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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT05821478

Run by

Institut Pasteur

People needed

92

Starts

2025-05-22

Expected to finish

2028-02-27

Last updated by the study team

2025-07-09

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Centre Médical de l'Institut Pasteur — Paris, France (enrolling)
• Hôpital de la Timone — Marseille, France
• Hopital St Joseph — Paris, France
• CHU de Rouen — Rouen, France

Full record on ClinicalTrials.gov

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