Study of efficacy and safety of two secukinumab dose regimens in subjects with moderate to severe hidradenitis suppurativa

Phase 3

Completed

• Conditions: Hidradenitis Suppurativa

• Registration Number: jRCT2080224602
• Lead Sponsor: Novartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-20
• Last Update Posted: 2023-04-08

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 541

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: This is a multicenter, randomized, double-blind, placebo controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate tosevere HS.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)	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.

Trial Locations

Locations (1)

Japan/Asia except Japan/North America/South America/Europe/Oceania/null; Location not specified

Japan/Asia except Japan/North America/South America/Europe/Oceania/null