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

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: RA-18C3

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Moy, Fincher, and Chipps Facial Plastics and Dermatology
  • Florida
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Incidence and type of adverse clinical events	100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RA-18C3 pharmacokinetics	Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.	70 days
Facial acne lesion count	Change in total facial acne lesion count from day 0 to week 8	56 days
Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts	Percent reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts from day 0 to week 8	56 days
Investigator's Global Assessment (IGA) score	Change in Investigator Global Assessment score from baseline to Day 56	56 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Michael D Stecher, MD, XBiotech USA, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 29, 2012
• Primary Completion (ACTUAL): October 31, 2012
• Study Completion (ACTUAL): December 31, 2012

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (ESTIMATE): November 18, 2011

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Acne Vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 2011-PT020