Trial · NCT02409667
Plaque Psoriasis Efficacy and Safety With Secukinumab
NCT02409667, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Plaque Psoriasis Efficacy and Safety With Secukinumab. Trials, record NCT02409667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02409667
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Plaque Psoriasis Efficacy and Safety With Secukinumab
- NCT number
- NCT02409667
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16,487 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Plaque Psoriasis
- Interventions
- Secukinumab
- First posted
- 2015-04-07
- Last updated
- 2019-05-13
- Results first posted
- 2019-05-13
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 | Week 52 | 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). |
| Secondary | Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Week 52 | 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). |
| Secondary | PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | week 52 | 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 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Secondary | PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Week 52 | 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 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. |
| Secondary | Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24 | Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52 | 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). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52 | 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). A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24 | Baseline, Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement. |
| Secondary | Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Week 52 | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement. |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24 | Baseline, Week 52 | The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Week 52 | The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 | Week 52 | Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Week 52 | FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | week 52 | Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Week 52 | Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24 | Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52 | Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52 | Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24 | Baseline, Week 52 | Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Week 52 | Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24 | Baseline, Week 52 | Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24 | Baseline, Week 52 | Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24. | score on a scale | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 1 | 552 | Participants | ||
| Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 2 | 496 | Participants | ||
| Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Treatment Period 2: Group 3 | 53 | Participants | ||
| Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Treatment Period 2: Group 4 | 52 | Participants | ||
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 1 | PASI 50 | 608 | Participants | |
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 2 | PASI 50 | 624 | Participants | |
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 1 | PASI 75 | 597 | Participants | |
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 2 | PASI 75 | 588 | Participants | |
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 1 | PASI 90 | 553 | Participants | |
| PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24 | Treatment Period 2: Group 2 | PASI 90 | 496 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1, Baseline to Week 24 | STARTED | Treatment Period 1: All Participants | 1,647 | |
| Treatment Period 1, Baseline to Week 24 | STARTED | Treatment Period 2: Group 1 | 0 | |
| Treatment Period 1, Baseline to Week 24 | STARTED | Treatment Period 2: Group 2 | 0 | |
| Treatment Period 1, Baseline to Week 24 | STARTED | Treatment Period 2: Group 3 | 0 | |
| Treatment Period 1, Baseline to Week 24 | STARTED | Treatment Period 2: Group 4 | 0 | |
| Treatment Period 1, Baseline to Week 24 | COMPLETED | Treatment Period 1: All Participants | 1,526 | |
| Treatment Period 1, Baseline to Week 24 | COMPLETED | Treatment Period 2: Group 1 | 0 | |
| Treatment Period 1, Baseline to Week 24 | COMPLETED | Treatment Period 2: Group 2 | 0 | |
| Treatment Period 1, Baseline to Week 24 | COMPLETED | Treatment Period 2: Group 3 | 0 | |
| Treatment Period 1, Baseline to Week 24 | COMPLETED | Treatment Period 2: Group 4 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events800
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 | Vertigo | Ear and labyrinth disorders | Treatment Period 1: All Participants | 4 | 1,647 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period 2: Group 1 | 2 | 644 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period 2: Group 2 | 2 | 662 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period 2: Group 3 | 1 | 114 | |
| other | Vertigo | Ear and labyrinth disorders | Treatment Period 2: Group 4 | 2 | 93 | |
| other | Conjunctivitis allergic | Eye disorders | Treatment Period 1: All Participants | 6 | 1,647 | |
| other | Conjunctivitis allergic | Eye disorders | Treatment Period 2: Group 1 | 3 | 644 | |
| other | Conjunctivitis allergic | Eye disorders | Treatment Period 2: Group 2 | 0 | 662 | |
| other | Conjunctivitis allergic | Eye disorders | Treatment Period 2: Group 3 | 1 | 114 | |
| other | Conjunctivitis allergic | Eye disorders | Treatment Period 2: Group 4 | 2 | 93 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Period 1: All Participants | 1 | 1,647 |
| Total, all-cause mortality | Treatment Period 2: Group 1 | 0 | 644 |
| Total, all-cause mortality | Treatment Period 2: Group 2 | 0 | 662 |
| Total, all-cause mortality | Treatment Period 2: Group 3 | 0 | 114 |
| Total, all-cause mortality | Treatment Period 2: Group 4 | 0 | 93 |
| Total, other adverse events | Treatment Period 1: All Participants | 884 | 1,647 |
| Total, other adverse events | Treatment Period 2: Group 1 | 272 | 644 |
| Total, other adverse events | Treatment Period 2: Group 2 | 288 | 662 |
| Total, other adverse events | Treatment Period 2: Group 3 | 64 | 114 |
| Total, other adverse events | Treatment Period 2: Group 4 | 60 | 93 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Treatment Period 2: Group 3 vs Treatment Period 2: Group 4: Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24 | Trial comparisons |
| Treatment Period 2: Group 1 vs Treatment Period 2: Group 2: Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24 | 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.
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GET https://conductscience.org/api/trials/v1/NCT02409667/results?page=2