Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RA-18C3
|
Drug: RA-18C3
For subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection.
For subjects weighing > 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection.
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability [100 days]
Incidence and type of adverse clinical events
Secondary Outcome Measures
- RA-18C3 pharmacokinetics [70 days]
Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.
- Facial acne lesion count [56 days]
Change in total facial acne lesion count from day 0 to week 8
- Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts [56 days]
Percent reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts from day 0 to week 8
- Investigator's Global Assessment (IGA) score [56 days]
Change in Investigator Global Assessment score from baseline to Day 56
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age: ≥ 18
-
Moderate to moderately severe inflammatory acne vulgaris:
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Investigator's Global Assessment grade of ≥ 3 and,
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≥ 15 inflammatory lesions (no more than 6 nodules) and,
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≥ 15 non-inflammatory lesions
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Four week washout period for topical and oral antibiotic treatment
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Four week washout period for topical retinoids
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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.
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Subjects weighing ≥ 27 kg
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Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed
Exclusion Criteria:
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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.
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Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
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Men with facial hair that would interfere with assessments
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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.
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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
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Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
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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.
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History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
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History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
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Infectious disease:
- CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
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Immunodeficiency
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Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
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Receipt of a live (attenuated) vaccine within 1 month prior to Screening
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Major surgery within 28 days prior to Day 0
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Participation in an investigational drug or device trial within 30 days prior to Screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moy, Fincher, and Chipps Facial Plastics and Dermatology | Beverly Hills | California | United States | 90210 |
| 2 | Meridien Research | Saint Petersburg | Florida | United States | 33709 |
| 3 | Austin Dermatology Associates | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Michael D Stecher, MD, XBiotech USA, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011-PT020