A Phase 2 Clinical Study of KHK4827

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01748539
First received: December 10, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Moderate to Severe Plaque Psoriasis
Drug: KHK4827
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PASI 75 at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • PASI 50, 90 and 100 at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • sPGA of "clear (0)" at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Body surface area involvement (BSA) of lesion at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • American College of Rheumatology (ACR) 20% response (only in subjects with psoriasis arthritis)at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Profiles of Pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 70mg SC Drug: KHK4827
Experimental: KHK4827 140mg SC Drug: KHK4827
Experimental: KHK4827 210mg SC Drug: KHK4827
Placebo Comparator: Placebo SC Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748539

Locations
Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01748539     History of Changes
Other Study ID Numbers: 4827-002
Study First Received: December 10, 2012
Last Updated: September 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014