Trial · NCT01952015
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
NCT01952015, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP). Trials, record NCT01952015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01952015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
- NCT number
- NCT01952015
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Psoriasis
- Interventions
- Secukinumab
- First posted
- 2013-09-27
- Last updated
- 2019-03-15
- Results first posted
- 2019-03-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | 16 weeks | Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder. |
| Secondary | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | 52 weeks | Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved". Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success". |
| Secondary | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | week 148 | Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved". |
| Secondary | Summary of Clinical Global Impression up to End of Trial | up to week 148 (End of Trial) | Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened. Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success". |
| Secondary | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | up to week 148 (End of Trial) | Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index. |
| Secondary | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | up to week 148 (end of trial) | The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin. The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2. The higher the JDA severity index for GPP score the worse the outcome. |
| Secondary | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | up to week 148 (end of trial) | The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL). Percent change=100 x Absolute change/post baseline. |
| Secondary | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | Up to week 148 (end of treatment) | DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay \& Khan 94). The measure is self-admin. \& includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute \& chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life. |
| Secondary | Number of Patients With GPP-related Systemic and Topical Co-medication Over Time | up to week 52 | Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | 16 weeks | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
| SECONDARY | Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | 52 weeks | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
| SECONDARY | Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set) | week 148 | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
| SECONDARY | Summary of Clinical Global Impression up to End of Trial | up to week 148 (End of Trial) | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
| SECONDARY | Summary of JDA Total Score Category for GPP by Visit up to End of Trial | up to week 148 (End of Trial) | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
| SECONDARY | The Japanese Dermatological Association (JDA) Component Score for GPP Over Time | up to week 148 (end of trial) | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | mean scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP | up to week 148 (end of trial) | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Percent change | MEAN |
| SECONDARY | Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time | Up to week 148 (end of treatment) | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | scores on a scale | MEAN |
| SECONDARY | Number of Patients With GPP-related Systemic and Topical Co-medication Over Time | up to week 52 | Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group254
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Treatment success - Yes | 10 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Treatment success - No | 2 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Very much improved | 9 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Much improved | 1 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Minimally improved | 0 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | No change | 1 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Worse | 0 | Participants | |
| Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Missing | 1 | Participants | |
| Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Treatment success - Yes | 10 | Participants | |
| Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) | AIN457 | Treatment success - No | 2 | Participants |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction | STARTED | AIN457 | 12 | |
| Induction | COMPLETED | AIN457 | 11 | |
| Induction | NOT COMPLETED | AIN457 | 1 | |
| Maintenance | STARTED | AIN457 | 11 | |
| Maintenance | COMPLETED | AIN457 | 9 | |
| Maintenance | NOT COMPLETED | AIN457 | 2 | |
| Treatment Period 3 | STARTED | AIN457 | 9 | |
| Treatment Period 3 | COMPLETED | AIN457 | 0 | |
| Treatment Period 3 | NOT COMPLETED | AIN457 | 9 |
Source ClinicalTrials.gov
Adverse events66
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 | ANAEMIA | Blood and lymphatic system disorders | AIN457 | 1 | 12 | |
| other | ARRHYTHMIA SUPRAVENTRICULAR | Cardiac disorders | AIN457 | 1 | 12 | |
| other | SINUS TACHYCARDIA | Cardiac disorders | AIN457 | 1 | 12 | |
| other | CATARACT | Eye disorders | AIN457 | 1 | 12 | |
| other | CONJUNCTIVAL HAEMORRHAGE | Eye disorders | AIN457 | 1 | 12 | |
| other | CONJUNCTIVITIS ALLERGIC | Eye disorders | AIN457 | 1 | 12 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | AIN457 | 1 | 12 | |
| other | DUODENITIS | Gastrointestinal disorders | AIN457 | 1 | 12 | |
| other | GASTRIC ULCER | Gastrointestinal disorders | AIN457 | 1 | 12 | |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | AIN457 | 1 | 12 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 | ||
| Total, other adverse events | AIN457 | 12 | 12 |
| Total, serious adverse events | AIN457 | 3 | 12 |
Source ClinicalTrials.gov
Papers0
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 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.
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