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

Spondyloarthritis Clinical Trial

— SKIPPAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136861
• Other study ID #: CAIN457H3301
• Secondary ID: 2017-000401-21
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Biological:
• AIN457
anti IL-17a monoclonal antibody

Drug:
• AIN457 Placebo
Placebo matching AIN457

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Liege
Bulgaria	Novartis Investigative Site	Burgas
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Croatia	Novartis Investigative Site	Rijeka
Croatia	Novartis Investigative Site	Zagreb
Croatia	Novartis Investigative Site	Zagreb	HRV
Czechia	Novartis Investigative Site	Brno
Czechia	Novartis Investigative Site	Plzen-Bory
Czechia	Novartis Investigative Site	Praha 5
Estonia	Novartis Investigative Site	Parnu
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Kuopio
Finland	Novartis Investigative Site	Kuovola
Greece	Novartis Investigative Site	Alexandroupolis	Evros
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki
Greece	Novartis Investigative Site	Thessaloniki	GR
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin 4
Italy	Novartis Investigative Site	Verona	VR
Latvia	Novartis Investigative Site	Liepaja
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas	LT
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Sopot
Poland	Novartis Investigative Site	Torun
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa	Mazowian
Poland	Novartis Investigative Site	Wroclaw
Russian Federation	Novartis Investigative Site	Irkutsk
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Elche	Alicante
Spain	Novartis Investigative Site	Elda	Alicante
Spain	Novartis Investigative Site	Galdakao	Bizkaia
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigative Site	Mallorca	Islas Baleares
Spain	Novartis Investigative Site	Orense	Galicia
Spain	Novartis Investigative Site	Plasencia	Extremadura
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Torrejon de Ardoz	Madrid
Spain	Novartis Investigative Site	Torrelavega	Cantabria
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Sweden	Novartis Investigative Site	Danderyd
Sweden	Novartis Investigative Site	Halmstad
Sweden	Novartis Investigative Site	Harnosand
Sweden	Novartis Investigative Site	Stockholm	SE
Switzerland	Novartis Investigative Site	Basel
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Stoke on Trent	Staffordshire
United Kingdom	Novartis Investigative Site	Warrington
United Kingdom	Novartis Investigative Site	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Croatia,  Czechia,  Estonia,  Finland,  Greece,  Ireland,  Italy,  Latvia,  Lithuania,  Poland,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)	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	Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)	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

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com