Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04179175
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 (NCT 0313632) and AIN567M2302 (NCT03713619).

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: secukinumab Phase 3

Detailed Description:

This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268.

Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260.

Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR reponse at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 745 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized withdrawal extension, parallel group study followed by an open-label, active-treatment period with two secukinumab dose regimens in approximately 745 patients with moderate to severe HS
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients considered HiSCR responders will be randomized 2:1 to continue their current regimen or undergo withdrawal to placebo. HiScr non-responders will enter open label therapy with secukinumab if desired
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 18, 2020
Estimated Primary Completion Date : December 21, 2022
Estimated Study Completion Date : February 18, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Active Comparator: secukinumab 1 HiSCR Responder
HiSCR responder in core trial, secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 or every 4 weeks
Other Name: AIN457

Active Comparator: secukinumab 2 HiSCR Responder
HiSCR responder in core trial, secukinumab 300mg every 4 weeks
Drug: secukinumab
secukinumab 300mg every 2 or every 4 weeks
Other Name: AIN457

Placebo Comparator: placebo 1 HiSCR Responder
HiSCR responder in core trial, placebo to secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 or every 4 weeks
Other Name: AIN457

Placebo Comparator: placebo 2 HiSCR Responder
HiSCR responder in core trial, placebo to secukinumab 300 mg every 4 weeks
Drug: secukinumab
secukinumab 300mg every 2 or every 4 weeks
Other Name: AIN457

Active Comparator: HiSCR non-responders
non-responder to core trial treatment; secukinumab 300mg every 2 weeks
Drug: secukinumab
secukinumab 300mg every 2 or every 4 weeks
Other Name: AIN457




Primary Outcome Measures :
  1. time to loss of response (LOR) in HiSCR reponders [ Time Frame: Weeks 52 - 104 ]

    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 .


Secondary Outcome Measures :
  1. Cumulative rate of subjects who experience a flare in core HiScr responders [ Time Frame: Week 104 ]
    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.

  2. subjects achieving NRS30 [ Time Frame: Week 104 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179175


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 72 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04179175    
Other Study ID Numbers: CAIN457M2301E1
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
acne inversa
Hidradenitis suppurativa
maladie de Vemeuil
inflammatory disease
AIN457
AIN457M
secukinumab
Loss of response
HiSCR
IL-17A
Additional relevant MeSH terms:
Layout table for MeSH terms
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration