A Phase 2 Clinical Study of KHK4827

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: Placebo; Drug: KHK4827

Study type: Interventional

Funder types: Industry

Identifiers

NCT01748539

4827-002

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis in a randomized, double-blind, placebo-controlled, parallel group study. Pharmacokinetics of KHK4827 will also be assessed.

Enrollment: 140 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
• Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
• Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion criteria

• Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.

• Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.

• Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection

• Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.

• Subject has used the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus

  , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)

• Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy

• Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines

• Subject has used ustekinumab within 6 months of the first dose

• Subject has previously used an anti-interleukin-17 biologic therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups, including a placebo group

KHK4827 70mg SC

Experimental group

Treatment:

Drug: KHK4827

KHK4827 140mg SC

Experimental group

Treatment:

Drug: KHK4827

KHK4827 210mg SC

Experimental group

Treatment:

Drug: KHK4827

Placebo SC

Placebo Comparator group

Treatment:

Drug: Placebo