Adapted antibiotic treatment for Hurley stage 2 hidradenitis suppurativa

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

This trial tests whether a tailored sequence of antibiotics works better than 12 weeks of lymecycline for adults under 60 with active Hurley stage 2 hidradenitis suppurativa.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Institut Pasteur (industry)
• Locations: 4 sites (Marseille and 3 other locations)
• Trial ID: NCT05821478 on ClinicalTrials.gov

What this trial studies

The trial randomizes adults with active Hurley stage 2 hidradenitis suppurativa to an experimental, sequenced antibiotic regimen targeted at pathobionts identified in HS lesions versus a control arm receiving 12 weeks of lymecycline, with double-blind treatment through week 12. The experimental arm receives an initial 3-week ceftriaxone + metronidazole course, then 3 weeks of rifampicin + moxifloxacin + metronidazole, followed by 6 weeks of rifampin + moxifloxacin; the control arm receives lymecycline for 12 weeks. After week 12 all participants transition to standard-of-care maintenance antibiotics per French dermatology guidelines, decided by the investigator. Key inclusion criteria include age under 60, Hurley stage 2 disease, at least 1 year of disease and ≥4 flares in the prior year, BMI <35, and French health insurance coverage.

Who should consider this trial

Good fit: Ideal candidates are adults under 60 with active Hurley stage 2 hidradenitis suppurativa of at least one year and ≥4 flares in the previous year, BMI <35, and coverage by the French health system.

Not a fit: Patients unlikely to benefit include those with Hurley stage 1 or 3 disease, age 60 or older, BMI ≥35, pregnant people or those unable to use required contraception, or individuals whose disease is driven primarily by nonbacterial inflammatory mechanisms or fixed scarring.

Why it matters

Potential benefit: If successful, the targeted antibiotic sequence could clear lesions faster and extend relapse-free periods compared with standard lymecycline.

How similar studies have performed: Tetracyclines are a standard treatment with modest benefits and some small studies have shown partial success with multi-drug antibiotic combinations, but this specific pathobiont-targeted sequenced approach is relatively novel.

Eligibility 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).

Where this trial is running

Marseille and 3 other locations

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

Study contacts

• Principal investigator: Maïa Delage-Toriel, MD — Institut Pasteur
• Study coordinator: Maïa Delage-Toriel, MD

Conditions: Hidradenitis Suppurativa, Antibioresistance, Antibiotherapy