Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022128-63 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX211 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX211 | Drug | Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio:
Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily mean systemic corticosteroid dose used during Weeks 12-24 | Weeks 12-24 | |
| Time to augmentation with corticosteroid therapy. | Week 24 |
Not provided
Inclusion Criteria:
Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.
Subjects must be:
Exclusion Criteria:
Ocular Disease/Conditions
The following conditions are exclusionary if present:
Prior and Current Treatment:
- As defined in the protocol
Extraocular Conditions:
- As defined in the protocol.
Laboratory, Blood Pressure and ECG Evaluations:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eddy Anglade, M.D. | Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peoria | Arizona | 85381 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phoenix |
| Arizona |
| 85014 |
| United States |
| Little Rock | Arkansas | 72205 | United States |
| Beverly Hills | California | 90211 | United States |
| Mountain View | California | 94040 | United States |
| Sacramento | California | 95819 | United States |
| Santa Ana | California | 92705 | United States |
| Torrance | California | 90503 | United States |
| Indianapolis | Indiana | 46290 | United States |
| Ellsworth | Maine | 04605 | United States |
| Baltimore | Maryland | 21287 | United States |
| Cambridge | Massachusetts | 02142 | United States |
| Newark | New Jersey | 07103 | United States |
| Belmont | North Carolina | 28012 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44122 | United States |
| Cleveland | Ohio | 44195 | United States |
| Dublin | Ohio | 43016 | United States |
| Middleburg Heights | Ohio | 44130 | United States |
| Ashland | Oregon | 97520 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Ladson | South Carolina | 29456 | United States |
| Arlington | Texas | 76012 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78240 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23219 | United States |
| Vienna | 1030 | Austria |
| Recife | 50070-040, PE | Brazil |
| Rio de Janeiro | 21941-913, RJ | Brazil |
| São Paulo | 04023-062, SP | Brazil |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Brno | 62500 | Czechia |
| Hradec Králové | 50005 | Czechia |
| Olomouc | 77520 | Czechia |
| Prague | 12808 | Czechia |
| Angers | 49933 | France |
| Bordeaux | 33000 | France |
| Paris | 75013 | France |
| Paris | 75019 | France |
| Münster | 48145 | Germany |
| Tübingen | 72076 | Germany |
| Bologna | 40138 | Italy |
| Milan | 20132 | Italy |
| Padova | 35128 | Italy |
| Parma | 43126 | Italy |
| Reggio Emilia | 42100 | Italy |
| Birmingham | B18 7QU | United Kingdom |
| London | EC1V 2PD | United Kingdom |
| London | SE1 7EH | United Kingdom |
| York | YO31 8HE | United Kingdom |