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

Primary Purpose

Spondyloarthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AIN457

AIN457 Placebo

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, inflammatory back pain, spinal pain, secukinumab, AIN457

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Secukinumab 150 mg (Group A)

Placebo (Group B)

Arm A1

Arm A2

Arm A3

Arm B1

Arm B2

Arm Description

Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03136861

First Posted

April 28, 2017

Last Updated

August 12, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03136861

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 30, 2017 (Actual)

Primary Completion Date

February 15, 2019 (Actual)

Study Completion Date

February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondyloarthritis

Keywords

axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, inflammatory back pain, spinal pain, secukinumab, AIN457

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

383 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab 150 mg (Group A)

Arm Type

Experimental

Arm Description

Treatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4

Arm Title

Placebo (Group B)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm A1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm A2

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm A3

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm B1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm B2

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

AIN457

Other Intervention Name(s)

secukinumab

Intervention Description

anti IL-17a monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

AIN457 Placebo

Other Intervention Name(s)

Placebo

Intervention Description

Placebo matching AIN457

Primary Outcome Measure Information:

Title

Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1)

Description

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)

Description

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1413

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1505

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1750

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Zagreb

State/Province

HRV

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen-Bory

ZIP/Postal Code

30599

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Novartis Investigative Site

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Novartis Investigative Site

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Novartis Investigative Site

City

Kuovola

ZIP/Postal Code

45100

Country

Finland

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

681 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

145 61

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

Novartis Investigative Site

City

Dublin 4

ZIP/Postal Code

D04 T6F

Country

Ireland

Facility Name

Novartis Investigative Site

City

Dublin

ZIP/Postal Code

D03 VX82

Country

Ireland

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37134

Country

Italy

Facility Name

Novartis Investigative Site

City

Liepaja

ZIP/Postal Code

LV 3401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 2164

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Warszawa

State/Province

Mazowian

ZIP/Postal Code

02 495

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85 168

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81 756

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04 305

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-224

Country

Poland

Facility Name

Novartis Investigative Site

City

Irkutsk

ZIP/Postal Code

664046

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426009

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Novartis Investigative Site

City

Elda

State/Province

Alicante

ZIP/Postal Code

03600

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Galdakao

State/Province

Bizkaia

Country

Spain

Facility Name

Novartis Investigative Site

City

Torrelavega

State/Province

Cantabria

ZIP/Postal Code

39300

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46014

Country

Spain

Facility Name

Novartis Investigative Site

City

Plasencia

State/Province

Extremadura

ZIP/Postal Code

10600

Country

Spain

Facility Name

Novartis Investigative Site

City

Lugo

State/Province

Galicia

ZIP/Postal Code

27003

Country

Spain

Facility Name

Novartis Investigative Site

City

Orense

State/Province

Galicia

ZIP/Postal Code

32005

Country

Spain

Facility Name

Novartis Investigative Site

City

Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07198

Country

Spain

Facility Name

Novartis Investigative Site

City

Torrejon de Ardoz

State/Province

Madrid

ZIP/Postal Code

28850

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

State/Province

ZIP/Postal Code

113 65

Country

Sweden

Facility Name

Novartis Investigative Site

City

Danderyd

ZIP/Postal Code

182 88

Country

Sweden

Facility Name

Novartis Investigative Site

City

Halmstad

ZIP/Postal Code

SE 302 66

Country

Sweden

Facility Name

Novartis Investigative Site

City

Harnosand

ZIP/Postal Code

SE 871 31

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Stoke on Trent

State/Province

Staffordshire

ZIP/Postal Code

ST6 7AG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Warrington

ZIP/Postal Code

WA5 1QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

34707696

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.

Results Reference

derived

Links:

URL

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

Description

A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

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

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

Spondyloarthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial