Adapted antibiotic treatment for Hurley stage 2 hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Médical de l'Institut Pasteur
  Paris, France Recruiting
• Hôpital de la Timone
  Marseille, France Not yet 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
• Email: maia.delage-toriel@pasteur.fr
• Phone: +33 1 40 61 30 77

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Remibrutinib extension study for adults with moderate to severe hidradenitis suppurativa

  This extension study tests whether continuing remibrutinib is safe and helps skin symptoms in adults who completed prior HS trials.

  Recruiting at 61 sites Phase 3 Novartis · Birmingham, Alabama and 60 other locations · NCT07665437

• LAD328 in adults with hidradenitis suppurativa

  This study tests whether LAD328 works better than placebo for adults with moderate-to-severe hidradenitis suppurativa.

  Recruiting Phase 2 Almirall, S.A. · Warsaw, Masovian Voivodeship · NCT07547813

• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

  This project will see how secukinumab works and is used in adults with moderate to severe hidradenitis suppurativa in Italy.

  Recruiting at 16 sites Novartis · Ancona, AN and 15 other locations · NCT07543419

• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

  Recruiting at 15 sites Novartis · Calgary, Alberta and 14 other locations · NCT07282015

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.