A Study in Japanese Participants With Moderate-to-Severe Psoriasis
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624233
First received: June 18, 2012
Last updated: June 18, 2013
Last verified: June 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated 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: | June 18, 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 June 18, 2013