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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03942042
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Generalized Pustular Psoriasis, Erythrodermic Psoriasis
Arms & Interventions

Arms

Experimental: Ixekizumab

Ixekizumab given subcutaneously (SC).

Interventions

Drug: - Ixekizumab

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nagoya City University Hospital, Nagoya, Aichi, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya, Aichi, 467-8602

Tohoku University Hospital, Sendai-shi, Miyagi, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai-shi, Miyagi, 980-8574

Kansai Medical University Hospital, Hirakata, Osaka, Japan

Status

Recruiting

Address

Kansai Medical University Hospital

Hirakata, Osaka, 573-1191

Teikyo University Hospital, Itabashi-ku, Tokyo, Japan

Status

Recruiting

Address

Teikyo University Hospital

Itabashi-ku, Tokyo, 173 8606

Jikei University School of Medicine, Minato-Ku, Tokyo, Japan

Status

Recruiting

Address

Jikei University School of Medicine

Minato-Ku, Tokyo, 105-8471

Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023

Osaka, Japan

Status

Recruiting

Address

Osaka City University Medical School Hospital

Osaka, , 545-8586

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