CompletedNCT00338754Updated Sep 11, 2007

Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase 2/3 interventional study of Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks in Psoriasis, sponsored by Abbott. Completed at 8 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2007-09-11.

Sponsored by Abbott · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 160
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.

Conditions studied

Psoriasis

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Psoriasis 1,899

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 160 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

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Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history.
Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion criteria

Exclusion Criteria:

Subject had previously received anti-TNF therapy.
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy
Subject is taking or requires oral or injectable corticosteroids
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 160 participants

Interventions

DrugHuman anti-TNF monoclonal antibody adalimumab/ up to 24 weeks

What researchers measure

Primary outcomes

Proportion of subjects with clinical response relative to Baseline PASI score

Secondary outcomes

QoLs
Clinical response indicators
Safety parameters

Study locations

8 sites

Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kanto, Japan
Kinki, Japan
Kyusyu, Japan
Shikoku, Japan
Tohoku, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00338754
Lead sponsor: Abbott
Collaborators: Eisai Limited
First posted: Jun 20, 2006
Start date: Nov 2005
Last update: Sep 11, 2007

Study contacts

Noritaka Inomata, Ph.D.

study director · Abbott Japan Co.,Ltd

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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