Phase 4
N=12
A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Generalized Pustular Psoriasis · Erythrodermic Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT03942042 ↗Enrolled (actual)
12
Serious AEs
5.6%
Results posted
Aug 2021
Primary outcome: Primary: Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS — 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ixekizumab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS |
1; 0 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved |
1; 0 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved |
1; 4 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged |
0; 0 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened |
0; 0 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1) |
2; 1 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) |
2; 3 | — |
| SECONDARY Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline |
-9.0; -25.5 | — |
| SECONDARY Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis |
-44.5; -61.3 | — |
| SECONDARY Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score |
-4.0; -6.5 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) |
0; 0 | — |
| SECONDARY Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) |
0; 0 | — |
| SECONDARY Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index |
-2.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03942042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.