RecruitingPhase IIIInterventional

Trial to investigate the benefits of two drugs, adalimumab and methotrexate, in treating patients with moderate psoriasis

Psoriasis is a common condition that causes raised, scaly, and often itchy patches on the skin. In the UK, people with moderate psoriasis are often treated with a long-standing medicine called methotrexate. Newer medicines called biologics, such as adalimumab, target the specific immune signals that cause psoriasis. Adalimumab is currently only available on the NHS for severe psoriasis because more research is needed to see if it is better for moderate cases. This clinical trial compares adalimumab directly against methotrexate in adults with moderate plaque psoriasis. Participants will receive either weekly methotrexate injections or adalimumab injections every two weeks. Both treatments are delivered to the home and self-injected after training. Over 16 weeks, doctors will monitor skin clearing, side effects, and overall quality of life. The results could help update NHS guidelines and improve treatment choices in the future.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Newcastle Clinical Trials Unit

Enrolment target

310

Start

01 Sep 2026

Estimated completion

01 Mar 2028

Psoriasis

What is this study about?

Psoriasis affects around 3 in every 100 people in the UK. It causes red, flaky, and sometimes uncomfortable patches of skin. For people living with moderate psoriasis, symptoms can have a significant effect on daily activities, comfort, and emotional wellbeing.

For many years, the standard treatment for moderate psoriasis has been methotrexate. Methotrexate works by calming the immune system, but it requires regular blood tests to check the liver and blood cells. Newer treatments called biologics, including a medicine called adalimumab, block specific immune signals with fewer expected side effects. However, adalimumab is currently only offered to people with severe psoriasis on the NHS because there is not yet enough evidence supporting its use for moderate disease.

This trial, run by the Newcastle Clinical Trials Unit, aims to find out whether adalimumab works better than methotrexate for moderate plaque psoriasis. Researchers will look for a 75% improvement in skin symptoms over 16 weeks, which is the recognised level for meaningful relief. They will also look at treatment costs and how each medicine impacts everyday life to help decide whether NHS guidelines should be updated.

Key takeaways

Compares adalimumab with methotrexate for adults with moderate plaque psoriasis.
Aims to find out if adalimumab clears skin better and improves daily quality of life.
Participants take self-injected medication at home for 16 weeks.
Medications are delivered directly to your home, and full injection training is provided.
Travel expenses for hospital visits are reimbursed, and taking part is completely voluntary.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with moderate plaque psoriasis. Participants must be willing and able to give themselves injections under the skin at home after receiving training from the healthcare team.

You cannot take part if you have used methotrexate or adalimumab in the past six months, or if you have ever used any biologic treatment before. People who have recently had light therapy (phototherapy), used strong steroid creams, or taken other systemic psoriasis drugs will also need to wait before joining.

For safety reasons, this study is not suitable for people who are pregnant, breastfeeding, or planning to have a baby (this applies to both men and women). It also excludes people with certain health conditions that affect the immune system, such as active tuberculosis, severe heart failure, multiple sclerosis, or a history of severe mental health problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with moderate plaque psoriasis.
I have not taken methotrexate or adalimumab in the last 6 months.
I have never used biologic treatments for psoriasis or joint problems.
I am comfortable learning to give myself injections at home.
I am not pregnant, breastfeeding, or planning a pregnancy.

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly assign you to one of two groups. You will receive either weekly methotrexate injections or adalimumab injections taken once every two weeks. Both medicines will be delivered to your home, and clinic nurses will show you how to inject them yourself. The main study treatment lasts for 16 weeks. During this time, you will attend hospital visits for skin checks, blood tests, and quality-of-life questionnaires. You will also have a routine chest X-ray at the start to ensure your lungs are clear. Your travel expenses for clinic visits will be reimbursed, and appointment times can be flexibly scheduled within a two-week window.

Potential risks and benefits

Taking part may significantly improve your skin symptoms and overall wellbeing, while helping researchers improve future care for people with psoriasis. As with any medication, both treatments carry potential risks, such as mild pain or redness where you inject, or an increased chance of catching everyday infections like colds. You will also need to attend clinic appointments and have blood tests and a chest X-ray, which exposes you to a very small amount of radiation similar to about 10 days of natural background radiation in the UK. Taking part is entirely voluntary, and you can withdraw from the study at any point without your standard NHS medical care being affected in any way.

Locations (1)

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Approximate
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Common questions

How is it decided which medicine I will receive?

A computer assigns you to either methotrexate or adalimumab at random, like flipping a coin. Neither you nor the trial doctor can choose your group.

Do I have to pay for the study medicines or travel?

No. The medicines and home delivery are free, and any reasonable travel costs you have when attending study visits will be reimbursed.

Will I have to inject myself?

Yes, self-injection at home is standard for these treatments. The trial nurses will provide full, step-by-step training so you feel confident doing this.

Can I take part if I want to have a baby soon?

No. Because these medications can be harmful to an unborn child, neither men nor women trying to conceive can join, and reliable contraception must be used.

What happens if my skin worsens during the study?

The clinical team will monitor you closely. If your skin flares up or you feel unwell, doctors can provide additional care or stop the study treatment if needed.

How to find out more

Philip Hampton

methormab@newcastle.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.