NCT05821478 Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients
| NCT ID | NCT05821478 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institut Pasteur |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 92 participants in total. It began in 2025-05-22 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative
Eligibility Criteria
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).
Contact & Investigator
Maïa Delage-Toriel, MD
PRINCIPAL INVESTIGATOR
Institut Pasteur
Frequently Asked Questions
Who can join the NCT05821478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05821478 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 92 participants.
Is NCT05821478 currently recruiting?
Yes, NCT05821478 is actively recruiting participants. Contact the research team at maia.delage-toriel@pasteur.fr for enrollment information.
Where is the NCT05821478 trial being conducted?
This trial is being conducted at Marseille, France, Paris, France, Paris, France, Rouen, France.
Who is sponsoring the NCT05821478 clinical trial?
NCT05821478 is sponsored by Institut Pasteur. The principal investigator is Maïa Delage-Toriel, MD at Institut Pasteur. The trial plans to enroll 92 participants.