS) at randomization, 3, 6, and 12 months, including the change from randomization at these timepoints.
- Pruritus, evaluated via the Worst Itch Numeric Rating Scale (WI-NRS) at randomization, 3, 6, and 12 months.
- Quality of life, measured by the Dermatology Life Quality Index (DLQI) at randomization, 3, 6, and 12 months.
- Time to first relapse during the study period.
- FD-IGA scores at 12 months and at the onset of antibiotic rescue.
- Tolerance of the investigational drugs.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patients ≥ 18-year-old and < 65-year-old
- Presenting with FD confirmed* in all cases by at least one compatible histopathology (present or past). *The diagnosis of Folliculitis Decalvans must have been validated collectively as part of care with at least one FD expert.
- All patients should have a basal FD-IGA score at 3 or 4 and should have received in the previous 2 years at least two lines of antibiotics (first line : at least 3 months doxycycline/lymecycline (doxycycline 200 mg/day for at least 2 weeks, then 100 mg/day in the following weeks, or lymecycline 300 mg/day for at least 2 weeks, then 150 mg/day in the following weeks); second line : and Rifampicinrifampicin/clindamycin 10 weeks (classic regimen for FD) or, in case of contraindication or unavailability of one or both of these drugs, other antibiotics prescribed for at least 3 weeks alone or in combination (list of antibiotics in Addendum 18.4))
- Normal chest x-ray less than 3 months old on the day of inclusion
- Individuals affiliated to a social security regimen
- Individuals able to understand and express himself/herself in French
- Individuals able to participate and to follow up during the study period
- Written informed consent from the patient
- Patient is up to date with their vaccinations, and vaccinations against influenza, COVID-19, and pneumococcus are recommended
- Participants must not have received a live vaccine within 28 days prior to the first dose of the investigational medicinal product (IMP) and must have no planned requirement for live vaccination during the study period. Administration of inactivated vaccines is permitted
Exclusion Criteria
- Patients with a history of cardiac ischaemia
- Moderate to severe heart failure (NYHA classes III/IV) As the whole treatment duration will only be 6 months, the risk of baricitinib-related SAEs will be minimized according to the recent PRAC from the EMA by excluding: Patients at increased risk of major cardio-vascular problem, Patients heavy smokers (25 cig/day), Current or past history of malignancy, with the exception of non-melanoma skin cancer excised and cured more than five years before baseline, per investigator assessment.
- Morbid obesity: BMI > 40
- Individuals with known positive HIV tests and any immunosuppressive condition or drugs
- Hypersensitivity to the active substance or to any of the excipients: Adalimumab, Ustekinumab, Baricitinib (see SmPC)
- Patient who has already received one of the treatments evaluated (Adalimumab, Ustekinumab, Baricitinib)
- Patient with renal insufficiency (creatinine clearance < 60 mL/min)
- Coexisting inflammatory facial dermatosis such as acne fulminans, hidradenitis suppurativa
- Active tuberculosis or other severe infections such as sepsis and opportunistic infections
- Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures
- Individuals under a measure of legal protection or unable to consent
- Participation in another interventional study involving human participants or in the exclusion period at the end of a previous study involving human participants, if applicable
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Yet Recruiting | 01 Dec 2025 | 120 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
ADALIMUMAB | Test | — | SUBCUTANEOUS INJECTION | 160 | 6 | SUB20016 |
USTEKINUMAB | Test | PHF00230MIG | SUBCUTANEOUS INJECTION | 90 | 6 | SCP125835168 |
ADALIMUMAB | Test | PHF00231MIG | SUBCUTANEOUS INJECTION | 160 | 6 | SCP172034 |
USTEKINUMAB | Test | — | SUBCUTANEOUS USE | 90 | 6 | SUB27761 |
Olumiant 4 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL | 4 | 6 | PRD4760225 |