Participate in a clinical trial - University of the Sunshine Coast, Queensland, Australia

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Participate in a clinical trial

USC Clinical Trials is closely monitoring the evolving situation with the COVID-19 pandemic. Information about USC Clinical Trials' response can be found here.

Clinical Trials Centre

Improving our community’s access to cutting-edge medicine.

USC Clinical Trials has locations in the Sunshine Coast and Moreton Bay regions. Please select a location to view the studies available near you.

Ochre Health Medical Centre
Sunshine Coast

View clinical trials at our Sippy Downs clinic and various partner institutions around the Sunshine Coast.

Moreton Bay

View clinical trials at our Morayfield clinic, a dedicated clinical trial facility with a focus on early phase studies.

Healthy Volunteers

If you're healthy with no significant medical conditions, register your interest here to participate in future Healthy Volunteer studies.

Active studies - Recruiting now
  • Advanced Cancer
  • Dry Eye Disease
  • Malaria (healthy volunteers)
  • Healthy Volunteer studies
  • Presbyopia
  • Ulcerative Colitis
Upcoming studies - Recruiting Soon For These Indications
  • Atopic Dermatitis
  • Coronavirus Treatment
  • Healthy Volunteer Studies
  • Lymphodoema
  • Melanoma
  • Myelofibrosis
  • Plaque Psoriasis
  • Ulcerative Colitis
  • Vaccines (various)

When available, the results of studies completed by USC Clinical Trials are listed below.

Respiratory
Protocol Number Protocol Results Available?
205715 A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma

Media Release

Results Available

200812 A Phase III, 4-week, randomised, double-blind study to compare ‘closed’ triple therapy (FF/UMEC/VI), 'open' triple therapy (FF/VI + UMEC) and dual therapy (FF/VI) in subjects with chronic obstructive pulmonary disease (COPD) Results Available
RTB-101-204 A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Symptomatic Respiratory Illness Associated with Laboratory-Confirmed Pathogens in the Elderly Results Pending
FBP-001 A phase I/II study of povidone-iodine nasal spray (“Nasodine”) to investigate safety and tolerability in healthy volunteers (Stage 1), and to investigate safety and efficacy in patients with the common cold (Stage 2). Results Pending
FBP-002 A phase III study of the safety and efficacy of povidone-iodine nasal spray (“Nasodine”) in the treatment of subjects with the common cold in the natural setting. Results Pending
Devices
Protocol Number Protocol Results Available?
FLU-AUS-1701 A Prospective Multi-Centre Study of the ellume·lab Flu A+B Test and iTreat Flu A+B Flu Test Performance versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction. Results Pending
RESP16001 A PROSPECTIVE MULTI-CENTRE STUDY OF THE RESPIRIO FLU TEST AND eLab FLU TEST PERFORMANCE VERSUS REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION (RT-PCR) FOR THE RAPID DETECTION OF INFLUENZA A/B. Results Pending
GAS-AUS-1701 A PROSPECTIVE MULTI-CENTRE STUDY OF THE PERFORMANCE OF THE ELLUME·LAB GROUP A STREP TEST VERSUS CULTURE FOR THE RAPID DETECTION OF GROUP A STREPTOCOCCUS IN PARTICIPANTS WITH ACUTE PHARYNGITIS Results Pending
Inflammatory Bowel Diseases
Protocol Number Protocol Results Available?
RPC01-3202 INDUCTION STUDY #2 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Results Pending
GS-US-419-3895 Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease Results Pending
GS-US-419-3896 A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease Study Ongoing
GA29144 A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE Study Ongoing
GA29145 AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 Study Ongoing
GS-US-418-3898 Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis Results Pending
GS-US-418-3899 A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis Results Pending
Opthalmology
Protocol Number Protocol Results Available?
SHP640-301 A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640(PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis Results Pending
SHP640-303 A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640(PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis Results Available
P2-868963_001 A Multicenter, Prospective, Randomized, Double- Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients with Pterygium

Preliminary Media Release

Results Pending

Heart & Cardiovascular
Protocol Number Protocol Results Available?
1002-043 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT

Preliminary Media Release

Results Pending

1245-0167 A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF) (EMPERIAL – preserved) Results Pending
1245-0168 A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF) (EMPERIAL – reduced)

Preliminary Media Release

Results Pending

AROAPOC31001 A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-APOC3 in Adult Healthy Volunteers as well as in Severely Hypertriglyceridemic Patients and Patients with Familial Chylomicronemia Syndrome

Study Ongoing

Haematology
Protocol Number Protocol Results Available?
BIVV009-03 A PHASE 3 PIVOTAL, OPEN-LABEL,MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION Results Pending
BIVV009-04 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION Study Ongoing
Vaccines
Protocol Number Protocol Results Available?
V160-002 Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multi-center Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of a 2-Dose and a 3- Dose Regimen of V160 (Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative Women, 16 to 35 Years of Age Results Pending
FLU009 A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults aged 18 years and over

Preliminary Media Release

Results Pending

P2-868963_001 A Multicenter, Prospective, Randomized, Double- Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients with Pterygium

Preliminary Media Release

Results Pending

V199_04 A Phase IIIb-IV, Multicentre, Randomised, Open-label Study to Characterise the Reactogenicity of Afluria Quad Junior in Children 6 Months to Less Than 3 Years, and Afluria Quad in Children 3 Years to Less Than 9 Years Across Three Influenza Seasons

Study Ongoing

2019nCoV-101 A 2-PART, PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A
SARS-CoV-2 RECOMBINANT SPIKE PROTEIN NANOPARTICLE VACCINE (SARS-CoV-2 rS) WITH OR WITHOUT MATRIX-M™ ADJUVANT IN HEALTHY SUBJECTS

Recruitment Finished, study ongoing

Cosmetics
Protocol Number Protocol Results Available?
MT14-AU18GBL208 Phase II, Randomized, Double-Blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Glabellar Lines Study Ongoing
MT14-AU18LCL209 Phase , Randomized, Double-Blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines Study Ongoing
Arthritis
Protocol Number Protocol Results Available?
ZYN2-CL-005 A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multiple Center, Multiple-Dose Study to Assess the Efficacy and Safety of ZYN002 Administered as a Transdermal Gel to Patients with Knee Pain due to Osteoarthritis Results Pending
Sub-001 A Randomised, Double-blind, Placebo Controlled Study to Investigate the Efficacy on Pain Reduction and Safety of Swisse High Strength Deep Sea Krill Oil (Superba BOOST) in Adults with Mild to Moderate Osteoarthritis of the Knee Results Pending
Epilepsy
Protocol Number Protocol Results Available?
ZYN2-CL-03 A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, Multiple-Dose Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Patients with Partial Onset Seizures, Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy (STAR 1) Results Pending
ZYN2-CL-004 Open Label Extension Study to ZYN2-CL-03 to Assess the Long Term Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Patients with Partial Onset Seizures (STAR 2) Results Pending
Dietary & Metabolic Intolerances
Protocol Number Protocol Results Available?
Nexvax2-1005 A BIOEQUIVALENCE STUDY OF NEXVAX2 IN HLA-DQ2.5+ ADULTS WITH CELIAC DISEASE

Media Release

Results Pending

Nexvax2-2006 A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN HLA-DQ2.5+ ADULTS WITH CELIAC DISEASE TO ASSESS THE EFFECT OF NEXVAX2 ON SYMPTOMS AFTER MASKED GLUTEN FOOD CHALLENGE

Study Closure Notification

Results Pending

CDX6114-002 A Phase 1, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of CDX-6114 in Patients with Phenylketonuria (PKU).

Study Ongoing

Clinical Trial Partner Sites

USC Clinical Trials works with partner sites that run separate, specialised studies. These studies are not administered by USC Clinical Trials. Please contact the site directly if you are interested in one of these studies.

Coast Joint Care - Rheumatology Research Unit

To see if you are eligible for these studies, please call the Rheumatology Research Unit on 07 5443 1033.

Giant Cell Arteritis
Do you have a Diagnosis of Giant Cell Arteritis?

USC A/Professor David Nicholls and the Rheumatology Research Unit are researching whether a drug called sarilumab is safe and effective in treating Giant Cell Arteritis (GCA). As part of this trial, we are also investigating if the duration of corticosteroids intake (current standard treatment for GCA) can be reduced when sarilumab is co-administered, in order to reduce their side-effects.

Currently recruiting:

  • Adults over 50 years of age
  • Who are newly diagnosed with GCA or have persisting symptoms despite current medications

Full title: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis. Protocol EFC15068

Polymyalgia Rheumatica
Do you have a Diagnosis of Polymyalgia Rheumatica?

