Peridot Plaque Psoriasis Study

Plaque psoriasis is the most common type of psoriasis. It is a chronic autoimmune disease that causes raised, scaly, patches of skin. During a flare, it can often be painful and itchy especially when plaques are thickened and cracked. Treatment for plaque psoriasis often includes the use of emollients, steroids, corticosteroids, light therapy and immunosuppressants.

About the investigational product

In people with Plaque Psoriasis, their immune cells can become triggered, resulting in chronic inflammation and uncontrolled skin cell growth.

The study drug is a chemical synthetic (a drug made up from smaller molecules called amino acids). In New Zealand, there are currently some biologic treatments already available for plaque psoriasis. These existing treatments are given by injection or directly into the bloodstream. More research is needed to help develop this area of therapy for well-tolerated oral treatments.

The study drug targets a receptor protein that is embedded on the outer membrane of immune system cells. By inhibiting the receptor protein, the uncontrolled triggering of our own immune cells can be reduced.

Treatment of psoriasis has traditionally focused on suppressing the immune system and preventing the growth of skin cells. However, these current treatments can have many side effects. Current research involving cell signalling and communication supports the specific targeting the immune cells involved in the disease, providing potential new treatment options for people impacted by psoriasis. 

Study Aim

The main purpose of this study is to help investigate a potential new  product that could help people with a skin condition called plaque psoriasis.

In the first part of this study, the investigational product is taken by healthy volunteers to investigate the safety and tolerability of the study drug. We would also like to assess how the body processes the investigational product at different dose levels.  

In the second part of the study, the investigational product is taken by people with plaque psoriasis. In this part of the study, the effectiveness of the study drug in controlling Psoriasis symptoms is evaluated.

We are currently enrolling for people with Plaque Psoriasis only.

Reason to participate

This research represents an important first step in developing a potential new treatment option for people with moderate to severe plaque psoriasis. Your participation helps advance medical science and could contribute to future treatment options.

Who Can Participate

You may be eligible if you are:

• Age 18-65 years
• Patients with moderate to severe plaque psoriasis
• Weigh ≤ 110 kg
• Able to comply with study requirements

What to Expect

Study Duration: 10 weeks including…

• Screening period: Up to 28 days before dosing.
• Treatment period: Up to 29 days of oral dosing.
• Follow-up period: 42 days post-treatment.

Participants will have multiple scheduled visits, including:

• Screening visit(s) before the study begins.
• Baseline visit before the first dose.
• Regular on-site visits during the treatment period (e.g., weekly or biweekly).
• Follow-up visits at specific intervals post-treatment to monitor safety and outcomes.
• Study Procedures Include:

Screening Phase:

• Medical history review and assessment of inclusion/exclusion criteria.
• Physical examination, laboratory tests, and imaging (e.g., chest X-rays or ultrasounds).
• Consent process with detailed information on the study protocol.

Treatment Period:

• Participants will self-administer the investigational product or placebo orally for up to 29 consecutive days.
• Regular on-site monitoring, including:
• Blood sampling and efficacy evaluations of the area of your body affected by psoriasis
• Routine safety assessments, including vital signs and health checks

Follow-Up Phase:

• Continued health monitoring through scheduled visits at days 36, 43, 50, 57, 64, and 71 post-treatments or at days 35, 42, 49, 56,63 and 70 depending on the cohort.
• Blood sampling and efficacy evaluations will continue during follow-up
• Participants will be closely supported by the research team, ensuring a comfortable and informed experience throughout the study.

About the study:

Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you.  If you wish to take part and you are eligible, we would like to see you for approximately 17 clinic visits over a period of around 10 weeks.

 
Key activities at these visits include:

• Physical examinations
• Vital signs
• ECG monitoring
• X-rays and ultrasounds
• Blood samples
• Safety monitoring

Visit Duration:

•  Screening and baseline visits typically last 3–5 hours due to comprehensive evaluations.

• Visits during the treatment period (e.g., weekly visits for Cohorts 1–4) vary but may last 2–4 hours, depending on blood sampling schedules and other procedures.

• For dosing visits (e.g., Day 1 or Day 29), participants may stay for 6–8 hours for pre-dose evaluations, dosing, and post-dose monitoring.

• Follow-up visits range from 1–2 hours depending on the required tests and evaluations.

If eligible, you would take the investigational product or a placebo (looks like the investigational product but contains no active product).

The investigational product/placebo is taken as an oral tablet. The study aims to investigate how safe and well tolerated the investigational product is. This is determined by careful checks and monitoring of your health. For a product to be approved for use, it must be proven to be safe and well tolerated. This means any side effects must be acceptable and may not outweigh the potential benefits of the investigational product.

The study also investigates how well the investigational product treats symptoms of plaque psoriasis.