Trial · NCT04156620
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
NCT04156620, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA. Trials, record NCT04156620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04156620
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
- NCT number
- NCT04156620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 527 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Ankylosing Spondylitis
- Interventions
- Secukinumab, Placebo
- First posted
- 2019-11-07
- Last updated
- 2024-06-18
- Results first posted
- 2024-01-23
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria) | Baseline to Week 16 | ASAS40 is ≥ 40% and an absolute improvement from baseline of ≥20 units (range 0-100) in ≥ 3 of the following 4 domains: back pain \[10 cm visual analogue scale (VAS)\], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0-100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement | Baseline to Week 16 | ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L. Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease activity; and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores are a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement" . |
| Secondary | The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline to Week 16 | BASDAI consists of a 0 through 10 scale (0 indicating no problem and 10 indicating the worst problem, captured as a continuous VAS), which was used to answer six questions pertaining to the five major symptoms of AS: fatigue, spinal pain, peripheral joint pain / swelling,, areas of localized tenderness (enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, morning stiffness severity. To give each symptom equal weight, the mean of the two scores relating to morning stiffness is taken into account (questions 5 and 6). The resulting 0 to 10 score is added to the scores for questions 1 through 4. The resulting 0 to 50 score is divided by 5 to give a final 0 10 BASDAI score. |
| Secondary | Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria) | Baseline to Week 16 | The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity. ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). |
| Secondary | The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline to Week 16 | The BASFI is a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The questions were chosen on the basis of predominant input from subjects with AS. The first eight questions consider activities related to functional anatomy. The final two questions assess the subjects' ability to cope with everyday life. A 0-10 scale (captured as a continuous VAS) is used to answer the questions. The BASFI score is the mean of the ten scales - a value between 0 and 10. |
| Secondary | The Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) | Baseline to Week 16 | The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement. |
| Secondary | The Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQol) | Baseline to Week 16 | The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult subjects with AS. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response, resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower scores indicate better quality of life. Items include an assessment of mobility/energy, self care and mood/emotion. The recall period is "at the moment". |
| Secondary | The Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline to Week 16 | This assessment (laboratory assessment) was performed in order to identify the presence of inflammation, to determine its severity and to monitor the response to treatment. Exponentially transformed LSM, the geometric mean ratio of post-baseline/baseline. A value \<1 indicates a reduced CRP |
| Secondary | Percentage of Participants Who Achieved an ASAS20 (Assessment of SpondyloArthritis International Society Criteria) | Baseline to Week 16 | The ASAS Response Criteria (ASAS20) is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the BAS Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the BAS Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). |
| Secondary | The Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease. | Baseline to Week 16 | ASDAS-CRP was utilized to assess disease activity status. Parameters used for the ASDAS included: total back pain (BASDAI question 2), patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and CRP in mg/L. Disease activity states: inactive disease, moderate disease activity, high disease activity, and very high disease activity. The three values selected to separate these states are: \< 1.3 between inactive disease and moderate disease activity; \< 2.1 between moderate disease activity and high disease activity; and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores are a change of ≥ 1.1 unit for "minimal clinically important improvement" and a change of ≥ 2.0 units for "major improvement" |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria) | Baseline to Week 16 | Full analysis set with missing responses for any reason imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement | Baseline to Week 16 | Full analysis set with missing responses for any reason imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline to Week 16 | Full analysis set | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria) | Baseline to Week 16 | Full analysis set with missing responses for any reason imputed as non-responders. | Percentage of participaants | NUMBER |
