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Completed

NCT Number: NCT01748539

A Phase 2 Clinical Study of KHK4827

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Chiyoda-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK4827

Drug

Placebo

Drug

Primary outcomes

  1. Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Parallel Group Study in Subjects With Plaque Psoriasis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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