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

NCT02533375 | Completed Phase 3 Results

• 1 other identifier: M14-193
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Generalized Pustular Psoriasis (GPP); Adalimumab; Japanese

Keywords

efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Clinical Response at Week 16

  Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.

  Baseline and Week 16

Secondary Outcomes (28)

• Number of Participants Achieving Clinical Response Over Time

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

• Number of Participants Achieving Clinical Remission Over Time

  Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

• Mean Change From Baseline in the Total GPP Score Over Time

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

• Mean Change From Baseline in JDA Severity Index of GPP Over Time

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

• Mean Change From Baseline in Total Skin Score Over Time

  Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Study Arms (1)

Participants receiving adalimumab

EXPERIMENTAL

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.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab pre-filled syringe, administered by subcutaneous injection

Also known as: Humira, ABT-D2E7

Participants receiving adalimumab

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• AbbVie

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Anne Robinson, PharmD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 26, 2015
• Study Start: September 28, 2015
• Primary Completion: September 15, 2016
• Study Completion: July 20, 2017
• Last Updated: January 14, 2019
• Results First Posted: January 14, 2019

Record last verified: 2018-07