Generalized Pustular PsoriasisNCT06100991
CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry
An observational study of Generalized Pustular Psoriasis, run by CorEvitas at 1 site in United States.
Trial summary
Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generalized Pustular Psoriasis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to Dec 2099
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are enrolled in the GPP Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.
Who may be able to join
- A subject must meet all the following criteria to participate in the registry:
- Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner.
- Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
- Is willing to provide consent for participation in the registry.
- Is willing to provide Personal Information
Who cannot join
- Any of the following would exclude the subject from participating in the registry:
- Is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.
- Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target
Read the detailed description
The objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of GPP for the purposes of clinical, market, or outcomes research.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
- Conditions
- Generalized Pustular Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Generalized Pustular Psoriasis (GPP) | Pts presenting to enrolling sites across the North America are invited to enroll if eligible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure:GPP epidemiology and Presentation
The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation and natural history.
Measured: Through study completion, an average of 10 years
GPP management, and outcomes
The major clinical outcome include an assessment of the epidemiology of GPP; to better understand the management and outcomes.
Measured: Through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start19 Sep 2023
- Primary completionDec 2099 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Pustular PsoriasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100991
- Sponsor's protocol ID
- CorEvitas GPP-510
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No