Non-infectious Intermediate UveitisPhase 2NEPTUNENCT05523765
A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis
A Phase 2 study testing Brepocitinib in people with Non-infectious Intermediate Uveitis and Non-infectious Posterior Uveitis, run by Priovant Therapeutics, Inc. at 15 sites in United States.
Trial summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis
- What is being tested?
- Brepocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 15 sitesUnited States
- Study dates
- 14 Nov 2022to 30 Jul 2024
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18-74 years old)
- Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
- Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator:
- Active, inflammatory chorioretinal and/or retinal vascular lesion; OR
- ≥2+ vitreous haze grade (NEI/SUN criteria).
- Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
- Weight > 40 kg with a body mass index < 40 kg/m2.
Who cannot join
- Has isolated anterior uveitis.
- Has confirmed or suspected current diagnosis of infectious uveitis
- History of:
- Any lymphoproliferative disorder
- Active malignancy;
- History of cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
Show all 10Show fewer
- At risk of thrombosis and cardiovascular disease
- Have a high risk for herpes zoster reactivation
- Have active or recent infections
- Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Clinical Trial Site
Bellaire, Texas, 77401
Clinical Trial Site
Durham, North Carolina, 27710
Clinical Trial Site
Eugene, Oregon, 97401
Clinical Trial Site
Katy, Texas, 77494
Clinical Trial Site
Lakewood, Colorado, 80228
Clinical Trial Site
Los Angeles, California, 90095
Clinical Trial Site
Nashville, Tennessee, 37203
Clinical Trial Site
Palisades Park, New Jersey, 07650
Clinical Trial Site
Palo Alto, California, 94303
Clinical Trial Site
Pasadena, California, 91107
Clinical Trial Site
Plano, Texas, 75075
Clinical Trial Site
Salt Lake City, Utah, 84107
Clinical Trial Site
St Louis, Missouri, 63110
Clinical Trial Site
Waltham, Massachusetts, 02451
Clinical Trial Site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active Non-Infectious Intermediate-, Posterior-, and Panuveitis
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).
- Conditions
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis
- Being tested
- Brepocitinib
- Keywords
- Brepocitinib, PF-06700841, uveitis, NIU
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrepocitinibDrug
Oral Brepocitinib
| Study group | Role | What they receive |
|---|---|---|
| Brepocitinib Dose Level 1 by mouth (PO) once daily (QD) | Experimental | Not described Receives: Drug: Brepocitinib |
| Brepocitinib Dose Level 2 by mouth (PO) once daily (QD) | Experimental | Not described Receives: Drug: Brepocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful.
Measured: Screening up to 28 days after the last dose of study drug at 52 weeks
Secondary outcomes (1)
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start14 Nov 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Intermediate UveitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priovant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brendan Johnson, PhD, Study director, SVP, Early Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523765
- Sponsor's protocol ID
- PVT-2201-201
- Acronym
- NEPTUNE
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Masked, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active Non-Infectious Intermediate-, Posterior-, and Panuveitis
- ClinicalTrials.gov ID
- NCT05523765
- Acronym / sponsor ID
- NEPTUNE / PVT-2201-201
- Conditions
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Pan Uveitis
- Keywords
- Brepocitinib, PF-06700841, uveitis, NIU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Priovant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 31 Aug 2022 (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 study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active intermediate, posterior, or pan non-infectious uveitis (NIU).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brepocitinib Dose Level 1 by mouth (PO) once daily (QD) | Experimental | Drug: Brepocitinib |
| Brepocitinib Dose Level 2 by mouth (PO) once daily (QD) | Experimental | Drug: Brepocitinib |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subjects (18-74 years old)
- Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis).
- Active uveitic disease as defined by the presence of at least 1 of the following parameters in at least 1 eye, as determined by the investigator:
- Receiving up to one non-corticosteroid, non-biologic, immunomodulatory therapy
- Weight > 40 kg with a body mass index < 40 kg/m2.
Key exclusion criteria (10 listed)
- Has isolated anterior uveitis.
- Has confirmed or suspected current diagnosis of infectious uveitis
- History of:
- At risk of thrombosis and cardiovascular disease
- Have a high risk for herpes zoster reactivation
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 |
|---|---|---|
| BrepocitinibOral Brepocitinib | Drug | Brepocitinib Dose Level 1 by mouth (PO) once daily (QD), Brepocitinib Dose Level 2 by mouth (PO) once daily (QD) |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to 28 days after the last dose of study drug at 52 weeks
Safety assessments will consist of monitoring and recording all adverse events (AEs) and SAEs, laboratory evaluation for hematology, blood chemistry, and urinalysis; vital signs; electrocardiograms (ECGs); and physical examinations. The investigator will determine whether the change is clinically meaningful.
1 secondary outcome
Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24
Time frame: 24 weeks
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 25 Jul 2025.
- Individual participant dataSharing planned: Yes. Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
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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.
Brendan Johnson, PhD study director
SVP, Early Development
15 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 Brepocitinib in people with Non-infectious Intermediate Uveitis and Non-infectious Posterior Uveitis, run by Priovant Therapeutics, Inc. at 15 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 7 inclusion and 10 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Screening up to 28 days after the last dose of study drug at 52 weeks). 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 25 Jul 2025.