Trial · NCT02533375
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
NCT02533375, Phase 3, Completed, AbbVie; results first posted 2019-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP). Trials, record NCT02533375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02533375
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
- NCT number
- NCT02533375
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Generalized Pustular Psoriasis (GPP), Adalimumab, Japanese
- Interventions
- Adalimumab
- First posted
- 2015-08-26
- Last updated
- 2019-01-14
- Results first posted
- 2019-01-14
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Achieving Clinical Response at Week 16 | Baseline and Week 16 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
| Secondary | Number of Participants Achieving Clinical Response Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0. |
| Secondary | Number of Participants Achieving Clinical Remission Over Time | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0. |
| Secondary | Mean Change From Baseline in the Total GPP Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17. |
| Secondary | Mean Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Secondary | Mean Percent Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score (\[range 0-8, with 8 representing severe disease\] assesses body temperature, white blood cell \[WBC\] count, high-sensitivity C-reactive protein \[hs-CRP\], and serum albumin). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Erythema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and \< 75%; mild, \< 25%); and none (0%). Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and \< 50%; mild, \< 10%); and none (0%). Negative values indicate improvement from baseline. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Achieving Clinical Response at Week 16 | Baseline and Week 16 | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Clinical Response Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Clinical Remission Over Time | Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the Total GPP Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in JDA Severity Index of GPP Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | units on a scale | MEAN |
| SECONDARY | Mean Percent Change From Baseline in Total Skin Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | percentage change from baseline | MEAN |
| SECONDARY | Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Erythema Area Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Erythema Area With Pustules Over Time | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52 | Participants with available data | units on a scale | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group285
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Achieving Clinical Response at Week 16 | Participants Receiving Adalimumab | 7 | Participants | ||
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 2 | 5 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 4 | 6 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 8 | 6 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 12 | 5 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 24 | 6 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 36 | 6 | participants | |
| Number of Participants Achieving Clinical Response Over Time | Participants Receiving Adalimumab | Week 52 | 5 | participants | |
| Number of Participants Achieving Clinical Remission Over Time | Participants Receiving Adalimumab | Week 2 | 0 | participants | |
| Number of Participants Achieving Clinical Remission Over Time | Participants Receiving Adalimumab | Week 4 | 1 | participants |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Receiving Adalimumab | 10 | |
| Overall Study | COMPLETED | Participants Receiving Adalimumab | 5 | |
| Overall Study | NOT COMPLETED | Participants Receiving Adalimumab | 5 |
Source ClinicalTrials.gov
Adverse events49
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 | Eosinophilia | Blood and lymphatic system disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Cardiac failure | Cardiac disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Autoimmune Thyroiditis | Endocrine disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Dry eye | Eye disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Episcleritis | Eye disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Glaucoma | Eye disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Oedema | General disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Oedema peripheral | General disorders | Participants Receiving Adalimumab | 1 | 10 | |
| other | Pyrexia | General disorders | Participants Receiving Adalimumab | 1 | 10 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Receiving Adalimumab | 0 | 10 |
| Total, other adverse events | Participants Receiving Adalimumab | 9 | 10 |
| Total, serious adverse events | Participants Receiving Adalimumab | 3 | 10 |
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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