Trial · NCT02826603
Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
NCT02826603, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis. Trials, record NCT02826603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02826603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
- NCT number
- NCT02826603
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,114 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Plaque Psoriasis
- Interventions
- Secukinumab, Ustekinumab
- First posted
- 2016-07-11
- Last updated
- 2019-07-09
- Other registries' IDs
- eudract:2015-002898-37
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Week 12 | Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4). |
| Primary | Participants With IGA Mod 2011 0 or 1 at Week 12 | Week 12 | Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease) |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Week 12 | Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline. |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Week 4 | Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline. |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Week 16 | Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline. |
| Secondary | Participants With IGA Mod 2011 0 or 1 at 16 Weeks | Week 16 | Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease) |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 | Week 12 | Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline. |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | Week 16 | Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline. |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Week 16 | Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline. |
| Secondary | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 | Week 52 | Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline. |
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 | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Week 12 | The Full analysis set (FAS) is all patients from the randomized set assigned to study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned at randomization. If the actual randomization stratum was different to the assigned stratum in IRT, the actual stratum was used in the analyses. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With IGA Mod 2011 0 or 1 at Week 12 | Week 12 | The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Week 12 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Week 4 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Week 16 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With IGA Mod 2011 0 or 1 at 16 Weeks | Week 16 | The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 | Week 12 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | Week 16 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Week 16 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 | Week 52 | FAS | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Secukinumab 300mg (2 x 150 mg) | 366 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Ustekinumab 2 x 45mg or 90mg | 265 | Participants | ||
| Participants With IGA Mod 2011 0 or 1 at Week 12 | Secukinumab 300mg (2 x 150 mg) | 397 | Participants | ||
| Participants With IGA Mod 2011 0 or 1 at Week 12 | Ustekinumab 2 x 45mg or 90mg | 306 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Secukinumab 300mg (2 x 150 mg) | 484 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Ustekinumab 2 x 45mg or 90mg | 409 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Secukinumab 300mg (2 x 150 mg) | 221 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Ustekinumab 2 x 45mg or 90mg | 90 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Secukinumab 300mg (2 x 150 mg) | 250 | Participants | ||
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Ustekinumab 2 x 45mg or 90mg | 147 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Secukinumab 300mg (2 x 150 mg) | 550 | |
| Overall Study | STARTED | Ustekinumab 2 x 45mg or 90mg | 552 | |
| Overall Study | COMPLETED | Secukinumab 300mg (2 x 150 mg) | 489 | |
| Overall Study | COMPLETED | Ustekinumab 2 x 45mg or 90mg | 488 | |
| Overall Study | NOT COMPLETED | Secukinumab 300mg (2 x 150 mg) | 61 | |
| Overall Study | NOT COMPLETED | Ustekinumab 2 x 45mg or 90mg | 64 |
Source ClinicalTrials.gov
Adverse events240
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 | AIN457 300 mg | 26 | 550 | |
| other | Diarrhoea | Gastrointestinal disorders | UST 45/90 mg | 24 | 552 | |
| other | Diarrhoea | Gastrointestinal disorders | All Patients | 50 | 1,102 | |
| other | Nausea | Gastrointestinal disorders | AIN457 300 mg | 6 | 550 | |
| other | Nausea | Gastrointestinal disorders | UST 45/90 mg | 13 | 552 | |
| other | Nausea | Gastrointestinal disorders | All Patients | 19 | 1,102 | |
| other | Bronchitis | Infections and infestations | AIN457 300 mg | 8 | 550 | |
| other | Bronchitis | Infections and infestations | UST 45/90 mg | 18 | 552 | |
| other | Bronchitis | Infections and infestations | All Patients | 26 | 1,102 | |
| other | Conjunctivitis | Infections and infestations | AIN457 300 mg | 12 | 550 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 300 mg | 2 | 550 |
| Total, all-cause mortality | UST 45/90 mg | 0 | 552 |
| Total, all-cause mortality | All Patients | 2 | 1,102 |
| Total, other adverse events | AIN457 300 mg | 216 | 550 |
| Total, other adverse events | UST 45/90 mg | 229 | 552 |
| Total, other adverse events | All Patients | 445 | 1,102 |
| Total, serious adverse events | AIN457 300 mg | 29 | 550 |
| Total, serious adverse events | UST 45/90 mg | 21 | 552 |
| Total, serious adverse events | All Patients | 50 | 1,102 |
Source ClinicalTrials.gov
Papers4
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants With IGA Mod 2011 0 or 1 at 16 Weeks | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants With IGA Mod 2011 0 or 1 at Week 12 | Trial comparisons |
| Secukinumab 300mg (2 x 150 mg) vs Ustekinumab 2 x 45mg or 90mg: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 | 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/NCT02826603
GET https://conductscience.org/api/trials/v1/NCT02826603/events?page=2