USC A/Professor David Nicholls and the Rheumatology Research Unit are researching whether a drug called sarilumab is safe and effective in treating Polymyalgia Rheumatica. The current primary treatment is corticosteroids which often results in side-effects when taken long-term. As part of this trial, we are also investigating if the duration of corticosteroid intake can be reduced when sarilumab is co-administered.

Currently recruiting:

  • Adults aged 50 or over at time of diagnosis
  • Who are newly diagnosed with PMR or who have persisting symptoms despite current medications

Full title: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica. Protocol EFC15160

Coastal Digestive Health

Crohn's Disease
Do you have Crohn's Disease?

This is a clinical trial of an investigational product for induction and maintenance of remission of moderately to severely active Crohn’s Disease, to be conducted by the University of the Sunshine Coast (QLD) in partnership with Coastal Digestive Health.

To see if you are eligible please call USC Clinical Trials Sippy Downs on 07 5456 3797

Full title: Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

As a clinical trials participant, your safety and comfort are our highest priorities. We are committed to keeping you informed throughout the entire clinical trial experience, so you can make informed decisions about the management of your health.

This includes:

  • An informed consent process, where all relevant information is provided to you prior to making a decision.
  • The opportunity for an in-depth discussion with your health provider (for example, GP or specialist) as well as the medical researchers undertaking the trial, before you commence the trial.
  • The ability to leave a clinical trial at any time, with no obligation to remain in a trial if you no longer wish to participate.
  • The ability to discuss results from any tests performed.
  • A summary of the results at the completion of the trial.

Common questions about clinical trials

Who should I speak to about whether clinical trials are right for me?

Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor. Ask questions about anything that you do not understand or want to know more about. A participant information sheet or consent form will be provided to you and tells you about the research project. It explains the tests and treatments involved. Knowing what is involved will help you decide if you want to take part in the research. Participation in research is voluntary. If you do not wish to take part, you do not have to. You will receive the best possible care whether or not you take part.

How do I know these trials are properly conducted and approved?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). Projects carried out by USC will be conducted according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.

What is placebo and what happens if I get the placebo?

A placebo is a medication with no active ingredients or a procedure without any medical benefit. It looks like the real thing but it is not. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

What are the benefits to me in participation?

We cannot guarantee or promise that you will receive any benefits from clinical research. For further information please read the Consumer Guide to Clinical Trials.

Are trials safe? People often say trials are guinea pig experiments?

Medical treatments often cause side effects. You may have none, some or all of the effects listed for a specific clinical trial, and they may be mild, moderate or severe. If you have any of these side effects, or are worried about them, talk with your study doctor. Your study doctor will also be looking out for side effects.

What if something goes wrong?

If you suffer any injuries or complications as a result of the research project, you should contact the study team as soon as possible and you will be assisted with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

Do I pay to participate or will I get paid?

There are no additional costs associated with participating in a research project, nor will you be paid. All medication, tests and medical care required as part of the research project will be provided to you free of charge. You may be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project visit.

What If I change my mind about participation?

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.

More information

The National Health and Medical Research Council and the Department of Industry and Science have developed a Consumer Guide to Clinical Trials, which provides general information about clinical trials for consumers, health care providers, researchers and industry.

This information has been made available with permission from the Consumer Health Forum of Australia.

Established in 2014, the USC Clinical Trials is delivering ethical, expert research across a range of therapeutic areas. Working with a network of qualified medical practitioners in public, private and independent practices, we aim to create a hub of clinical research capabilities across the Sunshine Coast and Moreton Bay regions, and increase the therapeutic options available to clinicians and their patients.

Referring patients

We encourage all trial participants to maintain routine visits with their referring physician, and are committed to the timely and effective sharing of progress reports and health outcomes.

To discuss a patient’s eligibility or for more information please contact us.

Work with us

Each clinical trial requires an expert and committed team, including:

  • the Principal Investigator, who is accountable for the conduct of the trial, recruitment and safety of all participants
  • co-Investigator(s), who are medically qualified and provide medical support and expertise to the principal investigator
  • clinical research coordinator(s) who are trained in clinical research (from a nursing, science, pharmacy or health-related background) and provide project management, recruitment and administrative support

We welcome expressions of interest from medically qualified individuals who are experienced or specialising in a specific therapeutic area, and are interested in partnering on a clinical trial. The USC Clinical Trials can provide full training and certification in GCP (online) and meet any other clinical trial training needs.

If you are a clinical trial professional, coordinator or trainee please get in touch to express your interest in working with us.