TerminatedPhase 1/2

RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)

Stopped: Efficacy signal substantial enough to more to larger study

Australia3 participantsStarted 2025-02-14

Plain-language summary

rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects 18 years of age or older;
. Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
. VAS Eye Dryness (100-point scale) score ≥ 60 mm;
. Tear Osmolarity ≥ 312 in either eye;
. Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
. Only subjects who satisfy all Informed Consent requirements may be included in the study.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28

Timeframe: 28

To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28

Timeframe: 28

To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events

Timeframe: 28

Trial details

NCT IDNCT06495307

SponsorLubris Bio Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-22

View on ClinicalTrials.gov More Ocular Graft-versus-host Disease trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects 18 years of age or older;
. Subjects diagnosed with oGVHD for at least 3 months (current use of artificial tears for the treatment of GVHD);
. VAS Eye Dryness (100-point scale) score ≥ 60 mm;
. Tear Osmolarity ≥ 312 in either eye;
. Corneal staining score with fluorescein ≥ 2 using the Oxford scale in the worst performing eye; staining must include quadrants beyond only inferior or superior staining;
. Only subjects who satisfy all Informed Consent requirements may be included in the study.

Exclusion criteria

What they're measuring

To assess the efficacy of rhPRG4 using the average VAS score assessing subjects' eye dryness (Question: Rate the dryness of your eye; anchors: 0 = no discomfort, 100 = maximal discomfort) at Day 28

Timeframe: 28

To assess the efficacy of rhPRG4 using the total corneal staining with fluorescein (Oxford Scale) at Day 28

Timeframe: 28

To assess the safety of rhPRG4 by observation of the frequency and severity of treatment-emergent adverse events

Timeframe: 28