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Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis

A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-inflammatory Therapeutic Antibody (RA-18C3) in Subjects With Moderate to Severe Plaque Psoriasis

NCT01384630•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects 18 years of age or older
•2. Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions.
•3. Psoriasis area-and-severity index (PASI) score of ≥ 12
•4. Involvement of ≥ 5% of body-surface area
•5. For female subjects of childbearing age, a negative urine pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize adequate, double barrier contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion.
•6. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed

Exclusion Criteria

•1. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
•2. Treatment with conventional systemic psoriasis therapy within last 4 weeks
•3. Treatment with phototherapy within the last 4 weeks
•4. Topical psoriasis treatment with the last 2 weeks
•5. History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
•6. Hemoglobin \<10.0 g/dL, WBC \<3.0 x 103/mm3, platelet count \<125 x 103/mm3, creatinine \> 1.5mg/dL, AST/ALT \>2 x ULN, alkaline phosphatase \>2 x ULN
•7. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
•8. History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
•9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
•10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
+8 more criteria

Locations (3)

West Kentucky Dermatology

Owensboro, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Westlake Dermatology

Austin, Texas, United States

Key Dates

Start Date

September 30, 2011

Primary Completion Date

July 31, 2012

Completion Date

August 31, 2012

Last Updated

March 30, 2025

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

RA-18C3

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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RECRUITINGPHASE3

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RECRUITINGPHASE3

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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: March 30, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe 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