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Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

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ClinicalTrials.gov Identifier: NCT02696031
Recruitment Status : Active, not recruiting
First Posted : March 2, 2016
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 followed by an optional 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Condition or disease Intervention/treatment Phase
Non-radiographic Spondyloarthritis Drug: Secukinumab Drug: Placebo Phase 3

Detailed Description:

This was a randomized, double-blind, placebo-controlled study. Approximately 555 patients were randomized to one of three treatment groups (secukinumab 150 mg Load, secukinumab 150 mg No Load or placebo in a ratio of 1:1:1):

  • Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. prefilled syringe (PFS) at baseline (BSL), Weeks 1, 2 and 3, followed by administration every four weeks starting at Week 4
  • Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, placebo at Weeks 1, 2 and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
  • Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This was a randomized, double-blind, placebo-controlled study. Approximately 555 patients were randomized to one of three treatment groups (secukinumab 150 mg Load, secukinumab 150 mg No Load or placebo in a ratio of 1:1:1):

  • Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. prefilled syringe (PFS) at baseline (BSL), Weeks 1, 2 and 3, followed by administration every four weeks starting at Week 4
  • Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, placebo at Weeks 1, 2 and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
  • Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
Actual Study Start Date : April 29, 2016
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Secukinumab
Secukinumab 150 mg s.c.
 Drug: Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Other Name: AINN457

Drug: Secukinumab
150 mg Secukinumab s.c. monthly
Other Name: AIN457

Drug: Secukinumab
Dose escalation to 300mg at Year 2
Other Name: AIN457
Placebo Comparator: Placebo
Placebo s.c.
 Drug: Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Other Name: AIN457
Experimental: Experimental
Secukinumab 150 mg s.c. no load
 Drug: Secukinumab
150 mg Secukinumab s.c. monthly
Other Name: AIN457


Outcome Measures
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Primary Outcome Measures :
  1. The Proportion of TNF Naive Participants Who Achieved an ASAS 40 Response (Assessment of SpondyloArthritis International Society Criteria) [ Time Frame: Week 16 ]
    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain

  2. The Proportion of TNF Naive Participants Who Achieved an ASAS 40 Response (Assessment of SpondyloArthritis International Society Criteria) [ Time Frame: Week 52 ]
    (Table 11-2) ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain


Secondary Outcome Measures :
  1. The Proportion of Participants Who Achieved an ASAS 5/6 [ Time Frame: Week 16 ]
    The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains

  2. Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) Over Time [ Time Frame: Week 16 ]
    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS

  3. Change in SF-36 (Short Form-36 Physical Component Summary) Physical Component Summary Over Time [ Time Frame: Week 16 ]
    The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions

  4. The Proportion of Patients to Achieve a BASDAI 50 Response [ Time Frame: Week 16 and 52 ]
    The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline.

  5. Change in Sacroiliac Joint Edema [ Time Frame: Week 16 and 52 ]
    MRI assessment of the Sacroiliac Joint. The comparison of SIJ edema score at Week 52 between secukinumab 150 mg No Load vs.placebo (H19) and between secukinumab 150 mg Load vs. placebo (H32) using FAS2 were not tested at week 16, since the Week 52 MRI reading campaign was not performed until all patients had completed Week 52

  6. Change in High Sensitivity C-reactive Protein Over Time [ Time Frame: Week 16 ]
    high sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study

  7. Change in BASFI (Bath Ankylosing Spondylitis Functional Index) Over Time [ Time Frame: Week 16 ]
    The BASFI (Bath Ankylosing Spondylitis Functional Index) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS.

  8. The Proportion of Participants Who Achieved an ASAS 20 Response [ Time Frame: Week 16 ]
    ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain

  9. Change in ASQoL (Ankylosing Spondylitis Quality of Life Scores) Over Time - Week 16 [ Time Frame: Week 16 ]
    The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis

  10. The Proportion of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease [ Time Frame: Week 52 ]
    The Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) inactive disease criteria are defined as a value below 1.3 of a composite

  11. Change in ASQoL (Ankylosing Spondylitis Quality of Life Scores) Over Time - Week 52 [ Time Frame: Week 52 ]
    The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis

  12. Change in Sacroiliac Joint Edema - Week 52 [ Time Frame: Week 52 ]
    MRI assessment of the Sacroiliac Joint. The comparison of SIJ edema score at Week 52 between secukinumab 150 mg No Load vs.placebo (H19) and between secukinumab 150 mg Load vs. placebo (H32) using FAS2 were not tested at week 16, since the Week 52 MRI reading campaign was not performed until all patients had completed Week 52


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female patients at least 18 years of age
  • Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
  • objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
  • active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
  • Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
  • Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
  • Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
  • Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria:

  • Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
  • Inability or unwillingness to undergo MRI
  • Chest X-ray or MRI with evidence of ongoing infectious or malignant process
  • Patients taking high potency opioid analgesics
  • Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
  • Pregnant or nursing (lactating) women
Contacts and Locations
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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): NCT02696031


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 11, 2018
Statistical Analysis Plan  [PDF] February 5, 2019

More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02696031    
Other Study ID Numbers: CAIN457H2315
First Posted: March 2, 2016    Key Record Dates
Results First Posted: August 7, 2020
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
non-radiographic spondyloarthritis
axial spondyloarthritis
Ankylosing Spondylitis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
 Arthritis
Joint Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs