Trial · NCT02074982
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
NCT02074982, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis. Trials, record NCT02074982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02074982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
- NCT number
- NCT02074982
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 676 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Plaque Type Psoriasis
- Interventions
- AIN457 300 mg, ustekinumab 45/90 mg, placebo secukinumab
- First posted
- 2014-03-03
- Last updated
- 2017-07-21
- Other registries' IDs
- eudract:2013-003434-32
- Results first posted
- 2017-07-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Week 16 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16 |
| Secondary | Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Week 4 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4 |
| Secondary | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Week 52 | Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Week 16 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | Percentage of Participants | NUMBER |
| SECONDARY | Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Week 4 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Week 52 | Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | AIN457 300 mg | 79.0 | Percentage of Participants | ||
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 | Ustekinumab | 57.3 | Percentage of Participants | ||
| Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | AIN457 300 mg | 49.7 | percentage of participants | ||
| Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4 | Ustekinumab | 20.6 | percentage of participants | ||
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | AIN457 300 mg | 74.9 | percentage of participants | ||
| Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52 | Ustekinumab | 60.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 300 mg | 337 | |
| Overall Study | STARTED | Ustekinumab | 339 | |
| Overall Study | Full Analysis Set (FAS) | AIN457 300 mg | 336 | |
| Overall Study | Full Analysis Set (FAS) | Ustekinumab | 339 | |
| Overall Study | Safety Set (SF) | AIN457 300 mg | 335 | |
| Overall Study | Safety Set (SF) | Ustekinumab | 336 | |
| Overall Study | COMPLETED | AIN457 300 mg | 286 | |
| Overall Study | COMPLETED | Ustekinumab | 285 | |
| Overall Study | NOT COMPLETED | AIN457 300 mg | 51 | |
| Overall Study | NOT COMPLETED | Ustekinumab | 54 |
Source ClinicalTrials.gov
Adverse events302
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 | ABDOMINAL PAIN | Gastrointestinal disorders | AIN457 300 mg | 7 | 335 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Ustekinumab | 10 | 336 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | AIN457 300 mg | 12 | 335 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Ustekinumab | 6 | 336 | |
| other | DIARRHOEA | Gastrointestinal disorders | AIN457 300 mg | 22 | 335 | |
| other | DIARRHOEA | Gastrointestinal disorders | Ustekinumab | 24 | 336 | |
| other | DYSPEPSIA | Gastrointestinal disorders | AIN457 300 mg | 10 | 335 | |
| other | DYSPEPSIA | Gastrointestinal disorders | Ustekinumab | 9 | 336 | |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | AIN457 300 mg | 7 | 335 | |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Ustekinumab | 3 | 336 |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 300 mg | ||
| Total, all-cause mortality | Ustekinumab | ||
| Total, other adverse events | AIN457 300 mg | 270 | 335 |
| Total, other adverse events | Ustekinumab | 246 | 336 |
| Total, serious adverse events | AIN457 300 mg | 41 | 335 |
| Total, serious adverse events | Ustekinumab | 32 | 336 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AIN457 300 mg vs Ustekinumab: serious adverse events |
Source 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/NCT02074982
GET https://conductscience.org/api/trials/v1/NCT02074982/events?page=2