Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
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Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solution for solution for inje
Sponsors
INSTITUT PASTEUR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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, corn starch, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of a 3-week course of a ceftriaxone+metronidazole treatment followed by 3 weeks of a rifampicin+moxifloxacin+metronidazole combination, then 6 weeks of rifampicin+moxifloxacin (experimental treatment) over a 12-week course of tetracycline-derivative (control treatment) in patients with Hurley stage 2 HS (Hidradenitis suppurativa) at week 12. ;Secondary Objective: Efficacy of the experimental treatment: - To measure the clinical efficacy at week 6, week 24 and week 52 - To measure microbiological efficacy at week 12 - To evaluate the impact on pain and quality of life - To quantify the use of additional treatments - To characterize the number of HS flares after clinical remission - To identify prognosis markers of response to treatments Safety of the experimental treatment: - To evaluate clinical and biological tolerance - To identify emergence of multidrug resistance in the gut microflora;Primary end point(s): Percentage of patients reaching clinical remission at week 12, défined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1));Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit - Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion - Patient’s HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI) - Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages - Time without flare of HS after remission, number of flares using a patient journal - Identification of prognosis markers of response to treatments: Patient’s personal and familial history, lesions localization and characteristics, clinical examination, Body Mass Index (BMI) Past antimicrobial treatments Microbiome of the worst lesion at baseline Microbiome of relapsing or resistant lesions Observance of the study treatment CRP, CBC, blood glucose Safety: Description of adverse events related to treatments Description of adverse events related to protocol procedures other than treatments Emergence of extended spectrum betalactamase and carbapenemase producing enterobacteriaceae as well as vancomycin resistant enterococci in the gut microflora ;Timepoint(s) of evaluation of this end point: At weeks 6, 12, 24 and 52 | — |
Countries
France
Contacts
Public ContactJOLLY nathalie
CRT-CC
Outcome results
None listed