SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis (SKIPPAIN)

August 12, 2021 updated by: Novartis Pharmaceuticals

A 24-week, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Secukinumab in Controlling Spinal Pain in Patients With Axial Spondyloarthritis

The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease activity, fatigue, and predictability of disease flares in patients with axial spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess the potential additional benefits of dose escalation in patients with axSpA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consisted of 2 treatment periods: a double-blind, placebo-controlled period from Baseline to Week 8 (Treatment Period 1) and a double-blind secukinumab treatment period from Week 8 to Week 24 (Treatment Period 2).

At Baseline (Treatment Period 1), patients were randomized in a 3:1 ratio to either secukinumab 150 mg (Group A) or placebo (Group B). At Week 8 (Treatment Period 2), patients were re-randomized and re-assigned respectively to 1 of 5 treatment arms to receive either secukinumab 150 mg or secukinumab 300 mg.

Patients assigned to secukinumab 150 mg (Group A) at Baseline who were responders (i.e. spinal pain score < 4) at Week 8 continued on the same dose until Week 24 under 1 treatment arm (Arm A1). Patients assigned to secukinumab 150 mg at Baseline who were non-responders at Week 8 were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm A2) or secukinumab 300 mg (Arm A3) from Week 8 to Week 24.

Similarly, patients assigned to placebo (Group B) at Baseline were re-randomized to 1 of 2 treatment arms: secukinumab 150 mg (Arm B1) or secukinumab 300 mg (Arm B2) from Week 8 until Week 24.

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1020
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4000
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1505
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1750
        • Novartis Investigative Site
  • Croatia
      • Rijeka, Croatia, 51000
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Novartis Investigative Site
    • HRV
      • Zagreb, HRV, Croatia, 10000
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 63800
        • Novartis Investigative Site
      • Plzen-Bory, Czechia, 30599
        • Novartis Investigative Site
      • Praha 5, Czechia, 150 06
        • Novartis Investigative Site
  • Estonia
      • Parnu, Estonia, 80010
        • Novartis Investigative Site
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Novartis Investigative Site
  • Finland
      • Kuopio, Finland, 70100
        • Novartis Investigative Site
      • Kuovola, Finland, 45100
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
      • Athens, Greece, 145 61
        • Novartis Investigative Site
      • Thessaloniki, Greece, 54636
        • Novartis Investigative Site
    • Evros
      • Alexandroupolis, Evros, Greece, 681 00
        • Novartis Investigative Site
    • GR
      • Thessaloniki, GR, Greece, 564 29
        • Novartis Investigative Site
  • Ireland
      • Dublin, Ireland, D03 VX82
        • Novartis Investigative Site
      • Dublin 4, Ireland, D04 T6F
        • Novartis Investigative Site
  • Italy
    • VR
      • Verona, VR, Italy, 37134
        • Novartis Investigative Site
  • Latvia
      • Liepaja, Latvia, LV 3401
        • Novartis Investigative Site
      • Riga, Latvia, LV 1002
        • Novartis Investigative Site
      • Riga, Latvia, LV 2164
        • Novartis Investigative Site
  • Lithuania
    • LT
      • Kaunas, LT, Lithuania, LT-50128
        • Novartis Investigative Site
    • LTU
      • Kaunas, LTU, Lithuania, LT 50161
        • Novartis Investigative Site
  • Poland
      • Bydgoszcz, Poland, 85 168
        • Novartis Investigative Site
      • Sopot, Poland, 81 756
        • Novartis Investigative Site
      • Torun, Poland, 87-100
        • Novartis Investigative Site
      • Warszawa, Poland, 00-874
        • Novartis Investigative Site
      • Warszawa, Poland, 04 305
        • Novartis Investigative Site
      • Wroclaw, Poland, 53-224
        • Novartis Investigative Site
    • Mazowian
      • Warszawa, Mazowian, Poland, 02 495
        • Novartis Investigative Site
  • Russian Federation
      • Irkutsk, Russian Federation, 664046
        • Novartis Investigative Site
      • Izhevsk, Russian Federation, 426009
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420097
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115093
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Novartis Investigative Site
      • Elda, Alicante, Spain, 03600
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Novartis Investigative Site
    • Bizkaia
      • Galdakao, Bizkaia, Spain
        • Novartis Investigative Site
    • Cantabria
      • Torrelavega, Cantabria, Spain, 39300
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46014
        • Novartis Investigative Site
      • Valencia, Comunidad Valenciana, Spain, 46010
        • Novartis Investigative Site
    • Extremadura
      • Plasencia, Extremadura, Spain, 10600
        • Novartis Investigative Site
    • Galicia
      • Lugo, Galicia, Spain, 27003
        • Novartis Investigative Site
      • Orense, Galicia, Spain, 32005
        • Novartis Investigative Site
    • Islas Baleares
      • Mallorca, Islas Baleares, Spain, 07198
        • Novartis Investigative Site
    • Madrid
      • Torrejon de Ardoz, Madrid, Spain, 28850
        • Novartis Investigative Site
  • Sweden
      • Danderyd, Sweden, 182 88
        • Novartis Investigative Site
      • Halmstad, Sweden, SE 302 66
        • Novartis Investigative Site
      • Harnosand, Sweden, SE 871 31
        • Novartis Investigative Site
    • SE
      • Stockholm, SE, Sweden, 113 65
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
  • United Kingdom
      • Liverpool, United Kingdom, L9 7AL
        • Novartis Investigative Site
      • Plymouth, United Kingdom, PL6 8DH
        • Novartis Investigative Site
      • Warrington, United Kingdom, WA5 1QG
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site
    • Staffordshire
      • Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non radiographic axial spondylarthritis) according to ASAS axSpA classification criteria
  • patients with back pain for at least 3 months and age of onset less than 45 years
  • Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.
  • Spinal pain numeric rating scale score of more than 4 at Baseline.
  • inadequate response to or failure to respond to at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to randomization

Key Exclusion Criteria:

  • Chest X-ray or MRI with evidence of ongoing infectious or malignant process
  • Patients previously treated with any biological immunomodulating agents, except those targeting tumor necrosis factor alpha.
  • Patients who have been exposed to more than one anti-tumor necrosis factor alpha agent.
  • Active ongoing inflammatory diseases other than axial spondyloarthritis
  • Other ongoing mechanical diseases affecting the spine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Secukinumab 150 mg (Group A)
Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
PLACEBO_COMPARATOR: Placebo (Group B)
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
Drug: AIN457 Placebo
Placebo matching AIN457
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Arm A1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
Drug: AIN457 Placebo
Placebo matching AIN457
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Arm A2
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
Drug: AIN457 Placebo
Placebo matching AIN457
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Arm A3
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
ACTIVE_COMPARATOR: Arm B1
Treatment Period 2: Secukinumab 150 mg (1 x 1.0 mL) plus placebo (1 x 1.0 mL) administered at Week 8, 12, 16 and 20
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab
Drug: AIN457 Placebo
Placebo matching AIN457
Other Names:
  • Placebo
ACTIVE_COMPARATOR: Arm B2
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
Biological: AIN457
anti IL-17a monoclonal antibody
Other Names:
  • secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
Time Frame: Week 8
The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. It is an 11-point scale from 0-10: 1) "0" = no pain. 2) "10" = the most intense pain imaginable. To calculate the average spinal pain, the patient was asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
Time Frame: Week 8
The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2017

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

February 15, 2019

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (ACTUAL)

May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457H3301
  • 2017-000401-21 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is commited 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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