Phase 3 Uveitis Trial, Completed NCT05042609 Sponsor: Tarsier Pharma Condition: Uveitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05042609) enrolled 139 participants in total — 90 in the TRS01 group and 49 in the Active Comparator group. The trial was measuring eye inflammation, specifically looking at cells visible in the front part of the eye (called the anterior chamber) as a way to track how inflammation changed over 28 days. The main question the trial asked was how many participants had no detectable inflammation cells by Day 28. The reported data shows that by Day 28, 44 participants in the TRS01 group and 15 in the Active Comparator group had a complete absence of inflammation cells (a score of zero). When a slightly broader measure was used — counting either zero cells or only a trace amount — 52 participants in the TRS01 group and 42 in the Active Comparator group met that threshold at Day 28. For a secondary measure looking at the average change in inflammation score from the start of the trial to Day 28 (on a scale of 0 to 4, where 0 means no inflammation and 4 means severe), the TRS01 group showed an average decrease of 1.9 points, while the Active Comparator group showed an average decrease of 2.2 points. Similar patterns were also reported at Day 21, an earlier check-in point during the trial. The reported data also shows that at Day 21, 32 participants in the TRS01 group and 29 in the Active Comparator group had a complete absence of inflammation cells, while 50 and 40 participants respectively had either zero or trace-level cells. The average change in inflammation score from the start to Day 21 was a decrease of 1.7 points for TRS01 and 2.1 points for the Active Comparator group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Uveitis Trial, Completed

NCT05042609
Completed Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are male or female and up to 75 years old (if the trial site is in the US), or between 18 and 70 years old (if the trial site is in Europe).
  • You have been diagnosed with a specific type of active eye inflammation (non-infectious anterior uveitis) with a moderate level of inflammation in one eye, either without current treatment or with stable treatment that needs to be improved.
  • You have reasonably good vision (meeting a specific vision test score) in your eye that is not being studied.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have a history of, or currently have, a significant eye disease in either eye.
  • You have uncontrolled eye pressure (above a specific level) or a type of glaucoma called narrow angle glaucoma in either eye, or are at risk of a pressure-related eye problem when your pupils are dilated.
  • The back of your eye cannot be properly examined due to difficulty dilating your pupils or cloudiness inside the eye.
  • You have cancer or melanoma that is currently being treated with a type of therapy that works through the immune system.
  • You have certain serious health conditions or diseases affecting the rest of your body (confirm with trial site).
  • You are currently taking certain medications or receiving certain treatments as outlined in the study rules (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Sponsor
Tarsier Pharma
Registry
ClinicalTrials.gov
Start date
20 September 2021
Est. completion
29 June 2023

Where this trial is recruiting

🇫🇷 France 🇩🇪 Germany 🇺🇸 United States

Primary endpoints

Anterior Chamber Cell (ACC) Grade = 0 on Day 28; Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov