A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

• ClinicalTrials.gov Identifier: NCT05042609
• Recruitment Status: Active, not recruiting
• First Posted: September 13, 2021
• Last Update Posted: April 18, 2023
• Sponsor: Tarsier Pharma
• Information provided by (Responsible Party): Tarsier Pharma

Tracking Information

• First Submitted Date: September 3, 2021
• First Posted Date: September 13, 2021
• Last Update Posted Date: April 18, 2023
• Actual Study Start Date: September 20, 2021
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2022)

Anterior Chamber Cell (ACC) grade on Day 28 [ Time Frame: 28 days ]

For FDA submission: the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. For submission to European Medicines Agency (EMA) related countries: the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.

Original Primary Outcome Measures (submitted: September 3, 2021)

Anterior Chamber Cell (ACC) grade on Day 28 [ Time Frame: 28 days ]

In the US, the proportion of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. In Europe, the proportion of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.

Current Secondary Outcome Measures (submitted: January 5, 2022)

• Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye [ Time Frame: 28 days ]
• Anterior Chamber Cell (ACC) grade on Day 21 [ Time Frame: 21 days ]
  For FDA submission: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. For submission to EMA related countries: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye.
• Change from baseline in ACC Grade on Day 21. [ Time Frame: 21 days ]

Original Secondary Outcome Measures (submitted: September 3, 2021)

• Anterior Chamber Cell (ACC) grade on Day 21 [ Time Frame: 21 days ]
  In the US: Proportion of subjects with ACC Grade=0 on Day 21 in the study eye. In the EU: Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye.
• Change from baseline (Day 1) in ACC Grade on Day 28 in the study eye [ Time Frame: 28 days ]
• Change from baseline (Day 1) in ACC Grade on Day 21 in the study eye [ Time Frame: 21 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
• Official Title: A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
• Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Non-infectious Anterior Uveitis
• Uveitic Glaucoma

Intervention

• Drug: TRS01
  TRS01 eye drops Dosed four times a day (QID)
• Drug: FDA approved steroid eye drop
  FDA approved steroid eye drop Dosed four times a day (QID)

Study Arms

• Experimental: TRS01
  Intervention: Drug: TRS01
• Active Comparator: Active comparator
  Intervention: Drug: FDA approved steroid eye drop

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 3, 2021): 162
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the EU: Male or female between 18 and 70 years of age, inclusive.
• Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
• Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).

Exclusion Criteria:

• Pregnant or breastfeeding females or females.
• History of or active significant ocular disease in either eye.
• Uncontrolled intraocular pressure (IOP; defined as >27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
• Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
• Cancer or melanoma that is actively treated with immunotherapy.
• Certain clinically significant systemic diseases or conditions.
• Receiving specific medication/interventions as specified per protocol.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 0 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, United States

Administrative Information

• NCT Number: NCT05042609
• Other Study ID Numbers: TRS4Vision
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tarsier Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: Tarsier Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Lexitas Clinical Trials; Lexitas

• PRS Account: Tarsier Pharma
• Verification Date: October 2022