Clinical trial NCT02533375: Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Official title: A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Pustular Psoriasis (GPP)
Adalimumab
Japanese
Keywords: efficacy
safety
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This was a Phase 3, multicenter, open-label, single-arm study of adalimumab in Japanese participants with generalized pustular psoriasis (GPP). The study included a 30-day screening period, a 52-week treatment period, and a 70-day follow-up period. The dose regimen of adalimumab used in this study was 80 mg at Week 0 by subcutaneous (SC) injection, followed by 40 mg every other week (eow) on and after Week 2 until Week 50. Dose escalation to 80 mg eow was allowed for participants who did not have adequate response on or after Week 8.

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

Primary outcomes:
measure: Proportion of Participants Achieving Clinical Response at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Number of Participants Achieving Clinical Response Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: Number of Participants Achieving Clinical Remission Over Time
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in the Total GPP Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in JDA Severity Index of GPP Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Total Skin Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Percent Change From Baseline in Total Skin Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Total Erythema Area Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Total Erythema Area With Pustules Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Total Edema Area Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Body Temperature Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Serum Albumin Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: 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
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: 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
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time
timeFrame: Week 8, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
timeFrame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52
measure: Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time
timeFrame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52
measure: Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
measure: Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Anne Robinson, PharmD
role: STUDY_DIRECTOR
References: