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NCT Number: NCT05821478

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

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

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital de la Timone, Marseille, France

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About this study

The antibiotic strategy is targeted against specific pathobionts which have been identified in HS lesions by the investigator's team.

Half of participants will receive a 3-week course of ceftriaxone + metronidazole treatment followed by 3 weeks of rifampicin + moxifloxacin + metronidazole combination, then 6 weeks of rifampin + moxifloxacin (experimental groupe), versus a 12 weeks course of lymecycline (control group) Double blind treatment phase will stop at week 12. All patients whatever their randomization arm or their remission status will begin follow-up treatment according to standard care recommendations (Société Française de Dermatologie): lymecycline, doxycycline or cotrimoxazole. Prescription will be upon decision of the investigator.

This maintenance treatment is not experimental.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: Experimental treatment

Lymecyclin and corresponding placebos of the experimental arm

Drug

12-week course of oral lymecycline.

Other names: Control treatment

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))

    Time frame: at week 12

    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.

Secondary outcomes

  1. Change in Physician Global Assessment (PGA)

    Time frame: from baseline to week 52

    Physician assessment describe by differents severity : from Clear (no nodule) to Very severe (more than 5 abscesses or fistulas) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  2. Change in Modified Sartorius score

    Time frame: from baseline to week 52

    Score calculated by points from 0 (better) with differents parameters involved such as location / number / size / type of lesions Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  3. Change in Hurley Score

    Time frame: from baseline to week 52

    Score described with 3 stages from I (less severity) to III (most severe) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  4. Change in Hidradenitis Suppurativa Severity Score (IHS4) score

    Time frame: from baseline to week 52

    Score calculated by points from <3pts (Mild) to > 11pts (Severe) by nb of nodules, nb of abscesses and nb of draining tunnels Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  5. Change in Hidradenitis Suppurativa Clinical Response (HiSCR) score

    Time frame: from baseline to week 52

    Global Assessment score of clear, minimal, or mild evaluated by (i) at least a 50% reduction in AN (abscess and nodule count), (ii) no increase in the number of abscesses and (iii) no increase in the number of draining fistulas from baseline Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  6. Change in Dermatology Life Quality Index (DLQI) score (Patient's HS evaluation)

    Time frame: from baseline to week 52

    Evaluated with the Dermatology Life Quality Index (DLQI) Score calculated by points from 0 to 30 following patient answers on quality of life questions Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  7. Change of patient pain

    Time frame: from baseline to week 52

    Intensity of pain evaluated with the visual analog scale (VAS) from 0 (no pain) to 10 (pain as bad as it could possible be) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

  8. Microbiological bacterial Change on the worst lesion microbiome at W12

    Time frame: at baseline and week 12

    By identification of microbiology bacterial metagenomics (by skin lesional swab sample)

  9. Microbiological metagenomics Change on the worst lesion microbiome at W12

    Time frame: at baseline and week 12

    By identification of multidrug resistant bacteria (by rectal swab sample)

  10. Number of pain killers received by patients

    Time frame: from baseline to week 52

    Number of pain killers prescribed for flares (acute worsening of one or more HS lesions)

  11. Number of antibiotic treatments received by patients

    Time frame: from baseline to week 52

    Number of antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions)

  12. Time without flare of HS

    Time frame: from baseline to week 52

    Evaluated by number of flares reported or not using a patient journal

  13. Change in BMI

    Time frame: from baseline to week 52

    Calculated by combined weight and height measures

  14. Abnormal biological value of Hemoglobin

    Time frame: from baseline to week 12

    measured in g/L, compared to normal ranges

  15. Abnormal biological value of white cells

    Time frame: from baseline to week 12

    measured in units of cells / mm3 , compared to normal ranges

  16. Abnormal biological value of neutrophils

    Time frame: from baseline to week 12

    measured in units of cells / mm3 , compared to normal ranges

  17. Abnormal biological value of platelet count

    Time frame: from baseline to week 12

    measured in units of cells / mm3 , compared to normal ranges

  18. Abnormal value of AST liver enzyme

    Time frame: from baseline to week 12

    AST value > 4 x Upper limit of normal

  19. Abnormal value of ALT liver enzyme

    Time frame: from baseline to week 12

    ALT value > 4 x Upper limit of normal

  20. Number of adverse events of all kind

    Time frame: from baseline to week 52

    AE defined by SOC and PT according to MedDra dictonnary

  21. Non complete drug administration

    Time frame: from baseline to week 12

    Evaluated by total number of capsules not taken according to patient journal

Study contacts

Contact information is provided by the study sponsor or research team.

Aude Nassif, MD

CONTACT

[email protected]

01 40 61 30 77

Maïa Delage-Toriel, MD

CONTACT

[email protected]

+33 1 40 61 30 77

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

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

Registry information

Official study 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

Acronym: ABCESS2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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