A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00570986

Enrollment

1465

Registered

2007-12-11

Start date

2007-11-30

Completion date

2009-06-30

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Plaque Psoriasis

Brief summary

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

Interventions

DRUGPlacebo

Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

BIOLOGICALABT-874

200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is \>= 18 years of age * Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis * Subject is judged to be in generally good health as determined by the principal investigator

Exclusion criteria

* Subject has previous exposure to systemic anti-IL 12 therapy * Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy * Subject is taking or requires oral or injectible corticosteroids * Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis * Subject considered by the investigator, for any reason, to be an unsuitable candidate * Female subject who is pregnant or breast-feeding or considering becoming pregnant

Design outcomes

Primary

Measure	Time frame
PGA	Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
PASI	Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12

Secondary

Measure	Time frame
DLQI	Change from Baseline in DLQI total score vs. placebo at Week 12
NAPSI	% change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
PASI	Subjects who achieve PASI 90 and 100 at Week 12
Safety parameters	Throughout study

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026