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A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942042
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.

Condition or disease Intervention/treatment Phase
Generalized Pustular Psoriasis Erythrodermic Psoriasis Drug: Ixekizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: Ixekizumab
Ixekizumab given subcutaneously (SC).
Drug: Ixekizumab
Administered SC
Other Name: LY2439821




Primary Outcome Measures :
  1. Number of Participants who Improved Global Improvement Score (GIS) at Least 1 Point from Week 12 and with ≤2 of GIS [ Time Frame: Week 12 through Week 20 ]
    Number of Participants who Improved Global Improvement Score (GIS) at Least 1 Point from Week 12 and with ≤2 of GIS


Secondary Outcome Measures :
  1. Number of Participants with GIS grade 1: Resolved [ Time Frame: Week 20 ]
    Number of Participants with GIS grade 1: Resolved

  2. Number of Participants with GIS grade 2: Improved [ Time Frame: Week 20 ]
    Number of Participants with GIS grade 2: Improved

  3. Number of Participants with GIS grade 3: Unchanged [ Time Frame: Week 20 ]
    Number of Participants with GIS grade 3: Unchanged

  4. Number of Participants with GIS grade 4: Worsened [ Time Frame: Week 20 ]
    Number of Participants with GIS grade 4: Worsened

  5. Number of Participants who Achieved static Physician Global Assessment (sPGA) (0, 1) [ Time Frame: Week 20 ]
    Number of Participants who Achieved sPGA (0, 1)

  6. Number of Participants who Achieved at Least a 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) [ Time Frame: Week 20 ]
    Number of Participants who Achieved at Least a 75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75)

  7. Change from Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants with Scalp Involvement at Baseline [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in PSSI in Participants with Scalp Involvement at Baseline

  8. Change from Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in Percent of BSA Involvement of Psoriasis

  9. Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline, Week 20 ]
    Change from Baseline in DLQI Total Score

  10. Number of Participants who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) [ Time Frame: Week 20 ]
    Number of Participants who Developed TE-ADA

  11. Number of Participants who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) [ Time Frame: Week 20 ]
    Number of Participants who Developed NAb

  12. Generalized Pustular Psoriasis (GPP) Only: Change from Baseline on Generalized Pustular Psoriasis Severity Index [ Time Frame: Baseline, Week 20 ]
    Change from Baseline on Generalized Pustular Psoriasis Severity Index



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria

    • GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.
    • EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.
  • Candidates for phototherapy and/or systemic therapy
  • 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

Exclusion Criteria:

  • History of drug-induced psoriasis
  • Concurrent or recent use of any biologic agent
  • Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
  • Have previously received ixekizumab
  • Serious disorder or illness other than psoriasis
  • Serious infection within the last 12 weeks
  • Breastfeeding or nursing (lactating) women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942042


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
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Japan
Nagoya City University Hospital Recruiting
Nagoya, Aichi, Japan, 467-8602
Contact    81120360605      
Principal Investigator: Akimichi Morita         
Tohoku University Hospital Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Contact    81120360605      
Principal Investigator: Kenshi Yamasaki         
Kansai Medical University Hospital Recruiting
Hirakata, Osaka, Japan, 573-1191
Contact    81120360605      
Principal Investigator: Hiroyuki Okamoto         
Teikyo University Hospital Recruiting
Itabashi-ku, Tokyo, Japan, 173 8606
Contact    81120360605      
Principal Investigator: Yayoi Tada         
Jikei University School of Medicine Recruiting
Minato-Ku, Tokyo, Japan, 105-8471
Contact    81120360605      
Principal Investigator: Yoshinori Umezawa         
Tokyo Medical University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Contact    81120360605      
Principal Investigator: Yukari Okubo         
Osaka City University Medical School Hospital Recruiting
Osaka, Japan, 545-8586
Contact    81120360605      
Principal Investigator: Chiharu Tateishi         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03942042    
Other Study ID Numbers: 17154
I1F-JE-RHCV ( Other Identifier: Eli Lilly and Company )
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eli Lilly and Company:
Generalized Pustular Psoriasis (GPP)
Erythrodermic Psoriasis (EP)
Japan
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Dermatologic Agents