Uveitis, PosteriorPhase 3CLARITYNCT06431373
A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis
A Phase 3 study testing Brepocitinib PO QD in people with Uveitis, Posterior and Uveitis, Intermediate, run by Priovant Therapeutics, Inc. at 107 sites in 13 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Intermediate, Uveitis
- What is being tested?
- Brepocitinib PO QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 371 participants
- Where
- 107 sitesin 13 countries
- Study dates
- 11 Sep 2024to 1 Feb 2028
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18-75 years old)
- Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
- Active uveitic disease in at least 1 eye
- Weight > 40 kg with a body mass index ≤ 40 kg/m2
Who cannot join
- Has confirmed or suspected current diagnosis of infectious uveitis History of or have:
- Lymphoproliferative disorder
- active malignancy
- 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.)
- thrombosis or cerebrovascular ischemic event disease within the last 12 months
- a high risk for herpes zoster reactivation
- active or recent infections
Trial locations and contacts
107 sites in 13 countries.
107 sites in 13 countries
United States53 sites
Clinical Trial Site
Ann Arbor, Michigan, 48105
Clinical Trial Site
Aurora, Colorado, 80045
Clinical Trial Site
Austin, Texas, 78712
Clinical Trial Site
Bakersfield, California, 93309
Clinical Trial Site
Baltimore, Maryland, 21287
Clinical Trial Site
Bellaire, Texas, 77401
Clinical Trial Site
Beverly Hills, California, 90211
Clinical Trial Site
Boston, Massachusetts, 02114
Clinical Trial Site
Carmel, Indiana, 46290
Clinical Trial Site
Chicago, Illinois, 60637
Clinical Trial Site
Cleveland, Ohio, 44106
Clinical Trial Site
Cleveland, Ohio, 44195
Clinical Trial Site
Columbus, Ohio, 43212
Clinical Trial Site
Dallas, Texas, 75390
Clinical Trial Site
Denver, Colorado, 80246
Clinical Trial Site
Detroit, Michigan, 48201
Clinical Trial Site
Detroit, Michigan, 48202
Clinical Trial Site
Durham, North Carolina, 27705
Clinical Trial Site
Erie, Pennsylvania, 16507
Clinical Trial Site
Fort Lauderdale, Florida, 33308
Clinical Trial Site
Fullerton, California, 92835
Clinical Trial Site
Greenville, South Carolina, 29605
Clinical Trial Site
Houston, Texas, 77025
Clinical Trial Site
Irvine, California, 92697
Clinical Trial Site
Katy, Texas, 77494
Clinical Trial Site
La Jolla, California, 92093
Clinical Trial Site
Los Angeles, California, 90033
Clinical Trial Site
Los Angeles, California, 90095
Clinical Trial Site
Madison, Wisconsin, 53705
Clinical Trial Site
Minneapolis, Minnesota, 55455
Clinical Trial Site
Modesto, California, 95356
Clinical Trial Site
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10017
Clinical Trial Site
Oak Park, Illinois, 60304
Clinical Trial Site
Omaha, Nebraska, 68105
Clinical Trial Site
Palisades Park, New Jersey, 07650
Clinical Trial Site
Philadelphia, Pennsylvania, 19107
Clinical Trial Site
Philadelphia, Pennsylvania, 19141
Clinical Trial Site
Phoenix, Arizona, 85020
Clinical Trial Site
Phoenix, Arizona, 85054
Clinical Trial Site
Plano, Texas, 75075
Clinical Trial Site
Portland, Oregon, 97221
Clinical Trial Site
Portland, Oregon, 97239
Clinical Trial Site
Prairie Village, Kansas, 66208
Clinical Trial Site
Rochester, Minnesota, 55905
Clinical Trial Site
Rochester, New York, 14642
Clinical Trial Site
Round Rock, Texas, 78681
Clinical Trial Site
Sacramento, California, 92825
Clinical Trial Site
San Antonio, Texas, 78230
Clinical Trial Site
St Louis, Missouri, 63108
Clinical Trial Site
St. Petersburg, Florida, 33711
Clinical Trial Site
Waltham, Massachusetts, 02451
Clinical Trial Site
Winston-Salem, North Carolina, 27157
United Kingdom12 sites
Clinical Trial Site
Birmingham, West Midlands, B18 7QH
Clinical Trial Site
Birmingham, B1S 2GW
Clinical Trial Site
Bradford, Yorkshire, BD9 6TB
Clinical Trial Site
Bristol, BS1 2LX
Clinical Trial Site
Liverpool, L7 8XP
Clinical Trial Site
London, England, EC1V 2PD
Clinical Trial Site
London, England, SE1 7EH
Clinical Trial Site
Maidstone, Kent, ME169QQ
Clinical Trial Site
Manchester, M13 9WL
Clinical Trial Site
Middlesbrough, North Yorkshire, TS4 3BW
Clinical Trial Site
Oxford, Oxfordshire, OX3 9DU
Clinical Trial Site
Sheffield, South Yorkshire, S10 2JF
Israel10 sites
Clinical Trial Site
Ashkelon, 7830604
Clinical Trial Site
Haifa, 3109601
Clinical Trial Site
Haifa, 3434104
Clinical Trial Site
Holon, 58101
Clinical Trial Site
Jerusalem, 9013102
Clinical Trial Site
Jerusalem, 9112001
Clinical Trial Site
Kfar Saba, 4428164
Clinical Trial Site
Poria – Neve Oved, 1528801
Clinical Trial Site
Tel Aviv, 6423906
Clinical Trial Site
Tel Aviv, 69710
Germany7 sites
Clinical Trial Site
Bonn, North Rhine-Westphalia, 53127
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, 40225
