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

NCT05821478 | Recruiting Phase 3 DMC

• 1 other identifier: 2018-018
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Antibioresistance; Antibiotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients reaching clinical remission at week 12, defined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1))

  The clinical remission is defined as a 90% improvement of the International Hidradenitis Suppurativa Severity Score (IHS4) at week 12 compared to the baseline. The IHS4 score is a validated composite score developped to assess dynamically HS severity (1). It is calculated by adding the number of inflammatory nodules to the number of abscesses multiplied by 2 and to the number of draining tunnels multiplied by 4. A total score of 3 or less corresponds to mild severity HS, 4-10 to moderate severity HS and 11 or higher to severe disease.

  at week 12

Secondary Outcomes (21)

• Change in Physician Global Assessment (PGA)

  from baseline to week 52

• Change in Modified Sartorius score

  from baseline to week 52

• Change in Hurley Score

  from baseline to week 52

• Change in Hidradenitis Suppurativa Severity Score (IHS4) score

  from baseline to week 52

• Change in Hidradenitis Suppurativa Clinical Response (HiSCR) score

  from baseline to week 52

Study Arms (2)

Experimental treatment

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

Drug: Lymecyclin and corresponding placebos of the experimental arm

Interventions

ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy DRUG

a 3-week course of ceftriaxone injection + oral metronidazole followed by a 3-week course of oral rifampicin + moxifloxacin +metronidazole followed by a 6-week course of oral rifampicin + moxifloxacin

Also known as: Experimental treatment

Experimental treatment

Lymecyclin and corresponding placebos of the experimental arm DRUG

12-week course of oral lymecycline.

Also known as: Control treatment

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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
• Person \< 18 and ≥ 60 years old
• Former stage 3 HS
• Previous use of the experimental treatment
• Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably):

You may not qualify if:

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

Sponsors & Collaborators

• Institut Pasteur: lead
• Centre Hospitalier Universitaire de Caen: collaborator
• Hôpital Necker-Enfants Malades: collaborator
• Ministry of Health, France: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator

Study Sites (4)

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

Related Publications (3)

• Guet-Revillet H, Jais JP, Ungeheuer MN, Coignard-Biehler H, Duchatelet S, Delage M, Lam T, Hovnanian A, Lortholary O, Nassif X, Nassif A, Join-Lambert O. The Microbiological Landscape of Anaerobic Infections in Hidradenitis Suppurativa: A Prospective Metagenomic Study. Clin Infect Dis. 2017 Jul 15;65(2):282-291. doi: 10.1093/cid/cix285.

  PMID: 28379372 BACKGROUND

• Guet-Revillet H, Coignard-Biehler H, Jais JP, Quesne G, Frapy E, Poiree S, Le Guern AS, Le Fleche-Mateos A, Hovnanian A, Consigny PH, Lortholary O, Nassif X, Nassif A, Join-Lambert O. Bacterial pathogens associated with hidradenitis suppurativa, France. Emerg Infect Dis. 2014 Dec;20(12):1990-8. doi: 10.3201/eid2012.140064.

  PMID: 25418454 BACKGROUND

• Join-Lambert O, Coignard H, Jais JP, Guet-Revillet H, Poiree S, Fraitag S, Jullien V, Ribadeau-Dumas F, Theze J, Le Guern AS, Behillil S, Lefleche A, Berche P, Consigny PH, Lortholary O, Nassif X, Nassif A. Efficacy of rifampin-moxifloxacin-metronidazole combination therapy in hidradenitis suppurativa. Dermatology. 2011 Feb;222(1):49-58. doi: 10.1159/000321716. Epub 2010 Nov 25.

  PMID: 21109728 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Ceftriaxone; Metronidazole; Rifampin; Moxifloxacin

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Maïa Delage-Toriel, MD

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maïa Delage-Toriel, MD

CONTACT

+33 1 40 61 30 77; maia.delage-toriel@pasteur.fr

Aude Nassif, MD

CONTACT

01 40 61 30 77; aude.nassif@pasteur.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicentric randomized double-blind phase 3 trial

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 20, 2023
• Study Start: May 22, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 27, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After publication, for 25 years
• Access Criteria: By publication in scientific journals and / or presented in scientific or medical meetings

Locations

FR (4)