Overview

This trial is active, not recruiting.

Conditions generalized pustular psoriasis (gpp), adalimumab, japanese
Treatment adalimumab
Phase phase 3
Target TNF-alpha
Sponsor AbbVie
Start date September 2015
End date July 2017
Trial size 10 participants
Trial identifier NCT02533375, M14-193

Summary

The primary objective is to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with generalized pustular psoriasis (GPP).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subcutaneous injection at Week 0 and then every other week on and after Week 2. Dose escalation is allowed for subjects who do not have appropriate response on or after Week 8.
adalimumab
Adalimumab

Primary Outcomes

Measure
Proportion of subjects achieving clinical response
time frame: From Week 0 to Week 16

Secondary Outcomes

Measure
Change in total GPP score
time frame: From Week 2 to Week 52
Change in total skin score
time frame: From Week 2 to Week 52
Change in Body Surface Area of each component of skin score
time frame: From Week 2 to Week 52

Eligibility Criteria

Male or female participants from 15 years up to 75 years old.

Inclusion Criteria: - Diagnosis of generalized pustular psoriasis - Total skin score of at least 3 and erythema with pustule at the Baseline in 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 approved GPP treatment (excluding infliximab) - Infliximab secondary failure, or intolerant to infliximab Exclusion Criteria: - Erythrodermic psoriasis, guttate psoriasis or sub-corneal pustular dermatosis - Drug-induced GPP - Cannot stop ongoing use of prohibited GPP treatments - Total JDA severity index of GPP of 14 or more

Additional Information

Official title A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.