Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients

• Status: Not yet recruiting
• Trial end date: 2026-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Pasteur
• Collaborators: Assistance Publique Hopitaux De Marseille; Centre Hospitalier Universitaire de Caen; Hôpital Necker-Enfants Malades; Ministry of Health, France
• Treatments: Ceftriaxone; Metronidazole; Rifampin

Criteria

Inclusion Criteria:

• 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).