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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02533375
Date of registration:	20/08/2015
Prospective Registration:	Yes
Primary sponsor:	AbbVie
Public title:	Study to Investigate Efficacy and Safety of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Scientific title:	A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis
Date of first enrolment:	September 28, 2015
Target sample size:	10
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02533375
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Japan

Contacts

Name:	Anne Robinson, PharmD
Address:
Telephone:
Email:
Affiliation:	AbbVie

Key inclusion & exclusion criteria

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

Age minimum: 15 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Generalized Pustular Psoriasis (GPP)

Adalimumab

Japanese

Intervention(s)

Drug: Adalimumab

Primary Outcome(s)

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

Secondary Outcome(s)

Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time [Time Frame: 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 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Total Erythema Area With Pustules Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time [Time Frame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time [Time Frame: Week 8, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Number of Participants Achieving "Mild" in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With "Moderate" or "Severe" at Baseline Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52]

Mean Change From Baseline in Total Erythema Area Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Number of Participants Achieving Clinical Remission Over Time [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Number of Participants Achieving Clinical Response Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time [Time Frame: Baseline, Week 8, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Serum Albumin Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Body Temperature Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Change From Baseline in Total Edema Area Over Time [Time Frame: Baseline, 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 [Time Frame: 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 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Mean Percent Change From Baseline in Total Skin Score Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52]

Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52]

Secondary ID(s)

M14-193

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	14/01/2019
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02533375

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