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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03942042
• Date of registration: 07/05/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
• Scientific 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
• Date of first enrolment: July 5, 2019
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03942042
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Japan

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Erythrodermic Psoriasis

Generalized Pustular Psoriasis

Intervention(s)

Drug: Ixekizumab

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of Participants with GIS grade 1: Resolved [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) [Time Frame: Week 20]

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

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

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

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

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

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

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

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

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

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

Secondary ID(s)

I1F-JE-RHCV

17154

Source(s) of Monetary Support

Please refer to primary and secondary sponsors