NCT02533375 is a Phase 3 clinical trial of Adalimumab in Generalized Pustular Psoriasis (GPP), sponsored by AbbVie.

Who is sponsoring NCT02533375?

NCT02533375 is sponsored by AbbVie.

What drugs are being tested in NCT02533375?

Interventions in NCT02533375: Adalimumab.

What condition does NCT02533375 study?

NCT02533375 studies Generalized Pustular Psoriasis (GPP), Adalimumab, Japanese.

Is NCT02533375 still recruiting?

NCT02533375 is currently completed. Last updated 14 January 2019.

Are results published for NCT02533375?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-14 · How we verify

NCT02533375

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 14 January 2019

What this trial tests

Phase 3 trial testing Adalimumab in Generalized Pustular Psoriasis (GPP) in 10 participants. Completed in 20 July 2017.

Timeline

28 September 2015

Primary endpoint
15 September 2016

20 July 2017

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	28 September 2015
Primary completion	15 September 2016
Estimated completion	20 July 2017

Drugs / interventions tested

Adalimumab (ADALIMUMAB) — full drug profile →

Conditions studied

Generalized Pustular Psoriasis (GPP) — all drugs for Generalized Pustular Psoriasis (GPP) →
Adalimumab — all drugs for Adalimumab →
Japanese — all drugs for Japanese →

Sponsor

AbbVie — full company profile →

Who can join

Adults 15 to 75, any sex, with Generalized Pustular Psoriasis (GPP) or Adalimumab. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Achieving Clinical Response at Week 16 Primary · 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 wa

Group	Value	95% CI
Participants Receiving Adalimumab	7

Number of Participants Achieving Clinical Response Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	5

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	6

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	6

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	5

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	6

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	6

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	5

Number of Participants Achieving Clinical Remission Over Time Secondary · Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	1

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	0

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	0

Mean Change From Baseline in the Total GPP Score Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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-sensitivit

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-2.9	± 2.08

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-3.8	± 2.15

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-3.2	± 2.57

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-3.1	± 2.85

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-4.6	± 1.85

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-3.8	± 3.15

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-5.5	± 2.07

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-6.0	± 2.55

Mean Change From Baseline in JDA Severity Index of GPP Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Baseline

Group	Value	95% CI
Participants Receiving Adalimumab	3
Participants Receiving Adalimumab	6
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	0

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	7
Participants Receiving Adalimumab	3
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	0

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	9
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	0

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	8
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	0

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	7
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	2

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	7
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	2

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	7
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	1
Participants Receiving Adalimumab	2

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	6
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	0
Participants Receiving Adalimumab	4

Mean Change From Baseline in Total Skin Score Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-1.9	± 1.66

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-2.4	± 1.65

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-2.3	± 1.49

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-2.3	± 1.98

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-3.1	± 1.36

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-2.6	± 1.92

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-3.8	± 1.47

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-4.2	± 1.79

Mean Percent Change From Baseline in Total Skin Score Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-33.8	± 27.71

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-43.4	± 27.28

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-42.9	± 27.12

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-39.9	± 30.36

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-54.6	± 20.77

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-46.6	± 33.15

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-67.9	± 13.58

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-72.3	± 16.34

Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-1.0	± 1.05

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-1.4	± 0.97

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-0.9	± 1.45

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-0.9	± 1.25

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-1.5	± 1.20

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-1.1	± 1.64

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-1.7	± 1.21

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-1.8	± 1.30

Mean Change From Baseline in Total Erythema Area Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-17.0	± 20.08

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-21.6	± 22.81

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-19.7	± 26.62

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-23.0	± 26.28

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-34.6	± 27.30

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-27.6	± 29.48

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-48.3	± 27.72

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-44.6	± 37.50

Mean Change From Baseline in Total Erythema Area With Pustules Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-9.3	± 8.96

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-11.7	± 9.01

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-8.3	± 11.42

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-8.3	± 14.63

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-11.8	± 10.65

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-7.1	± 16.75

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-13.3	± 12.44

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-14.8	± 13.31

Mean Change From Baseline in Total Edema Area Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

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.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-9.1	± 9.45

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-12.8	± 11.29

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-12.4	± 17.30

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-6.3	± 31.96

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-15.4	± 17.30

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-14.0	± 17.72

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-21.2	± 14.68

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-18.6	± 14.31

Mean Change From Baseline in Body Temperature Over Time Secondary · Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52

Body temperature (oral) was obtained at each visit prior to blood sampling.

