Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
ABCESS2
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 27, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Brief Summary
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
recruiting
Estimated enrollment
92 participants
Study completion date
February 27, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations
1 countries · 4 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
April 16, 2019
Actual (reported)
First Posted
April 20, 2023
Actual (reported)
Study Start
May 22, 2025
Actual (reported)
Primary Completion
February 28, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 27, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
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
+16 more secondary outcomes
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
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
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 armDrug
Registry intervention entries
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Avalox® 400 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
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.
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.
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):
+13 more criteria
You may not qualify if:
Development of hypersensitivity to any of the study products and/or excipients (e.g. lactose, corn starch, riboflavin).
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 27, 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 9, 2025
Record last verified: 2025-07
Data Sharing
IPD Sharing
Will share
All IPD that underlie results in a publication
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
Source records
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Source: ClinicalTrials.gov.
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