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

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

ClinicalTrials.gov Identifier: NCT04179175

Novartis Reference Number: CAIN457M2301E1

Last Update: Mar 30, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 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 AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

Condition 
Hidradenitis Suppurativa
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
856 participants
Start date 
Jan 11, 2020
Completion date 
Aug 18, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
secukinumab
secukinumab 300mg every 2 or every 4 weeks

Eligibility 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:

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.

Study Locations

United States
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Rogers, 72758
Arkansas
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San Diego, 92103
California
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San Diego, 92123
California
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Whittier, 92677
California
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Coral Gables, 33134
Florida
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Tampa, 33609
Florida
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Tampa, 33612
Florida
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Sandy Springs, 30328
Georgia
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Skokie, 60077
Illinois
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West Dundee, 60118
Illinois
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Indianapolis, 46256
Indiana
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Boston, 02111
Massachusetts
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Boston, 02215
Massachusetts
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Saint Joseph, 64506
Missouri
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Saint Louis, 63104
Missouri
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Saint Louis, 63110
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Omaha, 68144
Nebraska
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New York, 10029
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Chapel Hill, 27516
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Dallas, 75246-1613
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Pflugerville, 78660
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San Antonio, 78229
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