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

Novartis

Status and phase: Completed; Phase 3

Conditions: Spondyloarthritis

Treatments: Biological: AIN457; Drug: AIN457 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03136861

CAIN457H3301

2017-000401-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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383 participants in 7 patient groups, including a placebo group

Secukinumab 150 mg (Group A)

Experimental group

Description:

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

Treatment:

Biological: AIN457

Placebo (Group B)

Placebo Comparator group

Description:

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

Treatment:

Drug: AIN457 Placebo

Biological: AIN457

Arm A1

Active Comparator group

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

Treatment:

Drug: AIN457 Placebo

Biological: AIN457

Arm A2

Active Comparator group

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

Treatment:

Drug: AIN457 Placebo

Biological: AIN457

Arm A3

Active Comparator group

Description:

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

Treatment:

Biological: AIN457

Arm B1

Active Comparator group

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

Treatment:

Drug: AIN457 Placebo

Biological: AIN457

Arm B2

Active Comparator group

Description:

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

Treatment:

Biological: AIN457