A Phase 2 Clinical Study of KHK4827

• ClinicalTrials.gov Identifier: NCT01748539
• Recruitment Status: Completed
• First Posted: December 12, 2012
• Last Update Posted: September 5, 2013
• Sponsor: Kyowa Kirin Co., Ltd.
• Information provided by (Responsible Party): Kyowa Kirin Co., Ltd.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Moderate to Severe Plaque Psoriasis	Drug: KHK4827; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis
• Study Start Date: December 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: KHK4827 70mg SC	Drug: KHK4827
Experimental: KHK4827 140mg SC	Drug: KHK4827
Experimental: KHK4827 210mg SC	Drug: KHK4827
Placebo Comparator: Placebo SC	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. PASI 75 at Week 12 [ Time Frame: 12 Weeks ]
2. PASI 50, 90 and 100 at Week 12 [ Time Frame: 12 weeks ]
3. Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 [ Time Frame: 12 Weeks ]
4. sPGA of "clear (0)" at Week 12 [ Time Frame: 12 weeks ]
5. Body surface area involvement (BSA) of lesion at Week 12 [ Time Frame: 12 weeks ]
6. American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12 [ Time Frame: 12 weeks ]
7. Incidence and types of adverse events and adverse reactions [ Time Frame: 12 weeks ]
8. Profiles of Pharmacokinetics [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Japan

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Chiyoda-ku, Tokyo, Japan

Sponsors and Collaborators

Kyowa Kirin Co., Ltd.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakagawa H, Niiro H, Ootaki K; Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study. J Dermatol Sci. 2016 Jan;81(1):44-52. doi: 10.1016/j.jdermsci.2015.10.009. Epub 2015 Oct 24.

• Responsible Party: Kyowa Kirin Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01748539
• Other Study ID Numbers: 4827-002
• First Posted: December 12, 2012
• Last Update Posted: September 5, 2013
• Last Verified: September 2013

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Brodalumab; Dermatologic Agents