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

Conditions

• Adalimumab
• Generalized Pustular Psoriasis (GPP)
• Japanese

Eligibility Criteria

Sex

ALL

Age

15 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — DRUG
  Adalimumab pre-filled syringe, administered by subcutaneous injection

Study Details

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.

Key Dates

Start date

Sep 28, 2015

Status verified

Jul 2018

Primary completion

Sep 15, 2016

Completion

Jul 20, 2017

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Proportion of Participants Achieving Clinical Response at Week 16 [ Time Frame: Baseline and Week 16 ]