Please note the cohort for people with lupus has been filled. If you wish to register for future lupus trials, register here.

This trial is evaluating a potential new investigational treatment, designed to restore balance in the immune system in people with autoimmune or immune-mediated diseases, including rheumatoid arthritis, psoriatic arthritis, psoriasis, and atopic dermatitis. These conditions happen when the immune system attacks the body by mistake. This research helps us understand whether the investigational treatment could one day become a treatment option for people living with these conditions.

This Phase 1b clinical study focuses on understanding:

• Safety and tolerability after receiving a single dose of the investigational treatment
• How the body processes the medication (PK)
• How the medication affects the immune system (PD)Whether the body develops antibodies to the medication (immunogenicity)

Autoimmune diseases affect millions of Australians, causing daily pain, skin irritation, discomfort, reduced quality of life, and substantial healthcare costs. Many people don't get full relief from standard treatments, and in rural or underserved areas, access to specialised care can be limited.

• Globally, hundreds of millions of people live with autoimmune conditions like rheumatoid arthritis, and psoriasis.
• In Australia, arthritis alone affects about 3.7 million people, and psoriasis impacts over 600,000 individuals . 
• These conditions often persist despite standard treatments, leaving many people searching for better options.

This study aims to evaluate a new investigational therapy to help researchers understand how the immune system responds and to pave the way for future treatment advances.

You may be invited to participate if:

• You're 18 to 75 years old
• You've been diagnosed with one of these conditions: rheumatoid arthritis, psoriatic arthritis, psoriasis, or atopic dermatitis
• Your condition is moderate to severe and not fully controlled by current treatments
• You're willing to stop certain medications and stay on stable doses of allowed treatments during the study after consulting with your managing doctor
• You can attend up to 18 visits over about 35 weeks.

Participants will be reimbursed up to $1,406 for their time and inconvenience.

This trial will be conducted at our Vitality Village clinic in Birtinya.

Suitable participants will be reimbursed for their time and travel.

This trial has been reviewed and approved by an independent Human Research Ethics Committee.

What's involved?

This trial runs for about 35 weeks, including up to four weeks of screening and 18 weeks of follow-up with regular clinic visits throughout.

The investigational treatment will be administered via a subcutaneous injection on up to four occasions, each occasion being four weeks apart.

This is an open-label study, which means everyone receives the investigational treatment. There is no placebo group.

Procedures:

• Health checks (including physical exams, vital signs, and medical history updates)
• Blood and urine samples collection
• Have heart health monitored with ECGs
• Skin photography if you have psoriasis, cutaneous lupus, or atopic dermatitis
• Exploratory blood samples for genetic and biomarker research
• Completion of eDiary (a questionnaire to check your health and well-being)

Where can I find more information?

More information can be requested by contacting the recruitment team on 07 5409 8640 or trialparticipant@usc.edu.au. Do not send personal medical information to this email address. Alternatively, the team will be more than happy to answer any questions you may have when they call.