A Study in Japanese Participants With Moderate-to-Severe Psoriasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624233
First received: June 18, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.


Condition Intervention Phase
Psoriasis
Drug: 80 mg ixekizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: static Physician Global Assessment (sPGA) [ Time Frame: Baseline up to 292 weeks ] [ Designated as safety issue: No ]
  • Efficacy of ixekizumab in participants with moderate to severe plaque psoriasis. Measure: Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline up to 292 weeks ] [ Designated as safety issue: No ]
  • Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline up to 292 weeks ] [ Designated as safety issue: No ]
  • Efficacy of ixekizumab in participants with psoriatic arthritis. Measure: Pain Visual Analog Scale (VAS) [ Time Frame: Baseline up to 292 weeks ] [ Designated as safety issue: No ]
  • Efficacy of ixekizumab in participants with psoriatic arthritis. Measure: American College of Rheumatology 20 (ACR20) [ Time Frame: Baseline up to 292 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 80 mg ixekizumab
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 until Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.
Drug: 80 mg ixekizumab
Administered SC
Other Name: LY2439821

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men must agree to use a reliable method of birth control during the study
  • Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
  • Candidates for phototherapy and/or systemic therapy
  • Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
  • At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
  • Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis

Exclusion Criteria:

  • History of drug-induced psoriasis
  • Concurrent or recent use of any biologic agent
  • Received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy) or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
  • Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
  • Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
  • Serious disorder or illness other than psoriasis
  • Serious infection within the last 3 months
  • Breastfeeding or nursing (lactating) women
  • Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624233

Locations
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, Japan, 791-0295
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, Japan, 830-0011
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gifu, Japan, 501-1194
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, Japan, 060-0814
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyogo, Japan, 514-8507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ishikawa, Japan, 920-8641
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Iwate, Japan, 020-8505
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kanagawa, Japan, 259-1193
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kumamoto, Japan, 860-0811
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kyoto, Japan, 606-8397
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miyazaki, Japan, 889-1692
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagano, Japan, 390-8621
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Okayama, Japan, 700-8558
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka, Japan, 565-0871
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Osaka-Pref, Japan, 589
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saitama, Japan, 350-0495
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan, 162-8666
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01624233     History of Changes
Other Study ID Numbers: 13976, I1F-JE-RHAT
Study First Received: June 18, 2012
Last Updated: October 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 16, 2014