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

NCT ID: NCT03136861

Last Updated: 2021-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

383 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2019-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

Placebo (Group B)

Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4

Group Type PLACEBO_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

AIN457 Placebo

Intervention Type DRUG

Placebo matching AIN457

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

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

AIN457 Placebo

Intervention Type DRUG

Placebo matching AIN457

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

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

AIN457 Placebo

Intervention Type DRUG

Placebo matching AIN457

Arm A3

Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

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

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

AIN457 Placebo

Intervention Type DRUG

Placebo matching AIN457

Arm B2

Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20

Group Type ACTIVE_COMPARATOR

AIN457

Intervention Type BIOLOGICAL

anti IL-17a monoclonal antibody

Interventions

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AIN457

anti IL-17a monoclonal antibody

Intervention Type BIOLOGICAL

AIN457 Placebo

Placebo matching AIN457

Intervention Type DRUG

Other Intervention Names

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secukinumab Placebo

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Liège, , Belgium

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Novartis Investigative Site

Burgas, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Zagreb, HRV, Croatia

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Rijeka, , Croatia

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Zagreb, , Croatia

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Brno, , Czechia

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Plzen-Bory, , Czechia

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Prague, , Czechia

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Kuopio, , Finland

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Kuovola, , Finland

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Alexandroupoli, Evros, Greece

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Thessaloniki, GR, Greece

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Athens, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Dublin, , Ireland

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Dublin, , Ireland

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Verona, VR, Italy

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, LTU, Lithuania

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Kaunas, LT, Lithuania

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Warsaw, Mazowian, Poland

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Bydgoszcz, , Poland

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Sopot, , Poland

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Torun, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Irkutsk, , Russia

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Izhevsk, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Elche, Alicante, Spain

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Elda, Alicante, Spain

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Seville, Andalusia, Spain

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Seville, Andalusia, Spain

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Mallorca, Balearic Islands, Spain

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Galdakao, Bizkaia, Spain

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Torrelavega, Cantabria, Spain

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Plasencia, Extremadura, Spain

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Lugo, Galicia, Spain

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Ourense, Galicia, Spain

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Torrejón de Ardoz, Madrid, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Barcelona, , Spain

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Novartis Investigative Site

Stockholm, SE, Sweden

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Novartis Investigative Site

Danderyd, , Sweden

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Novartis Investigative Site

Halmstad, , Sweden

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Novartis Investigative Site

Härnösand, , Sweden

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Novartis Investigative Site

Basel, , Switzerland

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Novartis Investigative Site

Stoke-on-Trent, Staffordshire, United Kingdom

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Novartis Investigative Site

Liverpool, , United Kingdom

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Novartis Investigative Site

Plymouth, , United Kingdom

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Novartis Investigative Site

Warrington, , United Kingdom

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Novartis Investigative Site

Wolverhampton, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 34707696 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=550

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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2017-000401-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457H3301

Identifier Type: -

Identifier Source: org_study_id

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