A Phase 3 interventional study of secukinumab 150 mg and secukinumab 300 mg in Moderate to Severe Plaque-type Psoriasis, sponsored by Novartis Pharmaceuticals. Completed at 33 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 177 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
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Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater.
-Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.
Exclusion criteria:
Drug
Drug: secukinumab 150 mg
Drug
Drug: secukinumab 300 mg
Drug: placebo
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.
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
Time frame: 12 weeks
Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12
The IGA 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 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 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
Time frame: 12 weeks
Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time frame: Week 12
Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
Time frame: Baseline, week 48
Number of Subjects With Potential Use Related Hazards at Week 1
To assess potential use-related hazards with the secukinumab PFS for the subject
Time frame: Week 1
Percentage of Subjects With Successful Self Administration of Study Drug at Week 1
To assess the subject's ability to follow instructions for use with the secukinumab PFS
Time frame: Week 1
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation
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.
Time frame: Week 12
Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)
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.
Time frame: Week 52
Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)
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.
Time frame: Week 52
Absolute Change From Baseline for PASI Score at Week 12, (Induction)
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
Time frame: Week 12
Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
Time frame: Week 52
Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)
The IGA mod 2011 category 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
Time frame: Week 12
Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)
The IGA mod 2011 category 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.
Time frame: Week 52
Change From Baseline in EQ-5D at Week 12 (Induction)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Time frame: Week 12
Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
Time frame: Week 52
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time frame: Baseline and week 12
Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
Time frame: Baseline and week 52
Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time frame: Week 12
Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
Time frame: Week 52
Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After 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.
Time frame: Week 172
Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
Time frame: Week 172
Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
Time frame: Week 172
Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment
Time frame: Baseline and at Week 12, 24, 52, 100, 148, and 196, 204
"Study terminated by Sponsor" refers to the fact that - as per protocol - patients had to stop participating in the study in a given country where Secukinumab became available following approval.
| Milestone | AIN457 150 mg | AIN457 300 mg | Placebo - AIN457 150mg | Placebo - AIN457 300mg | Placebo |
|---|---|---|---|---|---|
| Started | 59 | 59 | 0 | 0 | 59 |
| Completed | 58 | 56 | 0 | 0 | 56 |
| Not completed | 1 | 3 | 0 | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Subject / guardian decision | 0 | 0 | 0 | 0 | 2 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 |
| Milestone | AIN457 150 mg | AIN457 300 mg | Placebo - AIN457 150mg | Placebo - AIN457 300mg | Placebo |
|---|---|---|---|---|---|
| Started | 58 | 56 | 29 | 27 | 0 |
| Completed | 48 | 52 | 25 | 25 | 0 |
| Not completed | 10 | 4 | 4 | 2 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Subject / guardian decision | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 6 | 1 | 3 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 1 | 0 |
| Milestone | AIN457 150 mg | AIN457 300 mg | Placebo - AIN457 150mg | Placebo - AIN457 300mg | Placebo |
|---|---|---|---|---|---|
| Started | 46 | 51 | 23 | 23 | 0 |
| Completed | 1 | 0 | 0 | 1 | 0 |
| Not completed | 45 | 51 | 23 | 22 | 0 |
| Withdrew: Adverse event | 1 | 2 | 1 | 1 | 0 |
| Withdrew: Protocol deviation | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 7 | 6 | 3 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 2 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 32 | 33 | 16 | 20 | 0 |
| Withdrew: Subject/guardian decision | 1 | 9 | 1 | 0 | 0 |
| Withdrew: Technical problems | 1 | 0 | 0 | 1 | 0 |
| Milestone | AIN457 150 mg | AIN457 300 mg | Placebo - AIN457 150mg | Placebo - AIN457 300mg | Placebo |
|---|---|---|---|---|---|
| Started | 36 | 31 | 19 | 18 | 0 |
| Completed | 32 | 30 | 18 | 17 | 0 |
| Not completed | 4 | 1 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Subject / guardian decision | 3 | 1 | 1 | 1 | 0 |
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
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response. | 69.5 | 75.9 | 0 |
The IGA 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 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 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
| Percentage of Participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12 | 52.5 | 69 | 0 |
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
| Score | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Feelings about injections | 1.07 ± 1.912 | 0.85 ± 1.685 | 0.57 ± 1.509 |
| Self confidence | 1.10 ± 2.331 | 1.08 ± 2.197 | 1.26 ± 2.009 |
| Satisfaction with self-injection | 1.64 ± 2.163 | 1.62 ± 2.667 | 1.32 ± 2.629 |
The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.
| Score | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo-AIN457 300mg |
|---|---|---|---|---|
| Feelings about injections | 0.93 ± 1.752 | 1.01 ± 2.103 | 0.63 ± 1.449 | 0.76 ± 1.321 |
| Self-confidence | 1.63 ± 3.173 | 1.24 ± 2.400 | 0.97 ± 1.811 | 0.94 ± 1.521 |
| Satisfaction, self-injection | 1.92 ± 2.239 | 2.15 ± 2.673 | 1.90 ± 3.250 | 0.54 ± 1.840 |
To assess potential use-related hazards with the secukinumab PFS for the subject
| Number of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Needle stick in a critical area | 0 | 0 | 0 |
| Needle stick in non-critical area | 0 | 0 | 1 |
| Any part of the device swallowed | 0 | 0 | 0 |
| Allergic reaction to device material | 0 | 0 | 0 |
| Pain due to bent needle | 0 | 0 | 0 |
| Any breakage of the device | 0 | 0 | 0 |
| Swallowing of material debris observed | 0 | 0 | 0 |
| Any other problem | 1 | 0 | 0 |
| Less than full dose administered | 1 | 0 | 0 |
To assess the subject's ability to follow instructions for use with the secukinumab PFS
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Percentage of Subjects With Successful Self Administration of Study Drug at Week 1 | 100 | 100 | 100 |
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.
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Week 12 PASI 50 | 86.4 | 87.9 | 5.1 |
| Week 12 PASI 90 | 45.8 | 60.3 | 0 |
| Week 12 PASI 100 | 8.5 | 43.1 | 0 |
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.
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Week 52 PASI 75 | 71.4 | 84.6 | 72.0 | 96.0 |
| Week 52 PASI 50 | 89.8 | 96.2 | 84.0 | 100.0 |
| Week 52 PASI 90 | 59.2 | 69.2 | 64.0 | 76.0 |
| Week 52 PASI 100 | 36.7 | 48.1 | 52.0 | 44.0 |
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.
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data) | 51 | 71.2 | 72 | 92 |
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
| Units on a scale | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Absolute Change From Baseline for PASI Score at Week 12, (Induction) | -16.33 ± 8.49 | -17.90 ± 8.74 | 0.50 ± 7.22 |
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
| Units on a scale | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data) | -16.9 ± 8.27 | -18.7 ± 8.48 | -15.2 ± 5.38 | -20 ± 7.96 |
The IGA mod 2011 category 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
| Number of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| clear | 6 | 26 | 0 |
| almost clear | 26 | 17 | 0 |
| mild | 12 | 9 | 1 |
| moderate | 14 | 5 | 34 |
| severe | 1 | 1 | 24 |
The IGA mod 2011 category 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.
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Clear | 36.7 | 48.1 | 52 | 44 |
| Almost clear | 14.3 | 23.1 | 20 | 48 |
| Mild | 18.4 | 19.2 | 4 | 4 |
| Moderate | 26.5 | 9.6 | 20 | 4 |
| Severe | 4.1 | 0 | 4 | 0 |
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
| Units on a scale | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Change From Baseline in EQ-5D at Week 12 (Induction) | 12.1 ± 24.03 | 11.2 ± 18.02 | 0.8 ± 16.12 |
ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example "confined to bed") A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)
| Units on a scale | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo-AIN457 300mg |
|---|---|---|---|---|
| Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance) | 11.4 ± 24.79 | 13.5 ± 15.69 | 12.2 ± 15.05 | 19.7 ± 17.16 |
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
| Percent change | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction) | -78.6 (-85.9 to -67.5) | -85.0 (-90.9 to -77.7) | -16.7 (-25.3 to -3.0) |
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference).
| Percent change | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo-AIN457 300mg |
|---|---|---|---|---|
| Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance) | -71.4 (-83.3 to -61.9) | -90.5 (-95.7 to -84.2) | -91.7 (-100 to -81.7) | -97.2 (-100 to -83.3) |
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction) | 54.4 | 54.7 | 7.4 |
The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions
| Percentage of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150 mg | Placebo-AIN457 300mg |
|---|---|---|---|---|
| Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance) | 48.3 | 62.5 | 62.1 | 76.9 |
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.
