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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: RA-18C3

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • West Kentucky Dermatology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

11. Infectious disease:

    CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening

12. Immunodeficiency
13. History of treatment with Tysabri or Raptiva
14. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
15. Receipt of a live (attenuated) vaccine within 3 months prior to Screening
16. Major surgery within 28 days prior to Day 0
17. Participation in an investigational drug or device trial within 30 days prior to Screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single group	Drug: RA-18C3; 200 mg subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Incidence and type of adverse clinical events	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RA-18C3 Pharmacokinetics	Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.	56 days
Psoriasis Area and Severity Index (PASI)	Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90	56 days
Erythrocyte Sedimentation Rate		56 days
Physician's Global Assessment Score (PGA)	Change in PGA from baseline to day 56	56 days
Dermatology Life Quality Index Questionnaire (DLQI)	Change in DLQI from baseline to day 56	56 days
C-reactive protein		56 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Principal Investigator: Johann Gudjonsson, M.D., PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2011
• Primary Completion (Actual): July 31, 2012
• Study Completion (Actual): August 31, 2012

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 28, 2011
• First Posted (Estimated): June 29, 2011

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: 2011-PT019