Hidradenitis SuppurativaPhase 3ABCESS2NCT05821478
Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
A Phase 3 study of Hidradenitis Suppurativa, run by Institut Pasteur at 4 sites in France.
Trial summary
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Hidradenitis Suppurativa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 4 sitesFrance
- Study dates
- 22 May 2025to 27 Feb 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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 join
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 3 recruiting
- Not yet recruiting
Hôpital de la Timone
Marseille
Marie-Aleth Richard, MD, PhD, MarieAleth.RICHARD@ap-hm.fr
- Recruiting
Centre Médical de l'Institut Pasteur
Paris
Maïa Delage-Toriel, MD, maia.delage-toriel@pasteur.fr
Aude Nassif
- Active, not recruiting
Hopital St Joseph
Paris
- Not yet recruiting
CHU de Rouen
Rouen
Anne-Bénédicte Duval-Modeste, Dr, AB.Duval-Modeste@chu-rouen.fr
About this study
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
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
Read the detailed description
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy, Lymecyclin and corresponding placebos of the experimental arm
- Keywords
- Hidradenitis Suppurativa, Antibioresistance, Antibiotherapy
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapyDrug
Also called Experimental treatment
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
Lymecyclin and corresponding placebos of the experimental armDrug
Also called Control treatment
12-week course of oral lymecycline.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lymecyclin and corresponding placebos of the experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 12
Secondary outcomes (21)
Change in Physician Global Assessment (PGA)
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
Measured: from baseline to week 52
Change in Modified Sartorius score
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
Measured: from baseline to week 52
Change in Hurley Score
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
Measured: from baseline to week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4) score
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
Measured: from baseline to week 52
Change in Hidradenitis Suppurativa Clinical Response (HiSCR) score
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
Measured: from baseline to week 52
Change in Dermatology Life Quality Index (DLQI) score (Patient's HS evaluation)
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
Measured: from baseline to week 52
Change of patient pain
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
Measured: from baseline to week 52
Microbiological bacterial Change on the worst lesion microbiome at W12
By identification of microbiology bacterial metagenomics (by skin lesional swab sample)
Measured: at baseline and week 12
Microbiological metagenomics Change on the worst lesion microbiome at W12
By identification of multidrug resistant bacteria (by rectal swab sample)
Measured: at baseline and week 12
Number of pain killers received by patients
Number of pain killers prescribed for flares (acute worsening of one or more HS lesions)
Measured: from baseline to week 52
Number of antibiotic treatments received by patients
Number of antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions)
Measured: from baseline to week 52
Time without flare of HS
Evaluated by number of flares reported or not using a patient journal
Measured: from baseline to week 52
Change in BMI
Calculated by combined weight and height measures
Measured: from baseline to week 52
Abnormal biological value of Hemoglobin
measured in g/L, compared to normal ranges
Measured: from baseline to week 12
Abnormal biological value of white cells
measured in units of cells / mm3 , compared to normal ranges
Measured: from baseline to week 12
Abnormal biological value of neutrophils
measured in units of cells / mm3 , compared to normal ranges
Measured: from baseline to week 12
Abnormal biological value of platelet count
measured in units of cells / mm3 , compared to normal ranges
Measured: from baseline to week 12
Abnormal value of AST liver enzyme
AST value > 4 x Upper limit of normal
Measured: from baseline to week 12
Abnormal value of ALT liver enzyme
ALT value > 4 x Upper limit of normal
Measured: from baseline to week 12
Number of adverse events of all kind
AE defined by SOC and PT according to MedDra dictonnary
Measured: from baseline to week 52
Non complete drug administration
Evaluated by total number of capsules not taken according to patient journal
Measured: from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start22 May 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric randomized double-blind phase 3 trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Caen, Hôpital Necker-Enfants Malades, Ministry of Health, France, Assistance Publique Hopitaux De Marseille
- Responsible party
- Sponsor
- Investigators
- Maïa Delage-Toriel, MD, Principal investigator, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821478
- Sponsor's protocol ID
- 2018-018
- Acronym
- ABCESS2
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2019
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 28379372Guet-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.
PubMed 25418454Join-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.
PubMed 21109728