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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04179175
Ethics application status
Date submitted
25/11/2019
Date registered
27/11/2019
Date last updated
19/09/2024

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
2019-003230-17
Secondary ID [2] 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
Treatment: Drugs - secukinumab

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


Treatment: Drugs: secukinumab
secukinumab 300mg every 2 weeks

Treatment: Drugs: secukinumab
secukinumab 300mg 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) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Reponders
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events
Timepoint [1] 0 0
Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.

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 had received secukinumab treatment during Treatment Period 2
Minimum age
18 Years
Maximum age
No limit
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/07/2026
Actual
Sample size
Target
Accrual to date
Final
701
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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Talas Kayseri
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London
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Barnsley
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Hanoi
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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 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).
Trial website
https://clinicaltrials.gov/study/NCT04179175
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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