| SECONDARY | The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) | Baseline to Week 16 | Full analysis set | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) | Baseline to Week 16 | Full analysis set | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQol) | Baseline to Week 16 | Full analysis set | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) | Baseline to Week 16 | Full analysis set | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an ASAS20 (Assessment of SpondyloArthritis International Society Criteria) | Baseline to Week 16 | Full analysis set with missing responses for any reason imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | The Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease. | Baseline to Week 16 | Full analysis set with missing responses for any reason imputed as non-responders. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria) | AIN457 6 mg/kg - 3 mg/kg i.v. | 40.85 | 95% Confidence Interval 34.94 to 46.76 | percentage of participants | |
| Percentage of Participants Who Achieved an ASAS40 (Assessment of SpondyloArthritis International Society Criteria) | Placebo - AIN457 3 mg/kg i.v. | 22.94 | 95% Confidence Interval 17.86 to 28.02 | percentage of participants | |
| Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement | AIN457 6 mg/kg - 3 mg/kg i.v. | 27.99 | 95% Confidence Interval 22.86 to 33.12 | percentage of participants | |
| Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Major Improvement | Placebo - AIN457 3 mg/kg i.v. | 7.54 | 95% Confidence Interval 4.44 to 10.64 | percentage of participants | |
| The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | AIN457 6 mg/kg - 3 mg/kg i.v. | -2.70 | Standard Error 0.144 | scores on a scale | |
| The Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Placebo - AIN457 3 mg/kg i.v. | -1.69 | Standard Error 0.144 | scores on a scale | |
| Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria) | AIN457 6 mg/kg - 3 mg/kg i.v. | 43.92 | 95% Confidence Interval 37.94 to 49.90 | Percentage of participaants | |
| Percentage of Participants Who Achieved an ASAS 5/6 (Assessment of Spondylarthritis International Society Criteria) | Placebo - AIN457 3 mg/kg i.v. | 21.77 | 95% Confidence Interval 16.77 to 26.77 | Percentage of participaants | |
| The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) | AIN457 6 mg/kg - 3 mg/kg i.v. | -2.33 | Standard Error 0.147 | scores on a scale | |
| The Change From Baseline in Total Bath Ankylosing Spondylitis Functional Index (BASFI) | Placebo - AIN457 3 mg/kg i.v. | -1.39 | Standard Error 0.148 | scores on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 6 mg/kg - 3 mg/kg i.v. | 264 | |
| Overall Study | STARTED | Placebo - AIN457 3 mg/kg i.v. | 262 | |
| Overall Study | Completed Period 1 | AIN457 6 mg/kg - 3 mg/kg i.v. | 255 | |
| Overall Study | Completed Period 1 | Placebo - AIN457 3 mg/kg i.v. | 253 | |
| Overall Study | Started Period 2 | AIN457 6 mg/kg - 3 mg/kg i.v. | 255 | |
| Overall Study | Started Period 2 | Placebo - AIN457 3 mg/kg i.v. | 251 | |
| Overall Study | Completed Period 2 | AIN457 6 mg/kg - 3 mg/kg i.v. | 233 | |
| Overall Study | Completed Period 2 | Placebo - AIN457 3 mg/kg i.v. | 235 | |
| Overall Study | COMPLETED | AIN457 6 mg/kg - 3 mg/kg i.v. | 227 | |
| Overall Study | COMPLETED | Placebo - AIN457 3 mg/kg i.v. | 233 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 | 18 | 517 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Until Week 16 | 5 | 261 | |
| other | Nausea | Gastrointestinal disorders | Any AIN457 | 12 | 517 | |
| other | Nausea | Gastrointestinal disorders | Placebo Until Week 16 | 2 | 261 | |
| other | COVID-19 | Infections and infestations | Any AIN457 | 65 | 517 | |
| other | COVID-19 | Infections and infestations | Placebo Until Week 16 | 10 | 261 | |
| other | Nasopharyngitis | Infections and infestations | Any AIN457 | 32 | 517 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Until Week 16 | 7 | 261 | |
| other | Pharyngitis | Infections and infestations | Any AIN457 | 13 | 517 | |
| other | Pharyngitis | Infections and infestations | Placebo Until Week 16 | 1 | 261 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Any AIN457 | 1 | 517 |
| Total, all-cause mortality | Placebo Until Week 16 | 0 | 261 |
| Total, other adverse events | Any AIN457 | 172 | 517 |
| Total, other adverse events | Placebo Until Week 16 | 35 | 261 |
| Total, serious adverse events | Any AIN457 | 32 | 517 |
| Total, serious adverse events | Placebo Until Week 16 | 3 | 261 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Any AIN457 vs Placebo Until Week 16: deaths from any cause | Trial comparisons |
| Any AIN457 vs Placebo Until Week 16: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04156620
GET https://conductscience.org/api/trials/v1/NCT04156620/results?page=2