ADALIMUMAB for Folliculitis decalvans

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18-year-old and < 65-year-old\n- 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\n- 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.\n- 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))\n- Normal chest x-ray less than 3 months old on the day of inclusion\n- Individuals affiliated to a social security regimen\n- Individuals able to understand and express himself/herself in French\n- Individuals able to participate and to follow up during the study period\n- Written informed consent from the patient\n- Patient is up to date with their vaccinations, and vaccinations against influenza, COVID-19, and pneumococcus are recommended"}

Exclusion criteria

• {"criterion_text":"- Patients with a history of cardiac ischaemia\n- 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.\n- Morbid obesity: BMI > 40\n- Individuals with known positive HIV tests and any immunosuppressive condition or drugs\n- Hypersensitivity to the active substance or to any of the excipients: Adalimumab, Ustekinumab, Baricitinib (see SmPC)\n- Patient who has already received one of the treatments evaluated (Adalimumab, Ustekinumab, Baricitinib)\n- Patient with renal insufficiency (creatinine clearance < 60 mL/min)\n- Coexisting inflammatory facial dermatosis such as acne fulminans, hidradenitis suppurativa\n- Active tuberculosis or other severe infections such as sepsis and opportunistic infections\n- 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\n- Individuals under a measure of legal protection or unable to consent\n- 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"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is an IGA score (FD-IGA) which will be assessed by a blinded assessor. Success will be defined by at least a decrease of 2 points of the FD-IGA at 6 months.","definition_or_measurement_approach":"Assessed by a blinded assessor; success defined as at least a 2-point decrease in FD-IGA score at 6 months."}

Secondary endpoints

• {"endpoint_text":"- Pain evaluated by Visual Analogue Scale (VAS) at randomization, 3, 6 and 12 months. Pain change from randomization, at 3, 6 and 12 months.","definition_or_measurement_approach":"Pain measured by VAS at randomization and at 3, 6, 12 months; analysis of change from baseline at those timepoints."}
• {"endpoint_text":"- Pruritus evaluated by WI-NRS (Worst Itch Numeric Rating Scale) at randomization, 3, 6 and 12 months","definition_or_measurement_approach":"WI-NRS measured at randomization and at 3, 6, 12 months to assess pruritus severity and change from baseline."}
• {"endpoint_text":"- Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months","definition_or_measurement_approach":"DLQI administered at randomization and at 3, 6, 12 months to measure change in dermatology-specific quality of life."}
• {"endpoint_text":"- Time to first relapse during the study period","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomization to first relapse during study follow-up."}
• {"endpoint_text":"- Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue)","definition_or_measurement_approach":"FD-IGA score measured at the start of antibiotic rescue therapy for that subgroup of patients."}
• {"endpoint_text":"- Measure of FD-IGA score (blinded assessor) at 12 months","definition_or_measurement_approach":"FD-IGA assessed by a blinded assessor at 12 months to evaluate longer-term outcome."}
• {"endpoint_text":"- Tolerance of drugs","definition_or_measurement_approach":"Assessment of drug tolerability/adverse events (safety/tolerability endpoints) during treatment and follow-up."}

Methods

• Posters at AP-HP (Assistance Publique Hôpitaux de Paris) sites (document: K1_ Poster for AP-HP sites)
• Posters at non-AP-HP sites (document: K1_ Poster for non-AP-HP sites)
• Text for radio, press, newspapers and social networks (document: K1_Text for radio press newspapers social networks)
• Patient-facing documents and patient card (documents: D4_Patient facing documents Poster..., Patient card, diaries)

France

Earliest CTIS Part Ii Submission Date

29-10-2025

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

195

Number Of Sites

21

Number Of Participants

120

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France