Trial · NCT01358578
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
NCT01358578, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis. Trials, record NCT01358578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358578
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
- NCT number
- NCT01358578
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,306 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Placebo, secukinumab (AIN457), etanercept
- First posted
- 2011-05-23
- Last updated
- 2021-01-05
- Results first posted
- 2015-09-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 12 wks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis |
| Primary | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. |
| Secondary | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 12 wks | A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis |
| Secondary | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 12 wks | A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis |
| Secondary | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. |
| Secondary | Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 52 wks | |
| Secondary | Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 52 wks | |
| Secondary | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | baseline to week 12 | The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy |
| Secondary | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | baseline to week 12 | The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy |
| Secondary | Number of Participants Developing Anti-secukinumab Antibodies | 60 weeks | Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | 12 wks | participants achieving goal | NUMBER | |
| PRIMARY | Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | participants acheiving goal | NUMBER | |
| SECONDARY | Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | 12 wks | FAS | participant who acheived goal | NUMBER |
| SECONDARY | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12 | 12 wks | FAS | participant who acheived goal | NUMBER |
| SECONDARY | Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | 12 wks | FAS | participant acheiving goal | NUMBER |
| SECONDARY | Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation) | 52 wks | Full analysis set | participants who reached goal | NUMBER |
| SECONDARY | Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment | 52 wks | Full analysis set | participants who reached goal | NUMBER |
| SECONDARY | Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo | baseline to week 12 | Full analysis set | units on scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept | baseline to week 12 | Full analysis set | Units on a scale | MEAN |
| SECONDARY | Number of Participants Developing Anti-secukinumab Antibodies | 60 weeks | Full Analysis Set | # participants tested positive | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | AIN457 150mg | 219 | participants achieving goal | ||
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | AIN457 300mg | 249 | participants achieving goal | ||
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . | Placebo | 16 | participants achieving goal | ||
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | AIN457 150mg | 167 | participants acheiving goal | ||
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | AIN457 300mg | 202 | participants acheiving goal | ||
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 | Placebo | 9 | participants acheiving goal | ||
| Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | AIN457 150mg | 137 | participant who acheived goal | ||
| Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | AIN457 300mg | 175 | participant who acheived goal | ||
| Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | Etanercept | 67 | participant who acheived goal | ||
| Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12 | Placebo | 5 | participant who acheived goal |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | AIN457 150mg | 327 | |
| Induction Period | STARTED | AIN457 300mg | 327 | |
| Induction Period | STARTED | Placebo | 326 | |
| Induction Period | STARTED | Etanercept | 326 | |
| Induction Period | STARTED | AIN457 150mg From Placebo | 0 | |
| Induction Period | STARTED | AIN457 300mg From Placebo | 0 | |
| Induction Period | COMPLETED | AIN457 150mg | 315 | |
| Induction Period | COMPLETED | AIN457 300mg | 312 | |
| Induction Period | COMPLETED | Placebo | 301 | |
| Induction Period | COMPLETED | Etanercept | 305 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events2,072
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 | CONJUNCTIVITIS | Eye disorders | INDUCTION-AIN457 150mg | 0 | 327 | |
| other | CONJUNCTIVITIS | Eye disorders | INDUCTION-AIN457 300mg | 3 | 326 | |
| other | CONJUNCTIVITIS | Eye disorders | INDUCTION-Placebo | 1 | 327 | |
| other | CONJUNCTIVITIS | Eye disorders | INDUCTION-Etanercept | 0 | 323 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-AIN457 150mg | 3 | 327 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-AIN457 300mg | 9 | 326 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-Any AIN457 150mg | 3 | 469 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-Any AIN457 300mg | 10 | 467 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-Placebo | 1 | 327 | |
| other | CONJUNCTIVITIS | Eye disorders | ENTIRE-Etanercept | 3 | 323 |
1 to 10 of 2,072Source ClinicalTrials.gov
See all 2,072 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INDUCTION-AIN457 150mg | ||
| Total, all-cause mortality | INDUCTION-AIN457 300mg | ||
| Total, all-cause mortality | INDUCTION-Placebo | ||
| Total, all-cause mortality | INDUCTION-Etanercept | ||
| Total, all-cause mortality | ENTIRE-AIN457 150mg | ||
| Total, all-cause mortality | ENTIRE-AIN457 300mg | ||
| Total, all-cause mortality | ENTIRE-Any AIN457 150mg | ||
| Total, all-cause mortality | ENTIRE-Any AIN457 300mg | ||
| Total, all-cause mortality | ENTIRE-Placebo | ||
| Total, all-cause mortality | ENTIRE-Etanercept |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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