Trial · NCT03066609
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
NCT03066609, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis. Trials, record NCT03066609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03066609
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
- NCT number
- NCT03066609
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 543 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Plaque Psoriasis
- Interventions
- Secukinumab 150 mg s.c., Secukinumab 300 mg s.c., Placebo
- First posted
- 2017-02-28
- Last updated
- 2019-12-30
- Results first posted
- 2019-12-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
| Primary | Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Week 12 | Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. |
| Secondary | Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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 | Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | Week 52 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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 | Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | Week 52 | Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (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. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. |
| Secondary | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | week 1, week 12, week 24, week 52 | Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response |
| Secondary | American Collage of Rheumatology (ACR) Response 20/50/70 | week 12, week 24, week 52 | Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity |
| Secondary | Time to PASI 75 Response up to Week 12 | week 12 | Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Week 12 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Week 12 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Week 12 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | Week 52 | full analysis set with measure | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | Week 52 | full analysis set with measure | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation) | week 1, week 12, week 24, week 52 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | American Collage of Rheumatology (ACR) Response 20/50/70 | week 12, week 24, week 52 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to PASI 75 Response up to Week 12 | week 12 | full analysis set | days | MEDIAN |
Source ClinicalTrials.gov
Results by group151
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Secukinumab 150mg | 112 | Participants | ||
| Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Secukinumab 300mg | 254 | Participants | ||
| Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation) | Placebo | 6 | Participants | ||
| Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Secukinumab 150mg | 92 | Participants | ||
| Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Secukinumab 300mg | 214 | Participants | ||
| Investigator's Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation) | Placebo | 4 | Participants | ||
| Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Secukinumab 150mg | 85 | Participants | ||
| Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Secukinumab 300mg | 210 | Participants | ||
| Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation) | Placebo | 2 | Participants | ||
| Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | Secukinumab 150mg | 94 | Participants |
1 to 10 of 151Source ClinicalTrials.gov
See all 151 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| INDUCTION | STARTED | Secukinumab 150mg | 136 | |
| INDUCTION | STARTED | Secukinumab 300mg | 272 | |
| INDUCTION | STARTED | Placebo | 135 | |
| INDUCTION | STARTED | Placebo - Secukinumab 300mg | 0 | |
| INDUCTION | COMPLETED | Secukinumab 150mg | 134 | |
| INDUCTION | COMPLETED | Secukinumab 300mg | 270 | |
| INDUCTION | COMPLETED | Placebo | 133 | |
| INDUCTION | COMPLETED | Placebo - Secukinumab 300mg | 0 | |
| INDUCTION | NOT COMPLETED | Secukinumab 150mg | 2 | |
| INDUCTION | NOT COMPLETED | Secukinumab 300mg | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events290
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 150 mg | 13 | 136 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 300 mg | 31 | 272 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 300 mg | 42 | 401 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 Dose | 55 | 537 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 12 | 135 | |
| other | Pyrexia | General disorders | AIN457 150 mg | 4 | 136 | |
| other | Pyrexia | General disorders | AIN457 300 mg | 14 | 272 | |
| other | Pyrexia | General disorders | Any AIN457 300 mg | 18 | 401 | |
| other | Pyrexia | General disorders | Any AIN457 Dose | 22 | 537 | |
| other | Pyrexia | General disorders | Placebo | 1 | 135 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 150 mg | 0 | 136 |
| Total, all-cause mortality | AIN457 300 mg | 0 | 272 |
| Total, all-cause mortality | Any AIN457 300 mg | 0 | 401 |
| Total, all-cause mortality | Any AIN457 Dose | 0 | 537 |
| Total, all-cause mortality | Placebo | 0 | 135 |
| Total, other adverse events | AIN457 150 mg | 115 | 136 |
| Total, other adverse events | AIN457 300 mg | 221 | 272 |
| Total, other adverse events | Any AIN457 300 mg | 312 | 401 |
| Total, other adverse events | Any AIN457 Dose | 427 | 537 |
| Total, other adverse events | Placebo | 71 | 135 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33060370 | DERIVED |
Source PubMed
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 |
|---|---|
Secukinumab 150mg vs Secukinumab 300mg: Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation) | Trial comparisons |
| Secukinumab 150mg vs Secukinumab 300mg: Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation) | 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.
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