SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis (SKIPPAIN)
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| ClinicalTrials.gov Identifier: NCT03136861 |
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Recruitment Status :
Completed
First Posted : May 2, 2017
Results First Posted : February 19, 2020
Last Update Posted : September 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spondyloarthritis | Biological: AIN457 Drug: AIN457 Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 383 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 30, 2017 |
| Actual Primary Completion Date : | February 15, 2019 |
| Actual Study Completion Date : | February 15, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab |
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Placebo Comparator: Placebo (Group B)
Treatment Period 1: Placebo (1 x 1.0 mL) s.c. administered at Baseline and Week 1, 2, 3 and 4
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Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab Drug: AIN457 Placebo Placebo matching AIN457
Other Name: Placebo |
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Active Comparator: 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
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Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab Drug: AIN457 Placebo Placebo matching AIN457
Other Name: Placebo |
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Active Comparator: 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
|
Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab Drug: AIN457 Placebo Placebo matching AIN457
Other Name: Placebo |
|
Active Comparator: Arm A3
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab |
|
Active Comparator: 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
|
Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab Drug: AIN457 Placebo Placebo matching AIN457
Other Name: Placebo |
|
Active Comparator: Arm B2
Treatment Period 2: Secukinumab 300 mg (2 x 1.0 mL) administered at Week 8, 12, 16, and 20
|
Biological: AIN457
anti IL-17a monoclonal antibody
Other Name: secukinumab |
- Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8 (Treatment Period 1) [ Time Frame: Week 8 ]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.
- Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8 (Treatment Period 1) [ Time Frame: Week 8 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136861
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03136861 |
| Other Study ID Numbers: |
CAIN457H3301 2017-000401-21 ( EudraCT Number ) |
| First Posted: | May 2, 2017 Key Record Dates |
| Results First Posted: | February 19, 2020 |
| Last Update Posted: | September 5, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Time Frame: | Upon request |
| URL: | https://www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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axial spondyloarthritis ankylosing spondylitis non-radiographic axial spondyloarthritis inflammatory back pain |
spinal pain secukinumab AIN457 |
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Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Musculoskeletal Diseases |
Arthritis Joint Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |