Informations générales (source: ClinicalTrials.gov)
A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients Versus Tetracycline Derivative
Interventional
Phase 3
Institut Pasteur (Voir sur ClinicalTrials)
mai 2025
février 2028
09 mai 2026
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active
Hidradenitis Suppurativa patients versus tetracycline derivative
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CDS DE L INSTITUT PASTEUR | Maïa Delage-Toriel, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Rouen - Rouen - France | Anne-Bénédicte Duval-Modeste, Dr | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - Marseille - France | Marie-Aleth Richard, MD, PhD | Contact (sur clinicalTrials) | |||
| Hopital St Joseph - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Adults < 60 years old
- Diagnosis of HS according to European Dermatology guidelines:
- Recurrent inflammation occurring more than 2 times in the past 6 months in the
inverse regions of the body, presenting with nodules, sinus-tracts and/or
scarring.
- Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and
infra-mammary areafor women). Presence of nodules (inflamed or noninflamed),
sinus tracts (inflamed or noninflamed), abscesses, scarring (atrophic,
mesh-like, red, hypertrophic or linear)
- Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year
- Clinical severity of HS at inclusion: Hurley stage 2
- BMI < 35
- Written informed consent from patient
- Patient able to complete DLQI
- Patients affiliated to the French health system (Assurance Maladie), except French
state medical aid beneficiaries (Aide Médicale d'Etat)
- Active compatible contraception for men and women of childbearing or inability to
procreate
- Available laboratory blood test performed within the last 2-months
Non inclusion Criteria:
- Person < 18 and ≥ 60 years old
- Former stage 3 HS
- Previous use of the experimental treatment
- Unauthorized drugs for the study during the month preceding the inclusion
- Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch,
riboflavin notably):
pregnancy, breastfeeding, known allergy to experimental or reference drugs, wheat
allergy, tendinopathy, QT prolongation, bradycardia, heart failure, heart rhythm
disturbances, hydroelectrolytic disorders, hypokalemia, coagulation disorders, severe
liver/kidney dysfunction, porphyria, mandatory use of nonsteroidal anti-inflammatory
drugs (NSAIDs) for other medical conditions
- Unbalanced diabetes (ie HbA1c above 7%)
- Dysphagia, untreated gastro-oesophageal reflux/ulcer
- BMI ≥ 35
- Immune suppression, inflammatory disease, including gastroenterologic and
rheumatologic inflammatory conditions
- Lactase deficiency, lactose and galactose intolerance
- Malabsorption syndrome
- Person living in the same household as another patient
- Person under guardianship or curatorship
- Individuals with any condition which, in the opinion of the investigator, might
interfere with the evaluation of the study objectives (e.g patient unable to
complete DLQI, or poor predictable observance
- Participation in another interventional research on health products studies
- Patients requiring repeated (more than 3/year) use of antibiotics for a chronic
disease other than HS
- Alcohol-dependant patients defined as an addiction to alcohol with a negative impact
on health, social or personal life
Exclusion criteria:
Pregnancy QT prolongation Abnormal result of routine lab tests corresponding to
contra-indication to study treatments Unauthorized drug for the study during all the
study (from study treatments interactions listed in the SmPC, Cf. unauthorized drug
listed in non-inclusion criteria).
Development of hypersensitivity to any of the study products and/or excipients (e.g.
lactose, corn starch, riboflavin).