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A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa (SUNSHINE)

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

Yamada Hiroyuki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Yamada Hiroyuki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

completed

April. 30, 2019

Interventional

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.

treatment purpose

3

- 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.

- 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.

Both

Hidradenitis Suppurativa

investigational material(s)
Generic name etc :
INN of investigational material : Secukinumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Secukinumab 300mg every 2 or every 4 weeks

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :Placebo 300mg every 2 or every 4 weeks

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.

Jan. 24, 2019