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

A Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225212

Enrollment

745

Registered

2020-05-29

Start date

2020-06-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Interventions

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 Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Europe, Japan, North America

Contacts

Public ContactHiroyuki Yamada

Novartis Pharma. K.K.

rinshoshiken.toroku@novartis.com+81-120-003-293

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026