## Protocol Section
### Identification Module
**NCT ID:** NCT06431373

**Acronym:** CLARITY

**Brief Title:** A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (CLARITY)

**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

#### Organization Study ID Info
**ID:** PVT-2201-303
#### Organization
**Class:** INDUSTRY
**Full Name:** Priovant Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2027-08-23

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-08-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-23

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Priovant Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to determine the safety and efficacy (including corticosteroid-sparing effect) of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

### Conditions Module

**Conditions:**

- Uveitis, Posterior

- Uveitis, Intermediate

- Uveitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 220

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Brepocitinib 45 mg PO QD

**Label:** Arm 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo PO QD

**Label:** Arm 2

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm 1

**Description:** Brepocitinib 45 mg PO QD

**Name:** Brepocitinib 45 mg PO QD

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Arm 2

**Description:** Placebo PO QD

**Name:** Placebo PO QD

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Proportion of participants meeting treatment failure criteria on or after Week 6 up to Week 24

**Time Frame:** 24 weeks

#### Secondary Outcomes

**Measure:** Time to treatment failure on or after Week 6 up to Week 24

**Time Frame:** 24 weeks

**Measure:** Change in logarithm of the minimum angle of resolution (logMAR) best corrected visual acuity (BCVA) in each eye from best state achieved at Week 6 up to Week 24

**Time Frame:** 24 weeks

**Measure:** Change in central subfield thickness from best state achieved in each eye at or prior to Week 6 up to Week 24

**Time Frame:** 24 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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).
* Weight \> 40 kg with a body mass index \< 40 kg/m2.

Exclusion Criteria:

* Has isolated anterior uveitis.
* Has macular edema as the only sign of intermediate uveitis, posterior uveitis, or panuveitis.
* Has confirmed or suspected current diagnosis of infectious uveitis
* History of or have:

  1. ymphoproliferative disorder
  2. active malignancy;
  3. 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.)
  4. thrombosis and cardiovascular disease within the last 12 months
  5. a high risk for herpes zoster reactivation
  6. active or recent infections

**Maximum Age:** 74 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014603

- Term: Uveal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000015864

- Term: Panuveitis

- ID: D000002833

- Term: Choroiditis

- ID: D000015862

- Term: Choroid Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17353

- Name: Uveitis

- Relevance: HIGH

- As Found: Uveitis

- ID: M18410

- Name: Uveitis, Posterior

- Relevance: HIGH

- As Found: Uveitis, Posterior

- ID: M18411

- Name: Uveitis, Intermediate

- Relevance: HIGH

- As Found: Uveitis, Intermediate

- ID: M18408

- Name: Panuveitis

- Relevance: LOW

- As Found: Unknown

- ID: M18412

- Name: Pars Planitis

- Relevance: HIGH

- As Found: Uveitis, Intermediate

- ID: M17351

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6073

- Name: Choroiditis

- Relevance: LOW

- As Found: Unknown

- ID: M18406

- Name: Choroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4396

- Name: Panuveitis

- Relevance: LOW

- As Found: Unknown

- ID: T4439

- Name: Pars Planitis

- Relevance: HIGH

- As Found: Uveitis, Intermediate

- ID: T5824

- Name: Uveal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1187

- Name: Choroiditis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014605

- Term: Uveitis

- ID: D000015866

- Term: Uveitis, Posterior

- ID: D000015867

- Term: Uveitis, Intermediate

- ID: D000015868

- Term: Pars Planitis

### Misc Info Module

- Version Holder: 2024-05-31
