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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

NCT04179175 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2026-03-11

Study results available
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Summary

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).

Conditions

Interventions

DRUG

secukinumab

secukinumab 300mg every 2 weeks

DRUG

secukinumab

secukinumab 300mg every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2023-05-26
Completion
2026-07-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • France
  • Germany
  • Greece
  • Guatemala
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Lithuania
  • Malaysia
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179175 on ClinicalTrials.gov