Generalized Pustular Psoriasis (GPP)Phase 3NCT02533375

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

A Phase 3 study testing Adalimumab in people with Generalized Pustular Psoriasis (GPP) and Adalimumab, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 15 to 75 years
Conditions the study is for: Generalized Pustular Psoriasis (GPP), Adalimumab, Japanese
What is being tested?: Adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 28 Sep 2015to 20 Jul 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis

Read the detailed 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.

Conditions: Generalized Pustular Psoriasis (GPP), Adalimumab, Japanese
Being tested: Adalimumab
Keywords: efficacy, safety
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdalimumabDrug
Also called Humira, ABT-D2E7
Adalimumab pre-filled syringe, administered by subcutaneous injection

Study groups in NCT02533375
Study group	Role	What they receive
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. Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 16

Secondary outcomes (28)

Number of Participants Achieving Clinical Response Over Time
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.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Number of Participants Achieving Clinical Remission Over Time
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated 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 remission was defined as a total skin score of 0.
Measured: 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
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.
Measured: 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
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17.
Measured: 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
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated 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). Negative values indicate improvement from baseline.
Measured: 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
The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated 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). Negative values indicate improvement from baseline.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time
The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.
Measured: 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 Over Time
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and < 75%; mild, < 25%); and none (0%). Negative values indicate improvement from baseline.
Measured: 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
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.
Measured: 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
The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.
Measured: 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
Body temperature (oral) was obtained at each visit prior to blood sampling.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time
Blood was drawn at each study visit, and white blood cell concentration was determined.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time
Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined.
Measured: 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
Blood was drawn at each study visit, and serum albumin concentration was determined.
Measured: 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
The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as "Mild", "Moderate" is 7-10, and "Severe" is 11-17.
Measured: 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
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.
Measured: 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
The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.
Measured: 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
The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: 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 75 (PASI 75) Over Time
The proportion of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: 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
The proportion of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time
The mean change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.
Measured: 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
The percent change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.
Measured: 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
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Measured: Week 8, Week 16, Week 24, Week 36, Week 52
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline.
Measured: Baseline, Week 8, 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
The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.
Measured: Baseline, Week 8, 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
GPP-specific co-medications were documented at each scheduled study visit.
Measured: 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 Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study
Participants using topical co-medications for GPP were documented at each scheduled study visit.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 201520 Jul 2017

First posted26 Aug 2015 (estimated)
Study start28 Sep 2015
Primary completion15 Sep 2016
Study completion20 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Generalized Pustular Psoriasis (GPP)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02533375
Sponsor's protocol ID: M14-193
Status last verified: Jul 2018
First submitted: 20 Aug 2015
Last updated: 14 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
A Trial Evaluating the Efficacy and Safety of SHR-1139 Injection in Adult Patients With Palmoplantar Pustulosis
Palmoplantar Pustulosis of Adults
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 2
A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis
Palmoplantar Pustulosis
Active, not recruitingObservational study
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis
Psoriasis
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Generalized Pustular Psoriasis, Erythrodermic Psoriasis

All Generalized Pustular Psoriasis (GPP) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Study of Adalimumab in Japanese Subjects With Generalized Pustular Psoriasis
ClinicalTrials.gov ID: NCT02533375
Acronym / sponsor ID: M14-193
Conditions: Generalized Pustular Psoriasis (GPP), Adalimumab, Japanese
Keywords: efficacy, safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 28 Sep 2015
Primary completion: 15 Sep 2016 (actual)
Study completion: 20 Jul 2017 (actual)
First posted: 26 Aug 2015 (estimated)
Results: Posted 14 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Participants receiving adalimumab	Experimental	Drug: Adalimumab80 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.

Who may qualify

Ages: 15 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdalimumabAlso: Humira, ABT-D2E7Adalimumab pre-filled syringe, administered by subcutaneous injection	Drug	Participants receiving adalimumab

Primary outcome

Proportion of Participants Achieving Clinical Response at Week 16
Time frame: Baseline and 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.

28 secondary outcomes

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
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
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 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 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
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 Total Erythema 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 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 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 Body Temperature 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 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
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
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
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
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
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
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 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 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 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 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 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 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 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 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
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 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

Results and safety

Results posted to the registry on 14 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Receiving Adalimumab	10	5

Primary outcome: Proportion of Participants Achieving Clinical Response at Week 16

Time frame: Baseline and Week 16. Count of participants. Unit: Participants

Measure	Participants Receiving Adalimumab n = 10
Value	7

Population analysed: Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data

28 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 62 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Receiving Adalimumab	3 of 10 (30%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AbbVieLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne Robinson, PharmD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Generalized Pustular Psoriasis (GPP) and Adalimumab, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving Clinical Response at Week 16 (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.