A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis

Incyte

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Itacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634087

INCB 39110-250

Details and patient eligibility

About

This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol

Exclusion criteria

• Females who are pregnant or breastfeeding
• Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
• Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 8 patient groups

100 mg QD Itacitinib

Experimental group

Treatment:

Drug: Itacitinib

100 mg QD Placebo

Experimental group

Treatment:

Drug: Placebo

200 mg QD Itacitinib

Experimental group

Treatment:

Drug: Itacitinib

200 mg QD Placebo

Experimental group

Treatment:

Drug: Placebo

200 mg BID Itacitinib

Experimental group

Treatment:

Drug: Itacitinib

200 mg BID Placebo

Experimental group

Treatment:

Drug: Placebo

600 mg once a day Itacitinib

Experimental group

Treatment:

Drug: Itacitinib

600 mg once a day Placebo

Experimental group

Treatment:

Drug: Placebo