Phase 2, randomized, double-blind, placebo-controlled study of IC0624 as first-line therapy in patients with active mild to moderate Hidradenitis Suppurativa (HS)

Ki vehet részt

• Written informed consent prior to any study-related measure
• Male, female, diverse subjects aged 18 to 65 years
• Skin type Fitzpatrick I-VI
• Clinically confirmed diagnosis of mild to moderate Hidradenitis Suppurativa (HS)
• IHS4 of a minimum of 1 (corresponding to the existence of one node) and a maximum of 10 with nodes and abscesses being predominantly located in inguinal, axillar, and gluteal area
• Hurley Stage I to II
• Expected high patient compliance in administering the study medication and following the study instructions including diary documentation

Ki nem vehet részt

• Current treatment with tetracyclines
• Patients participating in another clinical study (medical devices, or medicinal products) during the 4 weeks before inclusion into this clinical trial and during the course of this clinical trial
• Systemic treatment with clindamycin, rifampicin, doxycycline, minocycline, or erythromycin for any reason within the 4 weeks preceding Visit 1
• Axillary, inguinal or anogenital treatment with topical antibiotics within the 4 weeks preceding Visit 1
• Treatment with Janus kinase (JAK) inhibitors or HS specific antibodies within 12 weeks preceding Visit 1
• Any previous randomization into this clinical trial
• Any suspicion of current drug or alcohol abuse
• Evidence of any clinically significant or unstable medical condition, that in the view of the investigator would jeopardize patient´s safety in the setting of the clinical trial
• Subjects of childbearing potential not using or not willing to use a highly effective method of contraception (failure rate of less than 1% per year) during the clinical trial
• Hypersensitivity to sulfonated shale oils, such as ammonium and/or sodium bituminosulfonate and/or any of the investigational product’s excipients
• Rare hereditary galactose or fructose intolerance, lactase deficiency, saccharase-isomaltase deficiency or glucose-galactose malabsorption
• Severe Hidradenitis Suppurativa (HS)
• IHS4 of 11 or higher
• Diagnosis of acne conglobata
• Pregnant or breast-feeding patients
• Hurley stage III
• Institutionalization because of legal or regulatory order
• Dependency (as an employee or relative) to the sponsor/responsible CRO or investigator or members of the investigational team