A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
1 other identifier
interventional
12
5 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2017
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 7, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
October 9, 2024
CompletedOctober 9, 2024
July 1, 2024
1.8 years
August 7, 2018
December 21, 2023
July 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events
To assess safety and tolerability of ascending doses of PP-001 in participants with chronic, non-infectious uveitis when administered as single intravitreal injection
40 days
Study Arms (1)
PP-001
EXPERIMENTALSingle intravitreal injection of 3 up to 4 doses of PP-001
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis
You may not qualify if:
- Patients receiving specific medication/interventions as specified per protocol
- Pregnant or nursing patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University Hospital Vienna
Vienna, Austria
University Hospital Leuven
Leuven, Belgium
Charité Berlin
Berlin, Germany
LMU Munich
Munich, Germany
University Hospital Muenster
Münster, Germany
University Hospital Tuebingen
Tübingen, Germany
Rotterdam Eye Hospital
Rotterdam, Netherlands
Bristol Eye Hospital
Bristol, United Kingdom
Moorefields Eye Hospital
Moorfields, United Kingdom
Related Publications (1)
Thurau S, Deuter CME, Heiligenhaus A, Pleyer U, Van Calster J, Barisani-Asenbauer T, Obermayr F, Sperl S, Seda-Zehetner R, Wildner G. A new small molecule DHODH-inhibitor [KIO-100 (PP-001)] targeting activated T cells for intraocular treatment of uveitis - A phase I clinical trial. Front Med (Lausanne). 2022 Oct 17;9:1023224. doi: 10.3389/fmed.2022.1023224. eCollection 2022.
PMID: 36325389DERIVED
Results Point of Contact
- Title
- Study Director
- Organization
- Panoptes Pharma
Study Officials
- STUDY DIRECTOR
Panoptes Study Director
Panoptes Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2018
First Posted
August 16, 2018
Study Start
January 1, 2017
Primary Completion
November 1, 2018
Study Completion
April 1, 2019
Last Updated
October 9, 2024
Results First Posted
October 9, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share