Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-28

Study Completion Date

2017-07-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Generalized Pustular Psoriasis (GPP) Adalimumab Japanese

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants receiving adalimumab

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.

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

Adalimumab pre-filled syringe, administered by subcutaneous injection

Interventions

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Adalimumab

Adalimumab pre-filled syringe, administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Humira ABT-D2E7

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No