Phase 2
N=12
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
Non-infectious Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT03634475 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PP-001 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Panoptes Pharma GmbH
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events |
12 | — |
Summary
In this study, PP-001 is assessed for safety and efficacy in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 will be administered to participants as a single intravitreal injection in ascending doses.
Eligibility Criteria
Inclusion Criteria
- Male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis
Exclusion Criteria
- Patients receiving specific medication/interventions as specified per protocol
- Pregnant or nursing patients
Data sourced from ClinicalTrials.gov (NCT03634475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.