A Phase 2 Clinical Study of KHK4827
This study is ongoing, but not recruiting participants.
Sponsor:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01748539
First received: December 10, 2012
Last updated: April 30, 2013
Last verified: April 2013
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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 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (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
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: | April 30, 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 June 18, 2013