Status:
COMPLETED
Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
This is a 91-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe acne vulgaris. Ten (10) subjects will receive RA-18C3 via subcutaneous inj...
Eligibility Criteria
Inclusion
- Age: ≥ 18
- Moderate to moderately severe inflammatory acne vulgaris:
- Investigator's Global Assessment grade of ≥ 3 and,
- ≥ 15 inflammatory lesions (no more than 6 nodules) and,
- ≥ 15 non-inflammatory lesions
- Four week washout period for topical and oral antibiotic treatment
- Four week washout period for topical retinoids
- Negative pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize 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.
- Subjects weighing ≥ 27 kg
- Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed
Exclusion
- A diagnosis of Acne conglobata, acne fulminans, secondary acne, severe nodulocystic acne requiring treatment with isotretinoin, or other dermatologic conditions requiring interfering phototherapy, topical, or systemic treatment.
- Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- Men with facial hair that would interfere with assessments
- 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.
- Hemoglobin \<10.0 g/dL, or WBC \<3.0 x 103/mm3, or platelet count \<125 x 103/mm3, or creatinine \> 1.5mg/dL, or AST/ALT \>2 x ULN, or alkaline phosphatase \>2 x ULN
- Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
- 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.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
- Infectious disease:
- CRP \>30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
- Immunodeficiency
- Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
- Receipt of a live (attenuated) vaccine within 1 month prior to Screening
- Major surgery within 28 days prior to Day 0
- Participation in an investigational drug or device trial within 30 days prior to Screening
Key Trial Info
Start Date :
February 29 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01474798
Start Date
February 29 2012
End Date
December 31 2012
Last Update
March 30 2025
Active Locations (3)
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1
Moy, Fincher, and Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States, 90210
2
Meridien Research
St. Petersburg, Florida, United States, 33709
3
Austin Dermatology Associates
Austin, Texas, United States, 78705