Pyoderma GangrenosumPhase 3NCT02326740
An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
A Phase 3 study testing gevokizumab and gevokizumab open-label in people with Pyoderma Gangrenosum, run by XOMA (US) LLC at 16 sites in 3 countries.
Trial summary
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- gevokizumab and gevokizumab open-label
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Dec 2014to Mar 2016
- Phase
- Phase 3
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of classic pyoderma gangrenosum
- An active pyoderma gangrenosum ulcer
- Contraceptive measures adequate to prevent pregnancy during the study
Who cannot join
- Clinical evidence of acutely infected pyoderma gangrenosum
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of recurrent or chronic systemic infections
- Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States7 sites
Study site
Henderson, Nevada
Study site
Macon, Georgia
Study site
Oceanside, California
Study site
Rochester, New York
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
The Bronx, New York
Australia7 sites
Study site
Benowa, Queensland
Study site
Fremantle
Study site
Parkville, Victoria
Study site
St Leonards
Study site
Sydney
Study site
Westmead
Study site
Woolloongabba, Queensland
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).
- Conditions
- Pyoderma Gangrenosum
- Being tested
- gevokizumab, Placebo, gevokizumab open-label
- Keywords
- Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gevokizumabDrug
PlaceboDrug
gevokizumab open-labelDrug
| Study group | Role | What they receive |
|---|---|---|
| gevokizumab | Experimental | Solution for subcutaneous injection (Part 1, Group B) Receives: Drug: gevokizumab |
| Placebo | Placebo comparator | Solution for subcutaneous injection (Part 1, Group A) Receives: Drug: Placebo |
| gevokizumab open-label | Experimental | Solution for subcutaneous injection (Part 2, Open-label) Receives: Drug: gevokizumab open-label |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
Measured: Day 126
Secondary outcomes (1)
The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
Measured: Day 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 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
- NCT02326740
- Sponsor's protocol ID
- X052173
- Status last verified
- Apr 2016
- First submitted
- 22 Dec 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes