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 (ABCESS2)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Pasteur

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

22 May 2025 → ongoing

Decision date (initial)

2023-07-31

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS French Health Ministry · Association Française pour la Recherche sur L’Hidrosadénite (AFRH) · La Roche Posay

External identifiers

EU CT number

2023-505818-16-00

EudraCT number

2022-003562-20

ClinicalTrials.gov

NCT05821478

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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 objectives 8

1. Efficacy of the experimental treatment:To measure the clinical efficacy at week 6, week 24 and week 52
2. Efficacy of the experimental treatment:To measure microbiological efficacy at week 12
3. Efficacy of the experimental treatment : To evaluate the impact on pain and quality of life
4. Efficacy of the experimental treatment: To quantify the use of additional treatments
5. Efficacy of the experimental treatment: To characterize the number of HS flares after clinical remission
6. Efficacy of the experimental treatment: To identify prognosis markers of response to treatments
7. Safety of the experimental treatment: To evaluate clinical and biological tolerance
8. Safety of the experimental treatment: To identify emergence of multidrug resistance in the gut microflora

Conditions and MedDRA coding

Hurley stage 2 active Hidradenitis Suppurativa

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Adults < 60 years old
2. 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)
3. Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year and iii) at least one active lesion at inclusion, i.e. inflammatory/suppurative
4. Clinical severity of HS at inclusion: Hurley stage 2
5. BMI < 35
6. Written informed consent from patient
7. Patient able to complete DLQI
8. Patients affiliated to the French health system (Assurance Maladie), except French state medical aid beneficiaries (Aide Médicale d'Etat)
9. Active compatible contraception for men and women of childbearing or inability to procreate
10. Available laboratory blood test performed within the last 2-months.

Exclusion criteria 18

1. Person < 18 and ≥ 60 years old
2. Former stage 3 HS
3. Previous use of antibiotics within the last 3 weeks preceding the inclusion
4. Previous use of the experimental treatment
5. Unauthorized drugs for the study preceding the inclusion
6. Any contra-indication to study treatments or excipient (e.g. lactose, cornstarch, riboflavin notably): - pregnancy, breastfeeding, - Patients with potential cross allergy to ceftriaxone (allergy already known to penicillin) - 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
7. Unbalanced diabetes (ie HbA1c above 7%)
8. Dysphagia, untreated gastro-oesophageal reflux/ulcer
9. BMI ≥ 35
10. Immune suppression (including history of any cancer ≤ 5 years), inflammatory disease, including gastroenterologic and rheumatologic inflammatory conditions, or on biological treatment during the month preceding the inclusion
11. Alcohol-dependants patients defined as an addiction to alcohol with a negative impact on health, social or personal life
12. Lactase deficiency, lactose and galactose intolerance
13. Malabsorption syndrome
14. Person living in the same household as another patient
15. Person under guardianship or curatorship
16. 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)
17. Participation in another interventional research on health products studies
18. Patients requiring repeated (more than 3/year) use of antibiotics for a chronic disease other than HS

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 9

1. Efficacy: Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit
2. Efficacy: Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion
3. Efficacy: Patient's HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI)
4. Efficacy: Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages
5. Efficacy : Time without flare of HS after remission, number of flares using a patient journal
6. Efficacy: Identification of prognosis markers of response to treatments
7. Safety: Description of adverse events related to treatments
8. Safety: Description of adverse events related to protocol procedures other than treatments
9. Safety: Emergence of extended spectrum betalactamase and carbapenemase producing enterobacteriaceae as well as vancomycin resistant enterococci in the gut microflora

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Comparator 1

Placebo 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Pasteur

Sponsor organisation

Institut Pasteur

Address

28 Rue Du Docteur Roux

City

Paris

Postcode

75015

Country

France

Scientific contact point

Organisation

Institut Pasteur

Contact name

JOLLY Nathalie

Public contact point

Organisation

Institut Pasteur

Contact name

JOLLY Nathalie

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications