Trial · NCT01406938
Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
NCT01406938, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-05-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens. Trials, record NCT01406938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01406938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens
- NCT number
- NCT01406938
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 967 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Interventions
- AIN457 150mg, AIN457 300mg
- First posted
- 2011-08-01
- Last updated
- 2015-05-19
- Other registries' IDs
- eudract:2011-000767-27
- Results first posted
- 2015-05-19
- Limitations and caveats
- A limitation of this study is the lack of a placebo group; however, because the placebo response is very low in psoriasis, it is inappropriate to maintain patients on placebo for 52 weeks. .
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | Week 40 , week 52 | 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: 0.1, arms: 0.2 body: 0.3 legs: 0.4) |
| Secondary | Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | Baseline, week 2, 3 , 4, 8, 12 | 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) |
| Secondary | Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52 | Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52 | 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) |
| Secondary | Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction) | Baseline, week 2, 4, 6, 8, 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, 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 | Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period)) | Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52 | 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 |
| Secondary | Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction) | Baseline to week 2, 4, 8, 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) |
| Secondary | Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance) | Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. | 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) |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction) | Baseline to week 2, 4, 8, 12 | 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 |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance) | Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. | 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 |
| Secondary | % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction) | Baseline to week 2, 4, 6, 8, 12 | 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | Week 40 , week 52 | Full analysis set (FAS) - All patients to whom study treatment was assigned. | Percent of participants | NUMBER |
| SECONDARY | Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | Baseline, week 2, 3 , 4, 8, 12 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52 | Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction) | Baseline, week 2, 4, 6, 8, 12 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Percent of participant | NUMBER |
| SECONDARY | Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period)) | Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Percent of participants | NUMBER |
| SECONDARY | Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction) | Baseline to week 2, 4, 8, 12 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance) | Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction) | Baseline to week 2, 4, 8, 12 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance) | Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52. | Full analysis set (FAS) - All patients to whom study treatment was assigned | Units on a scale | MEAN |
| SECONDARY | % of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction) | Baseline to week 2, 4, 6, 8, 12 | Full analysis set (FAS) - All patients to whom study treatment was assigned | Percent of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group748
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | AIN457 150 mg - Fixed Interval (FI) | 62.1 | Percent of participants | ||
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | AIN457 300 mg FI | 78.2 | Percent of participants | ||
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | AIN457 150 mg- Start of Relapse (SoR) | 52.4 | Percent of participants | ||
For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52 | AIN457 300 mg- SoR | 67.7 | Percent of participants | ||
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457150 mg- Induction Period Only(IPO) | Week 2 | -7.46 | Standard Deviation 6.338 | Units on a scale |
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457 300 mg - IPO | Week 2 | -9.28 | Standard Deviation 6.752 | Units on a scale |
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457150 mg- Induction Period Only(IPO) | Week 3 | -11.13 | Standard Deviation 7.826 | Units on a scale |
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457 300 mg - IPO | Week 3 | -12.97 | Standard Deviation 7.826 | Units on a scale |
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457150 mg- Induction Period Only(IPO) | Week 4 | -14.18 | Standard Deviation 8.956 | Units on a scale |
| Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12 | AIN457 300 mg - IPO | Week 4 | -15.90 | Standard Deviation 8.838 | Units on a scale |
1 to 10 of 748Source ClinicalTrials.gov
See all 748 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | AIN457150 mg- Induction Period Only(IPO) | 482 | |
| Induction Period | STARTED | AIN457 300 mg - IPO | 484 | |
| Induction Period | STARTED | AIN457 150 mg - Fixed Interval (FI) | 0 | |
| Induction Period | STARTED | AIN457 300 mg FI | 0 | |
| Induction Period | STARTED | AIN457 150 mg- Start of Relapse (SoR) | 0 | |
| Induction Period | STARTED | AIN457 300 mg- SoR | 0 | |
| Induction Period | FAS:Patients Assigned Study Treatment | AIN457150 mg- Induction Period Only(IPO) | 482 | |
| Induction Period | FAS:Patients Assigned Study Treatment | AIN457 300 mg - IPO | 483 | |
| Induction Period | FAS:Patients Assigned Study Treatment | AIN457 150 mg - Fixed Interval (FI) | 0 | |
| Induction Period | FAS:Patients Assigned Study Treatment | AIN457 300 mg FI | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events2,076
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 | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | INDUCTION-AIN457 150mg | 0 | 482 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | INDUCTION-AIN457 300mg | 0 | 484 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | ENTIRE-AIN457 150mg | 1 | 203 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | ENTIRE-AIN457 300mg | 0 | 217 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | ENTIRE-AIN457 150 mg SoR | 0 | 205 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | ENTIRE-AIN457 300 mg SoR | 0 | 217 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | FOLLOW UP-AIN457 150mg IPO | 0 | 27 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | FOLLOW UP-AIN457 300mg IPO | 0 | 23 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | FOLLOW UP-AIN457 150 mg | 0 | 40 | |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | FOLLOW UP-AIN457 300 mg | 0 | 39 |
1 to 10 of 2,076Source ClinicalTrials.gov
See all 2,076 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | INDUCTION-AIN457 150mg | ||
| Total, all-cause mortality | INDUCTION-AIN457 300mg | ||
| Total, all-cause mortality | ENTIRE-AIN457 150mg | ||
| Total, all-cause mortality | ENTIRE-AIN457 300mg | ||
| Total, all-cause mortality | ENTIRE-AIN457 150 mg SoR | ||
| Total, all-cause mortality | ENTIRE-AIN457 300 mg SoR | ||
| Total, all-cause mortality | FOLLOW UP-AIN457 150mg IPO | ||
| Total, all-cause mortality | FOLLOW UP-AIN457 300mg IPO | ||
| Total, all-cause mortality | FOLLOW UP-AIN457 150 mg | ||
| Total, all-cause mortality | FOLLOW UP-AIN457 300 mg |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01406938
GET https://conductscience.org/api/trials/v1/NCT01406938/results?page=2