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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474798
• Other study ID #: 2011-PT020
• Status: Completed
• Phase: Phase 2
• Start date: February 29, 2012
• Est. completion date: December 31, 2012

Study information

• Verified date: February 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2012
• Est. primary completion date: October 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	Austin Dermatology Associates	Austin	Texas
United States	Moy, Fincher, and Chipps Facial Plastics and Dermatology	Beverly Hills	California
United States	Meridien Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Incidence and type of adverse clinical events	100 days
Secondary	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
Secondary	Facial acne lesion count	Change in total facial acne lesion count from day 0 to week 8	56 days
Secondary	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
Secondary	Investigator's Global Assessment (IGA) score	Change in Investigator Global Assessment score from baseline to Day 56	56 days