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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01474798
First received: November 15, 2011
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Acne Vulgaris
 Drug: RA-18C3
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    Incidence and type of adverse clinical events


Secondary Outcome Measures:
  • RA-18C3 pharmacokinetics [ Time Frame: 70 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Change in Investigator Global Assessment score from baseline to Day 56


Enrollment: 11
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474798

Locations
United States, California
Moy, Fincher, and Chipps Facial Plastics and Dermatology
Beverly Hills, California, United States, 90210
United States, Florida
Meridien Research
St. Petersburg, Florida, United States, 33709
United States, Texas
Austin Dermatology Associates
Austin, Texas, United States, 78705
Sponsors and Collaborators
XBiotech, Inc.
Investigators
Study Director: Michael D Stecher, MD XBiotech USA, Inc.
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01474798     History of Changes
Other Study ID Numbers: 2011-PT020
Study First Received: November 15, 2011
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by XBiotech, Inc.:
Acne Vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 23, 2013