Clinical trial NCT01384630: Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 56 days
Secondary outcomes:
measure: RA-18C3 Pharmacokinetics
timeFrame: 56 days
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: 56 days
measure: Erythrocyte Sedimentation Rate
timeFrame: 56 days
measure: Physician's Global Assessment Score (PGA)
timeFrame: 56 days
measure: Dermatology Life Quality Index Questionnaire (DLQI)
timeFrame: 56 days
measure: C-reactive protein
timeFrame: 56 days
Other outcomes:
Locations:
city: Owensboro
country: United States
facility: West Kentucky Dermatology
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Austin
country: United States
facility: Westlake Dermatology
state: Texas
Study officials:
affiliation: University of Michigan
name: Johann Gudjonsson, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: