Acne VulgarisPhase 2NCT01498874
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris
A Phase 2 study testing gevokizumab in people with Acne Vulgaris, run by XOMA (US) LLC at 19 sites in United States.
Trial summary
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2011to Jun 2013
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of moderate to severe acne vulgaris
- Acne vulgaris unresponsive to oral antibiotics
- Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study
Who cannot join
- Use of medications or treatments from specified pre-treatment time periods through the end of the study
- Beard, moustache, sideburns or other facial hair that may interfere with evaluation
- Other forms of acne
- History of malignancy within 5 years
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of tuberculosis
Show all 9Show fewer
- History of chronic systemic infections
- Female subjects who are pregnant, planning to become pregnant
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Albuquerque, New Mexico
Study site
Arlington, Texas
Study site
Austin, Texas
Study site
Bay City, Michigan
Study site
Charlotte, North Carolina
Study site
Denver, Colorado
Study site
Fridley, Minnesota
Study site
High Point, North Carolina
Study site
Hot Springs, Arkansas
Study site
Houston, Texas
Study site
Las Vegas, Nevada
Study site
New Haven, Connecticut
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Riverside, California
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
South Euclid, Ohio
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Placebo, gevokizumab
- Keywords
- Acne, 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.
PlaceboDrug
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
gevokizumabDrug
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
gevokizumabDrug
Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| low dose gevokizumab | Experimental | Not described Receives: Drug: gevokizumab |
| high dose gevokizumab | Experimental | Not described Receives: Drug: gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Measured: Baseline and Day 84
Secondary outcomes (1)
The proportion of subjects with a successful treatment outcome at Day 84
Successful treatment outcome is defined as an improvement of >= 2 grades from the baseline grade on the dichotomized facial Investigator's Global Assessment scale.
Measured: Baseline and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionJun 2013
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498874
- Sponsor's protocol ID
- X052120
- Status last verified
- Mar 2014
- First submitted
- 21 Dec 2011
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01498874
- Acronym / sponsor ID
- X052120
- Conditions
- Acne Vulgaris
- Keywords
- Acne, Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Dec 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.
The purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| low dose gevokizumab | Experimental | Drug: gevokizumab |
| high dose gevokizumab | Experimental | Drug: gevokizumab |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of moderate to severe acne vulgaris
- Acne vulgaris unresponsive to oral antibiotics
- Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study
Key exclusion criteria (9 listed)
- Use of medications or treatments from specified pre-treatment time periods through the end of the study
- Beard, moustache, sideburns or other facial hair that may interfere with evaluation
- Other forms of acne
- History of malignancy within 5 years
- History of allergic or anaphylactic reactions to monoclonal antibodies
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 |
|---|---|---|
| PlaceboSterile solution administered subcutaneously on Day 0, Day 28, and Day 56 | Drug | Placebo |
| gevokizumabSterile solution administered subcutaneously on Day 0, Day 28, and Day 56 | Drug | low dose gevokizumab |
| gevokizumabSterile solution administered subcutaneously on Day 0, Day 28, and Day 56 | Drug | high dose gevokizumab |
Primary outcome
The mean absolute change from baseline in inflammatory facial lesion count at Day 84
Time frame: Baseline and Day 84
1 secondary outcome
The proportion of subjects with a successful treatment outcome at Day 84
Time frame: Baseline and Day 84
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 4 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 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 gevokizumab in people with Acne Vulgaris, run by XOMA (US) LLC at 19 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 3 inclusion and 9 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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. Some participants in this study may receive a placebo. 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?
The mean absolute change from baseline in inflammatory facial lesion count at Day 84 (time frame: Baseline and Day 84). 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 4 Mar 2014.