Phase 3
N=10
Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Generalized Pustular Psoriasis (GPP) · Adalimumab · Japanese
Bottom Line
View on ClinicalTrials.gov: NCT02533375 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Jan 2019
Primary outcome: Primary: Proportion of Participants Achieving Clinical Response at Week 16 — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Achieving Clinical Response at Week 16 |
7 | — |
| SECONDARY Number of Participants Achieving Clinical Response Over Time |
5; 6; 6; 5; 6; 6 | — |
| SECONDARY Number of Participants Achieving Clinical Remission Over Time |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in the Total GPP Score Over Time |
-2.9; -3.8; -3.2; -3.1; -4.6; -3.8 | — |
| SECONDARY Mean Change From Baseline in JDA Severity Index of GPP Over Time |
3; 6; 1; 0; 7; 3 | — |
| SECONDARY Mean Change From Baseline in Total Skin Score Over Time |
-1.9; -2.4; -2.3; -2.3; -3.1; -2.6 | — |
| SECONDARY Mean Percent Change From Baseline in Total Skin Score Over Time |
-33.8; -43.4; -42.9; -39.9; -54.6; -46.6 | — |
| SECONDARY Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time |
-1.0; -1.4; -0.9; -0.9; -1.5; -1.1 | — |
| SECONDARY Mean Change From Baseline in Total Erythema Area Over Time |
-17.0; -21.6; -19.7; -23.0; -34.6; -27.6 | — |
| SECONDARY Mean Change From Baseline in Total Erythema Area With Pustules Over Time |
-9.3; -11.7; -8.3; -8.3; -11.8; -7.1 | — |
| SECONDARY Mean Change From Baseline in Total Edema Area Over Time |
-9.1; -12.8; -12.4; -6.3; -15.4; -14.0 | — |
| SECONDARY Mean Change From Baseline in Body Temperature Over Time |
-0.3; -0.5; -0.3; -0.1; -0.3; -0.5 | — |
| SECONDARY Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time |
-1220.0; -1770.0; -810.0; -1650.0; -2562.5; -1162.5 | — |
| SECONDARY Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time |
-1.5; -1.6; -0.3; -1.7; -2.5; -1.5 | — |
| SECONDARY Mean Change From Baseline in Serum Albumin Over Time |
0.0; 0.1; 0.1; -0.2; -0.0; -0.0 | — |
| SECONDARY Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time |
4; 6; 5; 5; 5; 5 | — |
| SECONDARY Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time |
3; 5; 4; 3; 5; 4 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time |
0; 0; 4; 3; 3; 0 | — |
| SECONDARY Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time |
4; 8; 8; 5; 7; 6 | — |
| SECONDARY Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time |
1; 2; 1; 1; 0; 1 | — |
| SECONDARY Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time |
2; 2; 2; 2; 4; 4 | — |
| SECONDARY Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time |
4; 6; 6; 5; 5; 4 | — |
| SECONDARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time |
-12.9; -17.4; -14.9; -14.3; -19.1; -16.8 | — |
| SECONDARY Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time |
-44.2; -59.7; -43.9; -45.0; -55.5; -43.6 | — |
| SECONDARY Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time |
1; 0; 1; 0; 2 | — |
| SECONDARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time |
-4.2; -6.6; -4.8; -6.5; -8.0 | — |
| SECONDARY Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time |
4.7; 9.2; 8.2; 4.9; 12.0; 0.6 | — |
| SECONDARY Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study |
3; 2; 1; 2 | — |
| SECONDARY Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study |
7; 0; 0 | — |
Summary
The purpose of this study was to investigate the efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with generalized pustular psoriasis (GPP) who did not have an adequate response to their currently approved treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of generalized pustular psoriasis
- Total skin score of at least 3 and erythema with pustules (skin score of at least 1) at baseline in the Japan Dermatology Association (JDA) severity index of Generalized Pustular Psoriasis (GPP) in GPP Medical Care Guideline 2014 in Japan
- Inadequate response to, or intolerance to, or contraindication to the currently approved GPP treatment (excluding infliximab)
- Infliximab secondary failure, or intolerant to infliximab
Exclusion Criteria
- Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis at Screening
- Drug-induced GPP
- Cannot stop ongoing use of prohibited GPP treatments
- Total JDA severity index of GPP of 14 or more in GPP Medical Care Guideline 2014 in Japan
Data sourced from ClinicalTrials.gov (NCT02533375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.