Commercial Clinical Trials
Researchers are constantly looking for new and improved ways to diagnose, manage and treat diseases. It is important that these new methods or treatments are tested for their safety and effectiveness in humans – this is done by conducting research studies known as clinical trials. Our team aims to contribute to the advancement of medicine by participating in clinical trial programs which evaluate the latest developments in rheumatology.
The Commercial Clinical Trials stream includes research staff, research students and professional staff from a variety of backgrounds.
Prof Peter Youssef
Current research projects & trials
Evaluating the Effectiveness of Upadacitinib on Pain Control in Patients with Radiographic Axial Spondylarthritis
UPSTAND: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondyloarthritis This study will evaluate the effectiveness of Upadacitinib on early and sustained pain control in patients with radiographic axial spondyloarthritis in real world practice. This study will also explore the association between pain and clinical/patient-reported outcomes. Radiographic Axial Spondyloarthritis (r-axSpA) is an autoimmune disease which causes arthritis in the spine and pelvis. Patients have identified “pain” as their biggest unmet need in r-axSpA, and many report persistent pain, including back pain, which impacts disease activity and their quality of life. There is a lack of knowledge on pain in r-axSpA, including pain types, how it is localised and how these facets are impacted by treatment. There are currently no oral targeted therapies approved for the treatment of r-axSpA. Upadacitinib is an oral reversible inhibitor of Janus Kinase (JAK) which is an enzyme involved in inflammation. So far, there has only been one relatively small study looking at the therapeutic effect of Upadacitinib in patients with r-axSpA. Therefore, there is a need to obtain additional evidence on the impact of Upadacitinib on pain. This observational study will enroll patients that have been prescribed Upadacitinib by their treating physician. Participants will be followed up for one year and will be managed per routine clinical practice. Several patient-reported outcomes will also be collected electronically between visits and at routine clinical visits. This trial is now recruiting. This trial has received ethics approval from the Sydney Local Health District Human Research Ethics Committee (RPAH Zone). The sponsor of this trial is AbbVie Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATOR: Dr Bethan Richards (IMH; Rheumatology, RPAH) NCT04846244
Evaluating the Efficacy and Safety of BIIB059 in Participants With Active Systemic Lupus Erythematosus Receiving Nonbiologic Lupus Standard of Care (TOPAZ-1)
TOPAZ-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care The aim of this study is to investigate the effectiveness and safety of an investigational drug (BIIB059) in patients with active systemic lupus erythematosus, who are currently receiving treatment with background lupus standard of care therapy. Lupus is an autoimmune disease where the body’s immune system attacks itself, resulting in inflammation. Systemic lupus erythematosus (SLE) can affect many different parts of the body, but frequently involves the joints, skin, kidneys and blood cells. Most therapies used to treat SLE are only partially effective and have considerable toxicity. BIIB059 is a type of antibody developed to target certain cells thought to play a role in the development of lupus. Data from previous trials indicate that BIIB059 has the potential to decrease active lupus disease and control disease activity in SLE by inhibiting the production of some inflammatory mediators. Participants will be randomly assigned to one of three groups (placebo, BIIB059 225 mg or BIIB059 450 mg) and will receive these as subcutaneous (under the skin) injections every 4 weeks, up to a total of 52 weeks. This trial is now recruiting. This trial has received ethics approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee. The sponsor of this trial is Biogen Australia Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATOR: Dr Matthew Parker (Rheumatology, RPAH) NCT04895241
Previous research projects & trials
Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis
A Phase IIa, Double-Blind, Randomised, Intracohort Placebo-Controlled, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101 in Patients with Diffuse Cutaneous Systemic Sclerosis The aim of this trial is to evaluate the safety, tolerability and effectiveness of EHP-101 in patients with a specific type of systemic sclerosis (diffuse cutaneous systemic sclerosis). Systemic sclerosis is a chronic disease characterized by inflammation and scarring (fibrosis) of the skin and internal organs. There is currently no cure for systemic sclerosis and most treatments target the specific symptoms and problems caused by fibrosis in different parts and organs of the body. EHP-101 Liquid is a new experimental drug that has the potential to reduce inflammation and limit fibrosis in systemic sclerosis. EHP-101 is derived from cannabis (marijuana) but is made synthetically and has no addictive or psychological effects. This study will evaluate the safety and tolerability of EHP-101 compared to placebo in participants with diffuse cutaneous systemic sclerosis. Participants will be randomly allocated into groups to receive either placebo or EHP-101 liquid for 84 days, in addition to their existing medication. Recruitment for this trial has now closed. This trial has received ethics approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee. The sponsor of this trial is Emerald Health Pharmaceuticals Australia Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATORS: Dr Matthew Parker (Rheumatology, RPAH), Dr Angela Fu (Rheumatology, RPAH). NCT04166552
Safety and Effectiveness of ABBV-154 in Participants With Polymyalgia Rheumatica (PMR) Who Are Dependent on Glucocorticoids
Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of ABBV-154 The purpose of this study is to assess the safety and efficacy of ABBV-154 versus placebo in participants with polymyalgia rheumatica who are dependent on treatment with glucocorticoids. Polymyalgia rheumatica (PMR) is an inflammatory disorder that causes muscle pain and stiffness, particularly in the shoulders, hip and neck. Glucocorticoids, such as prednisone, are the primary treatment for PMR. While they are highly effective at reducing inflammation and relieving pain, their use is limited due to the systemic side effects which occur from long-term use. ABBV-154 is an anti-TNF antibody-drug-conjugate composed of adalimumab (the active component of Humira) conjugated to a glucocorticoid receptor modulator (GRM). This conjugate has been designed to deliver the anti-inflammatory payload GRM intracellularly, and it is hypothesised that this will allow for control of PMR disease activity. Participants will be randomly assigned to one of four treatment arms to receive either placebo or varying doses of ABBV-154, administered via subcutaneous injections every other week, up to a total of 52 weeks. Recruitment for this trial has now closed. This trial has received ethics approval from the South Metropolitan Health Service Human Research Ethics Committee. The sponsor of this trial is AbbVie Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATOR: Dr Matthew Parker (Rheumatology, RPAH) NCT04972968