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

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ClinicalTrials.gov Identifier: NCT01474798
Recruitment Status : Completed
First Posted : November 18, 2011
Last Update Posted : February 17, 2021
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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
Acne Vulgaris Drug: RA-18C3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Acne Vulgaris
Actual Study Start Date : February 29, 2012
Actual Primary Completion Date : October 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 100 days ]
    Incidence and type of adverse clinical events

Secondary Outcome Measures :
  1. RA-18C3 pharmacokinetics [ Time Frame: 70 days ]
    Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.

  2. Facial acne lesion count [ Time Frame: 56 days ]
    Change in total facial acne lesion count from day 0 to week 8

  3. Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts [ Time Frame: 56 days ]
    Percent reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts from day 0 to week 8

  4. Investigator's Global Assessment (IGA) score [ Time Frame: 56 days ]
    Change in Investigator Global Assessment score from baseline to Day 56

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age: ≥ 18
  2. 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
  3. Four week washout period for topical and oral antibiotic treatment
  4. Four week washout period for topical retinoids
  5. 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.
  6. Subjects weighing ≥ 27 kg
  7. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed

Exclusion Criteria:

  1. 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.
  2. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
  3. Men with facial hair that would interfere with assessments
  4. 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.
  5. 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
  6. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
  7. 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.
  8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  9. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
  10. Infectious disease:

    • CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
  11. Immunodeficiency
  12. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
  13. Receipt of a live (attenuated) vaccine within 1 month prior to Screening
  14. Major surgery within 28 days prior to Day 0
  15. Participation in an investigational drug or device trial within 30 days prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474798

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United States, California
Moy, Fincher, and Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States, 90210
United States, Florida
Meridien Research
Saint Petersburg, Florida, United States, 33709
United States, Texas
Austin Dermatology Associates
Austin, Texas, United States, 78705
Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Michael D Stecher, MD XBiotech USA, Inc.
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01474798    
Other Study ID Numbers: 2011-PT020
First Posted: November 18, 2011    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Keywords provided by Janssen Research & Development, LLC:
Acne Vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases