SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
SKIPPAIN
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
2 other identifiers
interventional
383
16 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2017
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedStudy Start
First participant enrolled
June 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedResults Posted
Study results publicly available
February 19, 2020
CompletedSeptember 5, 2021
August 1, 2021
1.6 years
April 28, 2017
February 5, 2020
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1)
Week 8
Study Arms (7)
Secukinumab 150 mg (Group A)
EXPERIMENTALTreatment Period 1: Secukinumab 150 mg (1 x 1.0 mL) s.c. administered at Baseline, Week 1, 2, 3 and 4
Placebo (Group B)
PLACEBO COMPARATORTreatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
Arm A1
ACTIVE COMPARATORTreatment 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 A2
ACTIVE COMPARATORTreatment 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 A3
ACTIVE COMPARATORTreatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
Arm B1
ACTIVE COMPARATORTreatment 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 B2
ACTIVE COMPARATORTreatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
Interventions
anti IL-17a monoclonal antibody
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Novartis Investigative Site
Brussels, 1020, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Burgas, 8000, Bulgaria
Novartis Investigative Site
Plovdiv, 4000, Bulgaria
Novartis Investigative Site
Sofia, 1413, Bulgaria
Novartis Investigative Site
Sofia, 1505, Bulgaria
Novartis Investigative Site
Sofia, 1750, Bulgaria
Novartis Investigative Site
Zagreb, HRV, 10000, Croatia
Novartis Investigative Site
Rijeka, 51000, Croatia
Novartis Investigative Site
Zagreb, 10000, Croatia
Novartis Investigative Site
Brno, 63800, Czechia
Novartis Investigative Site
Plzen-Bory, 30599, Czechia
Novartis Investigative Site
Prague, 150 06, Czechia
Novartis Investigative Site
Pärnu, 80010, Estonia
Novartis Investigative Site
Tallinn, 10138, Estonia
Novartis Investigative Site
Tartu, 50406, Estonia
Novartis Investigative Site
Kuopio, 70100, Finland
Novartis Investigative Site
Kuovola, 45100, Finland
Novartis Investigative Site
Alexandroupoli, Evros, 681 00, Greece
Novartis Investigative Site
Thessaloniki, GR, 564 29, Greece
Novartis Investigative Site
Athens, 115 27, Greece
Novartis Investigative Site
Athens, 145 61, Greece
Novartis Investigative Site
Thessaloniki, 54636, Greece
Novartis Investigative Site
Dublin, D03 VX82, Ireland
Novartis Investigative Site
Dublin, D04 T6F, Ireland
Novartis Investigative Site
Verona, VR, 37134, Italy
Novartis Investigative Site
Liepāja, LV 3401, Latvia
Novartis Investigative Site
Riga, LV 1002, Latvia
Novartis Investigative Site
Riga, LV 2164, Latvia
Novartis Investigative Site
Kaunas, LTU, LT 50161, Lithuania
Novartis Investigative Site
Kaunas, LT, LT-50128, Lithuania
Novartis Investigative Site
Warsaw, Mazowian, 02 495, Poland
Novartis Investigative Site
Bydgoszcz, 85 168, Poland
Novartis Investigative Site
Sopot, 81 756, Poland
Novartis Investigative Site
Torun, 87-100, Poland
Novartis Investigative Site
Warsaw, 00-874, Poland
Novartis Investigative Site
Warsaw, 04 305, Poland
Novartis Investigative Site
Wroclaw, 53-224, Poland
Novartis Investigative Site
Irkutsk, 664046, Russia
Novartis Investigative Site
Izhevsk, 426009, Russia
Novartis Investigative Site
Kazan', 420097, Russia
Novartis Investigative Site
Moscow, 115093, Russia
Novartis Investigative Site
Elche, Alicante, 03203, Spain
Novartis Investigative Site
Elda, Alicante, 03600, Spain
Novartis Investigative Site
Seville, Andalusia, 41009, Spain
Novartis Investigative Site
Seville, Andalusia, 41013, Spain
Novartis Investigative Site
Mallorca, Balearic Islands, 07198, Spain
Novartis Investigative Site
Galdakao, Bizkaia, Spain
Novartis Investigative Site
Torrelavega, Cantabria, 39300, Spain
Novartis Investigative Site
Plasencia, Extremadura, 10600, Spain
Novartis Investigative Site
Lugo, Galicia, 27003, Spain
Novartis Investigative Site
Ourense, Galicia, 32005, Spain
Novartis Investigative Site
Torrejón de Ardoz, Madrid, 28850, Spain
Novartis Investigative Site
Valencia, Valencia, 46010, Spain
Novartis Investigative Site
Valencia, Valencia, 46014, Spain
Novartis Investigative Site
Barcelona, 08041, Spain
Novartis Investigative Site
Stockholm, SE, 113 65, Sweden
Novartis Investigative Site
Danderyd, 182 88, Sweden
Novartis Investigative Site
Halmstad, SE 302 66, Sweden
Novartis Investigative Site
Härnösand, SE 871 31, Sweden
Novartis Investigative Site
Basel, 4031, Switzerland
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom
Novartis Investigative Site
Liverpool, L9 7AL, United Kingdom
Novartis Investigative Site
Plymouth, PL6 8DH, United Kingdom
Novartis Investigative Site
Warrington, WA5 1QG, United Kingdom
Novartis Investigative Site
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 34707696DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 2, 2017
Study Start
June 30, 2017
Primary Completion
February 15, 2019
Study Completion
February 15, 2019
Last Updated
September 5, 2021
Results First Posted
February 19, 2020
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Upon request
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.