Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

AbbVie

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: placebo; Drug: Anti IL-12 monoclonal antibody/ABT-874

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292396

M05-736

Details and patient eligibility

About

The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was age 18 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

• Subject had previously received systemic or biologic 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Description:

Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks

Treatment:

Drug: Anti IL-12 monoclonal antibody/ABT-874

2

Active Comparator group

Description:

Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks

Treatment:

Drug: Anti IL-12 monoclonal antibody/ABT-874

3

Active Comparator group

Description:

Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks

Treatment:

Drug: Anti IL-12 monoclonal antibody/ABT-874

4

Active Comparator group

Description:

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks

Treatment:

Drug: Anti IL-12 monoclonal antibody/ABT-874

5

Active Comparator group

Description:

Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks

Treatment:

Drug: Anti IL-12 monoclonal antibody/ABT-874

6

Placebo Comparator group

Description:

placebo, 12 doses

Treatment:

Drug: placebo