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

NCT03942042 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 17154I1F-JE-RHCV
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

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.

Conditions

Generalized Pustular Psoriasis; Erythrodermic Psoriasis

Keywords

Generalized Pustular Psoriasis (GPP); Erythrodermic Psoriasis (EP); Japan

Outcome Measures

Primary Outcomes (1)

• 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

  GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.

  Week 12 through Week 20

Secondary Outcomes (12)

• Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved

  Week 20

• Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved

  Week 20

• Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged

  Week 20

• Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened

  Week 20

• Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)

  Week 20

Study Arms (1)

Ixekizumab

EXPERIMENTAL

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.

Drug: Ixekizumab

Interventions

Ixekizumab DRUG

Administered SC

Also known as: LY2439821

Ixekizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173 8606, Japan

Location

Jikei University School of Medicine

Minato-Ku, Tokyo, 105-8471, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Osaka City University Medical School Hospital

Osaka, 545-8586, Japan

Location

Related Publications (1)

• Morita A, Okubo Y, Morisaki Y, Torisu-Itakura H, Umezawa Y. Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis. Dermatol Ther (Heidelb). 2022 Feb;12(2):481-494. doi: 10.1007/s13555-021-00666-x. Epub 2021 Dec 29.

  PMID: 34967916 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 8, 2019
• Study Start: July 5, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: August 13, 2021
• Results First Posted: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

JP (7)