BOOSTERS - BiOlogics in FOlliculitis decalvanS : an adaptaTivE tRial reSearch

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-11-24

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-514848-88-00

ClinicalTrials.gov

NCT07268534

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To select immunomodulatory targeted drugs in difficult-to-treat patients with at least 30% of success defined by a decrease of 2 points at least of the FD-IGA score (blinded assessor) at 6 months.

Secondary objectives 7

1. To assess the improvement of pain
2. To assess the improvement of pruritus
3. To assess the improvement of quality of life
4. To assess the time to first relapse
5. To assess FD-IGA score in patients receiving the antibiotic rescue
6. To assess FD-IGA score at 12 months
7. To assess tolerance of drugs

Conditions and MedDRA coding

Folliculitis decalvans

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Patients ≥ 18-year-old and < 65-year-old
2. 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.
3. 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))
4. Normal chest x-ray less than 3 months old on the day of inclusion
5. Individuals affiliated to a social security regimen
6. Individuals able to understand and express himself/herself in French
7. Individuals able to participate and to follow up during the study period
8. Written informed consent from the patient
9. Patient is up to date with their vaccinations, and vaccinations against influenza, COVID-19, and pneumococcus are recommended
10. 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 12

1. Patients with a history of cardiac ischaemia
2. 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.
3. Morbid obesity: BMI > 40
4. Individuals with known positive HIV tests and any immunosuppressive condition or drugs
5. Hypersensitivity to the active substance or to any of the excipients: Adalimumab, Ustekinumab, Baricitinib (see SmPC)
6. Patient who has already received one of the treatments evaluated (Adalimumab, Ustekinumab, Baricitinib)
7. Patient with renal insufficiency (creatinine clearance < 60 mL/min)
8. Coexisting inflammatory facial dermatosis such as acne fulminans, hidradenitis suppurativa
9. Active tuberculosis or other severe infections such as sepsis and opportunistic infections
10. 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
11. Individuals under a measure of legal protection or unable to consent
12. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. Pain evaluated by Visual Analogue Scale (VAS) at randomization, 3, 6 and 12 months. Pain change from randomization, at 3, 6 and 12 months.
2. Pruritus evaluated by WI-NRS (Worst Itch Numeric Rating Scale) at randomization, 3, 6 and 12 months
3. Quality of life evaluated by Dermatology life quality index (DLQI) at randomization, 3, 6 and 12 months
4. Time to first relapse during the study period
5. Measure of FD-IGA score in the population of patients receiving the antibiotic rescue (at the onset of the rescue)
6. Measure of FD-IGA score (blinded assessor) at 12 months
7. Tolerance of drugs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Bruno Matard (Coordinating investigator)

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Bruno Matard (Coordinating investigator)

Locations

1 EU/EEA country · 21 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications