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Clinical Trials in the EU / 2024-514848-88-00
Authorised Phase II

BOOSTERS - BiOlogics in FOlliculitis decalvanS : an adaptaTivE tRial reSearch

2024-514848-88-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Therapeutics
Decision date
24/11/2025
Enrollment target
120
Sites
France

Condition studied

Folliculitis decalvans

Investigational medicinal product(s)

ADALIMUMABUSTEKINUMABADALIMUMABUSTEKINUMABOlumiant 4 mg film-coated tablets

Eligibility

Age group
18-64 years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-514848-88-00 on CTIS ↗ ← All trials in the EU