Clinical Trial Site
Kiel, 24105
Clinical Trial Site
Mainz, 55131
Clinical Trial Site
Mannheim, Baden-Wurttemberg, 68167
Clinical Trial Site
Münster, North Rhine-Westphalia, 48145
Clinical Trial Site
Münster, North Rhine-Westphalia, 48149
Argentina5 sites
Clinical Trial Site
Buenos Aires, 41076
Clinical Trial Site
Buenos Aires, C1015
Clinical Trial Site
Buenos Aires, C1061AAE
Clinical Trial Site
Buenos Aires, C1121
Clinical Trial Site
Rosario, Santa Fe Province, 41076
Spain5 sites
Clinical Trial Site
Barcelona, Catalonia, 08035
Clinical Trial Site
Barcelona, 08028
Clinical Trial Site
Madrid, 28-046
Clinical Trial Site
Madrid, 28040
Clinical Trial Site
Valladolid, 47011
Hungary4 sites
Clinical Trial Site
Budapest, Pest County, 01085
Clinical Trial Site
Budapest, 01133
Clinical Trial Site
Debrecen, Hajdú-Bihar, 04032
Clinical Trial Site
Pécs, Baranya, 07623
Italy4 sites
Clinical Trial Site
Milan
Clinical Trial Site
Perugia, Umbria, 06129
Clinical Trial Site
Reggio Emilia, 42123
Clinical Trial Site
Roma, 00184
Australia3 sites
Clinical Trial Site
East Melbourne, Victoria, 3002
Clinical Trial Site
Nedlands, Western Australia, 6009
Clinical Trial Site
Sydney, New South Wales, 2000
About this study
Official title: A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Uveitis
- Being tested
- Brepocitinib PO QD, Placebo PO QD
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brepocitinib PO QDDrug
Brepocitinib PO QD
Placebo PO QDDrug
Placebo PO QD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Brepocitinib PO QD |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo PO QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
Measured: 48 weeks
Secondary outcomes (5)
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24
Measured: 24 weeks
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24
Measured: 24 weeks
Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24
Measured: 24 weeks
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48
Measured: 48 Weeks
Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start11 Sep 2024
- Primary completion11 Sep 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priovant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431373
- Sponsor's protocol ID
- PVT-2201-303
- Acronym
- CLARITY
- Status last verified
- Dec 2025
- First submitted
- 22 May 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis
- ClinicalTrials.gov ID
- NCT06431373
- Acronym / sponsor ID
- CLARITY / PVT-2201-303
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Priovant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 11 Sep 2026 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 28 May 2024 (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.
The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Brepocitinib PO QD |
| Arm 2 | Placebo comparator | Drug: Placebo PO QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult subjects (18-75 years old)
- Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
- Active uveitic disease in at least 1 eye
- Weight > 40 kg with a body mass index ≤ 40 kg/m2
Key exclusion criteria (7 listed)
- Lymphoproliferative disorder
- active malignancy
- 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.)
- thrombosis or cerebrovascular ischemic event disease within the last 12 months
- 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 |
|---|---|---|
| Brepocitinib PO QDBrepocitinib PO QD | Drug | Arm 1 |
| Placebo PO QDPlacebo PO QD | Drug | Arm 2 |
Primary outcome
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48
Time frame: 48 weeks
5 secondary outcomes
Proportion of participants meeting treatment failure criteria on or after Period 1 Week 6 up to Period 1 Week 24
Time frame: 24 weeks
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 24
Time frame: 24 weeks
Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 24
Time frame: 24 weeks
Change in logMAR BCVA in each eye from best state achieved at or prior to Period 1 Week 6 up to Period 1 Week 48
Time frame: 48 Weeks
Change in central subfield thickness from best state achieved in each eye at or prior to Period 1 Week 6 up to Period 1 Week 48
Time frame: 48 weeks
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 12 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
107 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brepocitinib PO QD in people with Uveitis, Posterior and Uveitis, Intermediate, run by Priovant Therapeutics, Inc. at 107 sites in 13 countries.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States, United Kingdom, Israel, Germany, Argentina and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Time to treatment failure on or after Period 1 Week 6 up to Period 1 Week 48 (time frame: 48 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 12 Jan 2026.