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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04179175




Registration number
NCT04179175
Ethics application status
Date submitted
25/11/2019
Date registered
27/11/2019
Date last updated
4/05/2021

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
CAIN457M2301E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - secukinumab

Active Comparator: secukinumab 1 HiSCR Responder - HiSCR responder in core trial, secukinumab 300mg every 2 weeks

Active Comparator: secukinumab 2 HiSCR Responder - HiSCR responder in core trial, secukinumab 300mg every 4 weeks

Placebo Comparator: placebo 1 HiSCR Responder - HiSCR responder in core trial, placebo to secukinumab 300mg every 2 weeks

Placebo Comparator: placebo 2 HiSCR Responder - HiSCR responder in core trial, placebo to secukinumab 300 mg every 4 weeks

Active Comparator: HiSCR non-responders - non-responder to core trial treatment; secukinumab 300mg every 2 weeks


Treatment: Drugs: secukinumab
secukinumab 300mg every 2 or every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
time to loss of response (LOR) in HiSCR reponders - Loss of response is defined as:
at least a 50% increase in abscess and/or nodules count (AN) compared to the average AN count from the 3 previous visits and the increase was at least of 3 AN from the average AN count of the 3 previous visits.
at least a 30% increase in AN compared to the average AN count from the 3 previous visits with an increase of at least 2 AN from the average count of the 3 previous visits or a further increase in the AN count of at least 2 AN .
Timepoint [1] 0 0
Weeks 52 - 104
Secondary outcome [1] 0 0
Cumulative rate of subjects who experience a flare in core HiScr responders - subjects who experience at least one flare by Week 104. flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.
Timepoint [1] 0 0
Week 104
Secondary outcome [2] 0 0
subjects achieving NRS30 - HS-related skin pain; subjects achieving NRS30 at week 104, defined as at least a 30% reduction and at least one unit reduction from baseline in the subject's Global Assessment of Skin Pain
Timepoint [2] 0 0
Week 104

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Phillip
Recruitment hospital [2] 0 0
Novartis Investigative Site - Benowa
Recruitment hospital [3] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
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United States of America
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04179175
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04179175