Acne VulgarisPhase 2NCT01474798
Phase II Trial of RA-18C3 in Subjects With Moderate to Severe Acne Vulgaris
A Phase 2 study testing RA-18C3 in people with Acne Vulgaris, run by Janssen Research & Development, LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- RA-18C3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Feb 2012to 31 Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
- Participation in an investigational drug or device trial within 30 days prior to Screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Austin Dermatology Associates
Austin, Texas, 78705
Moy, Fincher, and Chipps Facial Plastics and Dermatology
Beverly Hills, California, 90210
Meridien Research
St. Petersburg, Florida, 33709
About this study
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
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
- Being tested
- RA-18C3
- Keywords
- Acne Vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RA-18C3Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| RA-18C3 | Experimental | Not described Receives: Drug: RA-18C3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence and type of adverse clinical events
Measured: 100 days
Secondary outcomes (4)
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.
Measured: 70 days
Facial acne lesion count
Change in total facial acne lesion count from day 0 to week 8
Measured: 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
Measured: 56 days
Investigator's Global Assessment (IGA) score
Change in Investigator Global Assessment score from baseline to Day 56
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study start29 Feb 2012
- Primary completion31 Oct 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Stecher, MD, Study director, XBiotech USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474798
- Sponsor's protocol ID
- 2011-PT020
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2011
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01474798
- Acronym / sponsor ID
- 2011-PT020
- Conditions
- Acne Vulgaris
- Keywords
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2012 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA-18C3 | Experimental | Drug: RA-18C3 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: ≥ 18
- Moderate to moderately severe inflammatory acne vulgaris:
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RA-18C3For 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. | Drug | RA-18C3 |
Primary outcome
Safety and tolerability
Time frame: 100 days
Incidence and type of adverse clinical events
4 secondary outcomes
RA-18C3 pharmacokinetics
Time frame: 70 days
Facial acne lesion count
Time frame: 56 days
Reduction in total acne lesion count, inflammatory and non-inflammatory lesion counts
Time frame: 56 days
Investigator's Global Assessment (IGA) score
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Stecher, MD study director
XBiotech USA, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RA-18C3 in people with Acne Vulgaris, run by Janssen Research & Development, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.