Clinical trial NCT03136861: SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spondyloarthritis
Keywords: axial spondyloarthritis
ankylosing spondylitis
non-radiographic axial spondyloarthritis
inflammatory back pain
spinal pain
secukinumab
AIN457
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-02
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
timeFrame: Week 8
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Burgas
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Brno
country: Czechia
facility: Novartis Investigative Site
city: Plzen-Bory
country: Czechia
facility: Novartis Investigative Site
city: Praha 5
country: Czechia
facility: Novartis Investigative Site
city: Parnu
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Kuovola
country: Finland
facility: Novartis Investigative Site
city: Alexandroupolis
country: Greece
facility: Novartis Investigative Site
state: Evros
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Liepaja
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Warszawa
country: Poland
facility: Novartis Investigative Site
state: Mazowian
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Torun
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Izhevsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Elda
country: Spain
facility: Novartis Investigative Site
state: Alicante
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Galdakao
country: Spain
facility: Novartis Investigative Site
state: Bizkaia
city: Torrelavega
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Plasencia
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Lugo
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Orense
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Torrejon de Ardoz
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
state: SE
city: Danderyd
country: Sweden
facility: Novartis Investigative Site
city: Halmstad
country: Sweden
facility: Novartis Investigative Site
city: Harnosand
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Stoke on Trent
country: United Kingdom
facility: Novartis Investigative Site
state: Staffordshire
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Warrington
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Poddubnyy D, Pournara E, Zielinska A, Baranauskaite A, Jimenez AM, Sadhu S, Schulz B, Rissler M, Perella C, Marzo-Ortega H. Rapid improvement in spinal pain in patients with axial spondyloarthritis treated with secukinumab: primary results from a randomized controlled phase-IIIb trial. Ther Adv Musculoskelet Dis. 2021 Oct 22;13:1759720X211051471. doi: 10.1177/1759720X211051471. eCollection 2021.