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Taking peoplePhase 3

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

Key facts

Who runs it
Institut Pasteur
Where
France8 sites in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 3
People taking part
92 people, planned
Started
22 May 2025
Expected to end
27 Feb 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy
  • Lymecyclin and corresponding placebos of the experimental arm
Record updated
9 July 2025

Who can take part

Age
18 years to 59 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin)
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 59 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Experimental treatmentTreatment being tested

    a 3-week course of ceftriaxone (Rocephin) IV injection (daily dose 2g/day) \+ oral metronidazole (daily dose 1500mg) followed by a 3-week course of oral rifampicin (Rifadin with 10mg/kg/day) + moxifloxacin (Izilox daily dose 400mg) + metronidazole (daily dose 1500mg) followed by a 6-week course of oral rifampicin (Rifadin with 10mg/kg/day) + moxifloxacin (Izilox daily dose 400mg). A placebo for lymecycline will also be administered during this intensive treatment phase

    Treatment: ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy

  • ControlExisting treatment, for comparison

    12-week course of oral lymecycline (Tetralysal daily dose 452mg) Placebos for all experimental drugs will also be administered during this intensive treatment phase

    Treatment: Lymecyclin and corresponding placebos of the experimental arm

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Fit questions
Built from NCT05821478, who can take part
Record updated
9 July 2025