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

NCT01474798 | Completed Phase 2

• 1 other identifier: 2011-PT020
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence and type of adverse clinical events

  100 days

Secondary Outcomes (4)

• RA-18C3 pharmacokinetics

  70 days

• Facial acne lesion count

  56 days

• Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts

  56 days

• Investigator's Global Assessment (IGA) score

  56 days

Study Arms (1)

RA-18C3

EXPERIMENTAL

Drug: RA-18C3

Interventions

RA-18C3 DRUG

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.

RA-18C3

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Moy, Fincher, and Chipps Facial Plastics and Dermatology

Beverly Hills, California, 90210, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Austin Dermatology Associates

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

bermekimab

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Michael D Stecher, MD

  XBiotech USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: February 29, 2012
• Primary Completion: October 31, 2012
• Study Completion: December 31, 2012
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (3)