PsoriasisNCT07615712
PPD™ CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study
An observational study of Psoriasis, run by CorEvitas at 1 site in United States.
Trial summary
This is a 16-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Observational (Non-Interventional) Registry
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study population must be at least 18 years of age and is initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+/- 5 days), 4 (+/- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures.
Who may be able to join
- The inclusion criteria for this study will be as follows:
- Patient is at least 18 years of age at the time of study enrollment
- Patient has a diagnosis of moderate to severe plaque psoriasis based on an Investigator Global Assessment (IGA, part of routine care) score of 3 or 4 at the time of Enrollment.
- Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
- Patient is willing and able to provide informed consent to participate in this study.
- Patient is willing to be seen in-person by their treating dermatology provider at two (2), four (4), and sixteen (16) weeks following initiation of the advanced therapy.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in the study:
- Patient is participating in a blinded clinical trial.
- Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
- Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.
- Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.
- Patients otherwise meeting eligibility criteria can be enrolled in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study C. Following completion or at time of Exit from the CorEvitas Psoriasis (PSO) Rapid Response Non Interventional Study, patients will be eligible to enroll into the CorEvitas PSO Registry for long term follow up at the standard of care cadence supported by the registry. A separate Informed consent will be obtained.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CorEvitas, LLC
Waltham, Massachusetts, 02451
Cathy Cheney, 508-555-1212, corevitasregistrytrials@corevitas.com
508-555-1212, corevitasregistrytrials@corevitas.com
About this study
This is a 16-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+/- 5 days), 4 (+/- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 2, Week 4, and Week 16) using a structured and standardized data collection tool.
Read the detailed description
Data collected through the study may be used to address a range of research questions and use cases and objectives, including but not limited to study
- Creation of a cohort of psoriasis subjects to describe the clinical and patient-reported outcomes (PRO) and changes at 2,4, and 16 weeks after initiation of the advanced therapy.
- Inform clinical decision making by subjects and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the recording of medication utilization data.
- Describe subject characteristics (i.e. comorbidity, medication history, sociodemographic) at baseline.
- For subjects with a dermatologist-confirmed diagnosis of psoriatic arthritis at baseline, to describe the joint pain and patient wellness.
- Conditions
- Psoriasis
- Being tested
- Observational (Non-Interventional) Registry
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational (Non-Interventional) RegistryOther
This is an observational (non-interventional) registry
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a cohort of psoriasis subjects
Creation of a cohort of psoriasis subjects to describe the changes at 2,4, and 16 weeks after initiation of the advanced therapy.
Measured: Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start30 Apr 2025
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615712
- Sponsor's protocol ID
- CorEvitas-PSO-505
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPD™ CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study
- ClinicalTrials.gov ID
- NCT07615712
- Acronym / sponsor ID
- CorEvitas-PSO-505
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 29 May 2026 (actual)
- 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 16-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+/- 5 days), 4 (+/- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 2, Week 4, and Week 16) using a structured and standardized data collection tool.
Detailed description
Data collected through the study may be used to address a range of research questions and use cases and objectives, including but not limited to study
- Creation of a cohort of psoriasis subjects to describe the clinical and patient-reported outcomes (PRO) and changes at 2,4, and 16 weeks after initiation of the advanced therapy.
- Inform clinical decision making by subjects and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the recording of medication utilization data.
- Describe subject characteristics (i.e. comorbidity, medication history, sociodemographic) at baseline.
- For subjects with a dermatologist-confirmed diagnosis of psoriatic arthritis at baseline, to describe the joint pain and patient wellness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population must be at least 18 years of age and is initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+/- 5 days), 4 (+/- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures.
Key inclusion criteria (6 listed)
- Patient is at least 18 years of age at the time of study enrollment
- Patient has a diagnosis of moderate to severe plaque psoriasis based on an Investigator Global Assessment (IGA, part of routine care) score of 3 or 4 at the time of Enrollment.
- Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
- Patient is willing and able to provide informed consent to participate in this study.
- Patient is willing to be seen in-person by their treating dermatology provider at two (2), four (4), and sixteen (16) weeks following initiation of the advanced therapy.
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in the study:
- Patient is participating in a blinded clinical trial.
- Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
- Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.
- Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.
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 |
|---|---|---|
| Observational (Non-Interventional) RegistryThis is an observational (non-interventional) registry | Other | – |
Primary outcome
Creation of a cohort of psoriasis subjects
Time frame: Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy
Creation of a cohort of psoriasis subjects to describe the changes at 2,4, and 16 weeks after initiation of the advanced therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by CorEvitas at 1 site 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Psoriasis Rapid Response Study Team (6178655932, ppd_corepsoriasis@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a cohort of psoriasis subjects (time frame: Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy). 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 26 Aug 2026.