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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Generalized Pustular Psoriasis (GPP); Japanese; Adalimumab

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02533375

M14-193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Participants receiving adalimumab

Experimental group

Description:

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.

Treatment:

Drug: Adalimumab