Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• secukinumab — DRUG
  secukinumab 300mg every 2 weeks
• secukinumab — DRUG
  secukinumab 300mg every 4 weeks

Study Details

The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

Key Dates

Start date

Mar 18, 2020

Status verified

Mar 2026

Primary completion

May 26, 2023

Completion

Jul 15, 2026

Study Design

Enrollment

703 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: secukinumab 1 HiSCR Responder
  HiSCR responder at Week 52 in core trial, secukinumab 300mg every 2 weeks
• Active Comparator: secukinumab 2 HiSCR Responder
  HiSCR responder at Week 52 in core trial, secukinumab 300mg every 4 weeks
• Placebo Comparator: placebo 1 HiSCR Responder
  HiSCR responder at Week 52 in core trial, placebo to secukinumab 300mg every 2 weeks
• Placebo Comparator: placebo 2 HiSCR Responder
  HiSCR responder at Week 52 in core trial, placebo to secukinumab 300 mg every 4 weeks
• Other: HiSCR non-responders
  non-responder at Week 52 in core trial treatment; secukinumab 300mg every 2 weeks

Primary Outcome Measure

Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders [ Time Frame: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies. ]

Locations (29)

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