Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris

Completed · Phase 2

Conditions studied: Acne Vulgaris

In brief

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 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 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.

Key facts

Study ID

NCT01474798

Run by

Janssen Research & Development, LLC

People needed

11

Starts

2012-02-29

Expected to finish

2012-12-31

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moy, Fincher, and Chipps Facial Plastics and Dermatology — Beverly Hills, California, United States
• Meridien Research — St. Petersburg, Florida, United States
• Austin Dermatology Associates — Austin, Texas, United States

Full record on ClinicalTrials.gov

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