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A Study for Adults With Plaque Psoriasis | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study for Adults With Plaque Psoriasis

LY2525623 (IL-23 Antibody) Multiple-Dose Study in Adults With Plaque Psoriasis

NCT01018810•Eli Lilly and Company

Summary

In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate(\<1% per year) during the study.
•Chronic psoriasis vulgaris for at least 6 months prior to randomization.
•Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA) or at least 8% BSA in subjects with severe palmar-plantar involvement at randomization.
•Psoriasis Area and Severity Index (PASI) total score of at least 12 at screening.

Exclusion Criteria

•Have had a clinically significant flare of psoriasis during the 12 weeks prior to randomization or a biologic agent/monoclonal antibody within the longer of 5 half lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within 2 weeks prior to dosing.
•Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to have one within 4 weeks after the dosing period.
•Are immunocompromised or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus \[HIV\]); or have had a recent serious systemic infection (such as mononucleosis or herpes zoster).
•Have a history of or current lymphoproliferative disease or malignant disease (except for resolved cervical dysplasia; or no more than 3 successfully treated basal- or squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity.
•Have a history of serious cardiac disease within 12 weeks before randomization; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.
•Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant and/or have any of the following specific abnormalities:
•* Aspartate transaminase (AST) or alanine transaminase (ALT) \>2 x the upper limit of normal (ULN; upper reference range of the central laboratory for the study)
•* Hemoglobin \<100 g/L (10 g/dL)
•* White blood cell (WBC) \<3.0 G/L (3,000/mm3)
•* Neutrophils \<1.5 G/L (1,500/mm3)
+4 more criteria

Locations (28)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mobile, Alabama, United States

Peoria, Arizona, United States

Hot Springs, Arkansas, United States

Fremont, California, United States

Los Angeles, California, United States

San Diego, California, United States

Santa Monica, California, United States

Jacksonville, Florida, United States

Ocala, Florida, United States

South Miami, Florida, United States

Key Dates

Start Date

December 1, 2009

Primary Completion Date

May 1, 2010

Completion Date

August 1, 2010

Last Updated

July 29, 2011

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

LY2525623 Intravenous

DRUG

LY2525623 Subcutaneous

DRUG

Placebo Intravenous

DRUG

Placebo Subcutaneous

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

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Psoriasis

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Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study for Adults With Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments