Sjögren's SyndromePhase 2NCT07118241

A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE

A Phase 2 study testing Recombinant Human Proteoglycan 4 in people with Sjögren's Syndrome, run by Lubris Bio Pty Ltd at 7 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Sjögren's Syndrome
What is being tested?: Recombinant Human Proteoglycan 4
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 7 sitesAustralia
Study dates: 17 Sep 2025to Mar 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have the ability to comprehend and provide a signed and dated consent form.
Are 18-75 years at time of consent;
Have been diagnosed with SS for at least 3 months prior to ICF;
Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
Have been stably using systemic medications for at least one month prior to Visit 1;
Have Global SANDE score ≥ 40;

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Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none < 5 mm;
Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \& OS both ≥ 1 and ≤ 2);
Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study.
Ability to self-administer study medication and willingness to adhere to the medication regimen.

Who cannot join

Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;
Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous/serum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;
Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.
Have only one eye;
Are unwilling to adhere to t.i.d. administration of vehicle during run-in;
Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;

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Have begun regularly using systemic compounds for SS or SS-related dry eye during the one month prior to Visit 1. Systemic compounds include omega-3 oil (fish oil, flaxseed oil, etc.), systemic corticosteroids, immunosuppressants, and biologics that based on investigator judgment will interfere with the interpretation of the study results.
Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;
Have known hypersensitivity to one of the components of the study or procedural medications;
Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;
Have a history of drug, medication or alcohol abuse or addiction;
Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:
are currently pregnant or,
have a positive result on the urine pregnancy test at the Screening Visit or,
intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,
are breast-feeding or,
not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods;
Are males with a female partner of child bearing potential where:
the male is not surgically sterilized or,
where the male partner cannot provide information regarding the female partner's child bearing status or,
where the child bearing status of the female partner does not meet that of Exclusion Criteria 12; however, the female partner of a male participant will not be required meet Exclusion Criteria 12b.
Have a history of a serious physical or psychiatric disorder that, in the investigator's opinion, could prevent compliance with study procedures or affect study participation;
Have any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Edward CEO contact

6193394016

etruitt@lubris.net

City, postcode or hospital

Sites recruiting now only

7 sites in 1 country

Australia7 sites, 7 recruiting

OTA
Brisbane, Queensland
Mark Hinds, 61 7 3608 2074, mark@ot-au.com
Recruiting
Queensland University of Technology
Brisbane, Queensland
Katie Clinical Trial Coordinator, +61 07 3138 6154, katie.edwards@qut.edu.au
Recruiting
University of the Sunshine Coast
Maroochydore, Queensland
Tanya Clinical Trial Coordinator, +61 7 5443 3211, revell@usc.edu.au
Recruiting
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Elaine, Assistant Professor, +61 413 668 695, Eyetrials@mh.org.au
Recruiting
University of Melbourne
Melbourne, Victoria
Laura Professor, +61 3 9035 3043, ldownie@unimelb.edu.au
Recruiting
Sydney Eye Hospital
Sydney, New South Wales
Stephanie Watson, +61 2 9382 7286, stephanie.watson@sydney.edu.au
Not yet recruiting
Univ of New South Wales
Sydney, New South Wales
Jackie Professor, +61 02 9385 6551, jacqueline.tan@unsw.edu.au
Recruiting

Other trials in Australia

About this study

rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.

Conditions: Sjögren's Syndrome
Being tested: Recombinant Human Proteoglycan 4, Vehicle Control
Keywords: Sjogrens Syndrome, Dry Eye
Medical subject headings: Sjogren's Syndrome, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Human Proteoglycan 4Drug
rhPRG4 450ug/ml
Vehicle ControlDrug
PBS based Vehicle Conrtol

Study groups in NCT07118241
Study group	Role	What they receive
Vehicle Control	Placebo comparator	PBS Based Vehicle Control Receives: Drug: Vehicle Control
rhPRG4 450ug/ml	Experimental	rhPRG4 450ug/ml Receives: Drug: Recombinant Human Proteoglycan 4

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
Measured: From baseline to the end of treatment at day 28

Secondary outcomes (7)

To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency & Corneal neo
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency \& Corneal neovascularization)
Measured: From baseline to day 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Measured: From baseline to day 28
To assess the efficacy of rhPRG4 using the total VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) at Day 28
To assess the efficacy of rhPRG4 using the total VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none \& severe) at Day 28
Measured: From baseline to day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle at Day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle at Day 28
Measured: From baseline to day 28
To assess the efficacy of rhPRG4 using the Oxford staining score, both per eye and as a total score per subject compared to vehicle at Day 28
To assess the efficacy of rhPRG4 using the Oxford staining score, both per eye and as a total score per subject compared to vehicle at Day 28
Measured: From baseline to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 2025Mar 2027

First posted12 Aug 2025
Study start17 Sep 2025
Primary completion30 Dec 2026 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07118241
Sponsor's protocol ID: RHPRG4-SJÖGREN'S-002
Status last verified: Oct 2026
First submitted: 5 Aug 2025
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Edward CEO

6193394016

etruitt@lubris.net

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Sjögren's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
ClinicalTrials.gov ID: NCT07118241
Acronym / sponsor ID: RHPRG4-SJÖGREN'S-002
Conditions: Sjögren's Syndrome
Keywords: Sjogrens Syndrome, Dry Eye
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Lubris Bio Pty LtdIndustry (pharma, biotech, devices)
Study start: 17 Sep 2025 (actual)
Primary completion: 30 Dec 2026 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 12 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vehicle Control	Placebo comparator	Drug: Vehicle ControlPBS Based Vehicle Control
rhPRG4 450ug/ml	Experimental	Drug: Recombinant Human Proteoglycan 4rhPRG4 450ug/ml

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Have the ability to comprehend and provide a signed and dated consent form.
Are 18-75 years at time of consent;
Have been diagnosed with SS for at least 3 months prior to ICF;
Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;
Have been stably using systemic medications for at least one month prior to Visit 1;

Key exclusion criteria (23 listed)

Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;
Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous/serum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;
Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.
Have only one eye;
Are unwilling to adhere to t.i.d. administration of vehicle during run-in;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Human Proteoglycan 4rhPRG4 450ug/ml	Drug	rhPRG4 450ug/ml
Vehicle ControlPBS based Vehicle Conrtol	Drug	Vehicle Control

Primary outcome

To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28
Time frame: From baseline to the end of treatment at day 28
To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28

7 secondary outcomes

To assess the safety of rhPRG4 by observation of the severity of treatment-emergent adverse events for the study duration
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of the change in BCVA over 28 days
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of signs evaluated by slit lamp examination (SLE) (Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Hyperemia, Corneal transparency & Corneal neo
Time frame: From baseline to day 28
To assess the safety of rhPRG4 by observation of intraocular pressure (IOP)
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the total VAS score for dryness, foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision and photophobia (anchors: none & severe) at Day 28
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the SANDE score compared to vehicle at Day 28
Time frame: From baseline to day 28
To assess the efficacy of rhPRG4 using the Oxford staining score, both per eye and as a total score per subject compared to vehicle at Day 28
Time frame: From baseline to day 28

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Sjögren's Syndrome

Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
RecruitingPhase 3
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
Primary Sjogren's Disease
Active, not recruitingPhase 2
A Study of RSLV-132 in Females With Sjögren's Disease
Primary Sjögren Syndrome
Active, not recruitingPhase 3
A Randomized, Double-blind 2-arm, Followed by an Open-label 1-arm, NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.
Sjogrens Syndrome
Not yet recruitingPhase 1
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
Systemic Lupus Erythematosus, Sjögren's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Edward CEO contact

6193394016

etruitt@lubris.net

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Human Proteoglycan 4 in people with Sjögren's Syndrome, run by Lubris Bio Pty Ltd at 7 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edward CEO (6193394016, etruitt@lubris.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28 (time frame: From baseline to the end of treatment at day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.