| Number of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Week 172 PASI 75 | 26 | 25 | 9 | 17 |
| Week 172 PASI 50 | 27 | 32 | 12 | 18 |
| Week 172 PASI 90 | 14 | 21 | 9 | 11 |
| Week 172 PASI 100 | 6 | 16 | 6 | 7 |
PASI: 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:01, arms:0.2 body:0.3 legs:0.4)
| Units on a scale | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Absolute Change From Baseline for PASI Score After Week 52, (Observed Data) | -18 ± 6.97 | -18.7 ± 8.36 | -14.7 ± 5.97 | -19.4 ± 9.02 |
The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe
| Number of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo - AIN457 300 mg |
|---|---|---|---|---|
| Clear | 7 | 15 | 7 | 7 |
| Almost clear | 3 | 4 | 1 | 2 |
| Mild | 16 | 6 | 3 | 6 |
| Moderate | 1 | 7 | 1 | 4 |
| Severe | 0 | 0 | 1 | 0 |
The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment
| Number of participants | AIN457 150 mg | AIN457 300 mg | Placebo-AIN457 150mg | Placebo-AIN457 300mg | Placebo |
|---|---|---|---|---|---|
| Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity | 3 | 0 | 0 | 0 | 0 |
Collected over Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Treatment until Last Patient Last Visit, approximately 4 years.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Induction AIN457 150 mg | — | 1/59 (1.7%) | 29/59 (49.2%) |
| Induction AIN457 300 mg | — | 3/59 (5.1%) | 24/59 (40.7%) |
| Induction Placebo | — | 1/59 (1.7%) | 22/59 (37.3%) |
| Entire Any AIN457 150 mg | — | 10/88 (11.4%) | 70/88 (79.5%) |
| Entire Any AIN457 300 mg | — | 10/86 (11.6%) | 74/86 (86%) |
| Event | Induction AIN457 150 mg | Induction AIN457 300 mg | Induction Placebo | Entire Any AIN457 150 mg | Entire Any AIN457 300 mg |
|---|---|---|---|---|---|
| INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders | 0/59 | 0/59 | 0/59 | 0/88 | 2/86 |
| CELLULITISInfections and infestations | 0/59 | 0/59 | 0/59 | 2/88 | 0/86 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 0/59 | 1/59 | 0/59 | 0/88 | 1/86 |
| CARDIO-RESPIRATORY ARRESTCardiac disorders | 1/59 | 0/59 | 0/59 | 1/88 | 0/86 |
| PNEUMONIAInfections and infestations | 1/59 | 0/59 | 0/59 | 1/88 | 0/86 |
| SEPSISInfections and infestations | 1/59 | 0/59 | 0/59 | 1/88 | 0/86 |
| ADENOSQUAMOUS CELL LUNG CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/59 | 0/59 | 0/59 | 1/88 | 0/86 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 0/59 | 1/59 | 0/59 | 0/88 | 1/86 |
| SCIATICANervous system disorders | 0/59 | 1/59 | 0/59 | 0/88 | 1/86 |
| DERMATITIS EXFOLIATIVESkin and subcutaneous tissue disorders | 0/59 | 0/59 | 1/59 | 0/88 | 0/86 |
| Event | Induction AIN457 150 mg | Induction AIN457 300 mg | Induction Placebo | Entire Any AIN457 150 mg | Entire Any AIN457 300 mg |
|---|---|---|---|---|---|
| NASOPHARYNGITISInfections and infestations | 3/59 | 3/59 | 5/59 | 21/88 | 17/86 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 2/59 | 0/59 | 1/59 | 16/88 | 16/86 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 0/59 | 1/59 | 0/59 | 7/88 | 11/86 |
| OROPHARYNGEAL PAINRespiratory, thoracic and mediastinal disorders | 2/59 | 1/59 | 0/59 | 5/88 | 10/86 |
| DIARRHOEAGastrointestinal disorders | 3/59 | 5/59 | 1/59 | 10/88 | 7/86 |
| TOOTHACHEGastrointestinal disorders | 2/59 | 0/59 | 1/59 | 10/88 | 4/86 |
| COUGHRespiratory, thoracic and mediastinal disorders | 2/59 | 1/59 | 0/59 | 8/88 | 9/86 |
| RHINITISInfections and infestations | 2/59 | 1/59 | 0/59 | 7/88 | 5/86 |
| SINUSITISInfections and infestations | 0/59 | 0/59 | 0/59 | 7/88 | 3/86 |
| VOMITINGGastrointestinal disorders | 0/59 | 2/59 | 0/59 | 4/88 | 6/86 |
| Age, Continuous(Years) | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 46 ± 15.09 | 45.1 ± 12.57 | 46.5 ± 14.14 | 45.9 ± 13.91 |
| Sex: Female, Male(Participants) | AIN457 150 mg | AIN457 300 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 19 | 21 | 20 | 60 |
| Male | 40 | 38 | 39 | 117 |
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Novartis Pharmaceuticals