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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03136861
• Date of registration: 28/04/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis SKIPPAIN
• Scientific 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
• Date of first enrolment: June 30, 2017
• Target sample size: 383
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03136861
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spondyloarthritis

Intervention(s)

Biological: AIN457

Drug: AIN457 Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CAIN457H3301

2017-000401-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03136861