Trial · NCT01544595
Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
NCT01544595, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2018-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab. Trials, record NCT01544595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01544595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
- NCT number
- NCT01544595
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,147 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Moderate to Severe Plaque-type Psoriasis
- Interventions
- Secukinumab (AIN457), Placebo
- First posted
- 2012-03-06
- Last updated
- 2018-12-20
- Results first posted
- 2018-12-20
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | At week 68 (16 weeks after week 52) | The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52). Loss of PASI 75 response was analyzed by means of a survival analysis defining "loss of PASI 75 response" as "failure". The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t. PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders. |
| Secondary | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab. PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement \[reduction\] in PASI score compared to baseline of the core study). PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders. PASI 100 response/remission: complete clearing of psoriasis (PASI=0) |
| Secondary | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region. |
| Secondary | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | The improvement (decrease from baseline) in PASI total scores observed at Week 52. Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Secondary | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included. |
| Secondary | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Week 52 (baseline), 104, and 156 | Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions). Patients in the placebo groups were not evaluable after re-treatment with Secukinumab |
| Secondary | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) |
| Secondary | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline. |
| Secondary | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | Week 68 | Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52. time = 0 refers to Week 52 |
| Secondary | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | up to week 260 | PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | At week 68 (16 weeks after week 52) | Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment. | Cummulative rate | NUMBER |
| SECONDARY | Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | FAS | Number of participants | NUMBER |
| SECONDARY | Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | FAS | Number of participants | NUMBER |
| SECONDARY | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period | Week 52, 104, and 156 | FAS | Percent change in PASI score | MEAN |
| SECONDARY | Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | FAS | Percent change in PASI score | MEAN |
| SECONDARY | Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period | Week 52 (baseline), 104, and 156 | FAS | Number of participants | NUMBER |
| SECONDARY | Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | FAS | Number of participants | NUMBER |
| SECONDARY | Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period | Week 52, Week 104, Week 156, week 208, week 260 | FAS | Number of participants | NUMBER |
| SECONDARY | Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period | Week 68 | FAS | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse | up to week 260 | FAS | Percent of participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group569
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | AIN457 150 mg -Randomized Withdrawal Period | 49.8 | 95% Confidence Interval 25.8 to 79.7 | Cummulative rate | |
| Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | AIN457 300 mg -Randomized Withdrawal Period | 25.4 | 95% Confidence Interval 9.8 to 56.5 | Cummulative rate | |
| Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | AIN457 150 mg Placebo - Randomized Withdrawal Period | 74.3 | 95% Confidence Interval 56.9 to 88.8 | Cummulative rate | |
| Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68 | AIN457 300 mg Placebo - Randomized Withdrawal Period | 64.7 | 95% Confidence Interval 52.0 to 77.2 | Cummulative rate | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 150 mg -Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 208 | Number of participants | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 300 mg -Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 309 | Number of participants | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 150 mg Placebo - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 112 | Number of participants | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 300 mg Placebo - Randomized Withdrawal Period | Wk 52 - IGA 0/1 | 157 | Number of participants | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 150 mg -Randomized Withdrawal Period | Wk 52 - PASI 50 | 297 | Number of participants | |
| Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period | AIN457 300 mg -Randomized Withdrawal Period | Wk 52 - PASI 50 | 363 | Number of participants |
1 to 10 of 569Source ClinicalTrials.gov
See all 569 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Status at Week 68 | STARTED | AIN457 150 mg -Randomized Withdrawal Period | 301 | |
| Status at Week 68 | STARTED | AIN457 300 mg -Randomized Withdrawal Period | 363 | |
| Status at Week 68 | STARTED | AIN457 150 mg Placebo - Randomized Withdrawal Period | 150 | |
| Status at Week 68 | STARTED | AIN457 300 mg Placebo - Randomized Withdrawal Period | 181 | |
| Status at Week 68 | STARTED | AIN457 150 mg - Partial Responders | 0 | |
| Status at Week 68 | STARTED | AIN457 300 mg - Partial Responders | 0 | |
| Status at Week 68 | COMPLETED | AIN457 150 mg -Randomized Withdrawal Period | 262 | |
| Status at Week 68 | COMPLETED | AIN457 300 mg -Randomized Withdrawal Period | 346 | |
| Status at Week 68 | COMPLETED | AIN457 150 mg Placebo - Randomized Withdrawal Period | 87 | |
| Status at Week 68 | COMPLETED | AIN457 300 mg Placebo - Randomized Withdrawal Period | 130 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,475
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 | Abdominal pain upper | Gastrointestinal disorders | Any AIN457 150 mg | 11 | 545 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Any AIN457 300 mg | 15 | 890 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Any AIN457 Dose | 25 | 1,113 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AIN457 150 mg - Placebo | 2 | 150 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AIN457 300 mg - Placebo | 1 | 181 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 150 mg | 29 | 545 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 300 mg | 53 | 890 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 Dose | 81 | 1,113 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 150 mg - Placebo | 3 | 150 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 300 mg - Placebo | 5 | 181 |
1 to 10 of 1,475Source ClinicalTrials.gov
See all 1,475 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Any AIN457 150 mg | 0 | 545 |
| Total, all-cause mortality | Any AIN457 300 mg | 2 | 890 |
| Total, all-cause mortality | Any AIN457 Dose | 2 | 1,113 |
| Total, all-cause mortality | AIN457 150 mg - Placebo | 0 | 150 |
| Total, all-cause mortality | AIN457 300 mg - Placebo | 0 | 181 |
| Total, other adverse events | Any AIN457 150 mg | 386 | 545 |
| Total, other adverse events | Any AIN457 300 mg | 679 | 890 |
| Total, other adverse events | Any AIN457 Dose | 889 | 1,113 |
| Total, other adverse events | AIN457 150 mg - Placebo | 75 | 150 |
| Total, other adverse events | AIN457 300 mg - Placebo | 86 | 181 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36763857 | 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 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.
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GET https://conductscience.org/api/trials/v1/NCT01544595
GET https://conductscience.org/api/trials/v1/NCT01544595/registered?page=2