Week 2

Group	Value	95% CI
Participants Receiving Adalimumab	-0.3	± 0.68

Week 4

Group	Value	95% CI
Participants Receiving Adalimumab	-0.5	± 0.52

Week 8

Group	Value	95% CI
Participants Receiving Adalimumab	-0.3	± 0.50

Week 12

Group	Value	95% CI
Participants Receiving Adalimumab	-0.1	± 0.64

Week 16

Group	Value	95% CI
Participants Receiving Adalimumab	-0.3	± 0.50

Week 24

Group	Value	95% CI
Participants Receiving Adalimumab	-0.5	± 1.04

Week 36

Group	Value	95% CI
Participants Receiving Adalimumab	-0.3	± 0.86

Week 52

Group	Value	95% CI
Participants Receiving Adalimumab	-0.1	± 0.64

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants Receiving Adalimumab

Serious: 3/10 (30%)

Deaths: 0/10

Serious adverse events (6 terms)

Reaction	System	Participants Receiving Ada…
Cardiac failure	Cardiac disorders	—
Chronic sinusitis	Infections and infestations	—
Enterocolitis bacterial	Infections and infestations	—
Dehydration	Metabolism and nutrition disorders	—
Renal failure	Renal and urinary disorders	—
Pustular psoriasis	Skin and subcutaneous tissue disorders	—

Other adverse events (43 terms — click to expand)

Reaction	System	Participants Receiving Ada…
Nasopharyngitis	Infections and infestations	—
Pruritus	Skin and subcutaneous tissue disorders	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Eosinophilia	Blood and lymphatic system disorders	—
Cardiac failure	Cardiac disorders	—
Autoimmune Thyroiditis	Endocrine disorders	—
Dry eye	Eye disorders	—
Episcleritis	Eye disorders	—
Glaucoma	Eye disorders	—
Abdominal pain	Gastrointestinal disorders	—
Oedema	General disorders	—
Oedema peripheral	General disorders	—
Pyrexia	General disorders	—
Hepatic Function Abnormal	Hepatobiliary disorders	—
Hepatic Steatosis	Hepatobiliary disorders	—
Liver disorder	Hepatobiliary disorders	—
Bacterial infection	Infections and infestations	—
Body tinea	Infections and infestations	—
Cellulitis	Infections and infestations	—
Chronic sinusitis	Infections and infestations	—
Enterocolitis bacterial	Infections and infestations	—
Enterocolitis infectious	Infections and infestations	—
Folliculitis	Infections and infestations	—
Herpes zoster	Infections and infestations	—
Infection	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Contusion	Injury, poisoning and procedural complications	—
Eye contusion	Injury, poisoning and procedural complications	—
Patella fracture	Injury, poisoning and procedural complications	—
Tooth fracture	Injury, poisoning and procedural complications	—
Dehydration	Metabolism and nutrition disorders	—
Hyperlipidaemia	Metabolism and nutrition disorders	—
Hypoglycaemia	Metabolism and nutrition disorders	—
Hypokalaemia	Metabolism and nutrition disorders	—
Malnutrition	Metabolism and nutrition disorders	—
Periarthritis	Musculoskeletal and connective tissue disorders	—
Spondylolisthesis	Musculoskeletal and connective tissue disorders	—
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Insomnia	Psychiatric disorders	—
Renal failure	Renal and urinary disorders	—

Most-reported serious reactions: Cardiac failure, Chronic sinusitis, Enterocolitis bacterial, Dehydration, Renal failure, Pustular psoriasis.

Data from ClinicalTrials.gov NCT02533375 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Adalimumab treatment in Japanese patients with generalized pustular psoriasis: Results of an open-label phase 3 study.
Morita A, Yamazaki F, Matsuyama T, Takahashi K, et al · · 2018 · cited 49× · PMID 30302793 · DOI 10.1111/1346-8138.14664
Pustular Psoriasis: From Pathophysiology to Treatment.
Genovese G, Moltrasio C, Cassano N, Maronese CA, et al · · 2021 · cited 40× · PMID 34944562 · DOI 10.3390/biomedicines9121746
Current Treatments for Generalized Pustular Psoriasis: A Narrative Summary of a Systematic Literature Search.
Puig L, Fujita H, Thaçi D, Zheng M, et al · · 2024 · cited 8× · PMID 39088126 · DOI 10.1007/s13555-024-01230-z
Considerations for Treating Generalized Pustular Psoriasis (GPP): A Narrative Review.
Lynde CW, Prajapati VH, Gooderham MJ, Hong HC, et al · · 2025 · PMID 41066059 · DOI 10.1007/s13555-025-01535-7

Verify or expand the search:

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Trials testing the same drug.

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Other recruiting trials for Generalized Pustular Psoriasis (GPP)

Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02533375 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 14 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02533375.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02533375

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Adalimumab

Other recruiting trials for Generalized Pustular Psoriasis (GPP)

Other AbbVie trials

Verify against primary sources