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.

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. - CAIN457M2301E1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54433

Enrollment

Registered

2020-08-19

Start date

2021-02-04

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Hidradenitis suppurativa

Interventions

* Secukinumab 300 mg solution for s.c. injection in a 2 ml PFS * Placebo solution for s.c. injection in a 2 ml PFS

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Subjects who complete the whole study treatment period (52 weeks) in the core studies (CAIN457M2301 or CAIN457M2302) and have received secukinumab treatment during the Treatment Period 2 of the core studies.

Exclusion criteria

Exclusion criteria: 1. A protocol deviation in the core study which, according to the investigator will prevent the meaningful analysis of the extension study for the individual subject. 2. Ongoing or planned use of prohibited HS or non-HS treatments. Time of use of prohibited treatments in the core study must continue to be adhered to (see Table 6-2) 3. Subjects not expected to benefit from participation in the extension study, as assessed by the subject and investigator. 4. Subjects whose participation in the extension study could expose them to an undue safety risk. 5. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the study. 6. Plans for administration of live vaccines during the study. 7. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception.

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. HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae.	—

Secondary

Measure	Time frame
To assess the long-term safety and tolerability of secukinumab in subjects with moderate to severe HS using adverse events, laboratory values, vital signs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)