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

Lilly

Status and phase: Completed; Phase 4

Conditions: Generalized Pustular Psoriasis; Erythrodermic Psoriasis

Treatments: Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03942042

17154

I1F-JE-RHCV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Ixekizumab

Experimental group

Description:

Induction Dosing Period: Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.

Treatment:

Drug: Ixekizumab