Hidradenitis Suppurativa
Conditions
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of HS >= 1 year prior to baseline. - Patients with moderate to severe HS defined as: A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND Inflammatory lesions should affect at least 2 distinct anatomic areas - Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.
Exclusion criteria
Exclusion criteria: - Total fistulae count >= 20 at baseline. - Any other active skin disease or condition that may interfere with assessment of HS. - Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications. - Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to. - History of hypersensitivity to any of the study drug constituents. - History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). - Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR) [ Time Frame: 16 weeks ] HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae. | — |
Countries
Asia except Japan, Europe, Japan, North America, null, Oceania, South America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed