Extension study to assess effects of non-interrupted versus interrupted and long term treatment of two dose regimens on efficacy and safety in subjects with moderate to severe hidradenitis suppurativa

JRCT ID: jRCT2080225212

Registered date:29/05/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Hidradenitis Suppurativa
• Date of first enrollment: 09/06/2020
• Target sample size: 745
• Countries of recruitment: Japan,North America,Europe
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Time to loss of response up to Week 104 (Randomized Withdrawal period) in subjects who were HiSCR responders at Week 52 in the core studies.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- written informed consent must be obtained before any assessment is performed
- subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2

Exclude criteria

- protocol deviation in the core study which will prevent the meaningful analysis of the extension study
- ongoing or planned use of prohibited HS or non-HS treatment
- participation in the extension could expose the subject to an undue safety risk
- current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.

Related Information

• Primary Sponsor: Novartis Pharma. K.K.
• Secondary ID(s): NCT04179175,JapicCTI-205308