A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)
Atopic dermatitis, commonly called eczema, can cause uncomfortable, dry, red, and itchy skin that is difficult to manage with regular creams. The SIERRA1 study is looking at a new tablet called soquelitinib to find out if it can help improve moderate to severe eczema symptoms in adults. Participants will be placed into groups by chance. One group will take the new medicine, while another group will take a placebo, which is a harmless dummy pill that looks identical. Neither you nor your study doctor will know which one you receive. Over 12 weeks, doctors will check your skin to see if symptoms improve and whether your itching decreases. They will also keep a close eye on your health to make sure the treatment is safe. Taking part is completely voluntary, and you can leave the study whenever you wish.
At a glance
What is this study about?
Atopic dermatitis is the most common form of eczema. For many people, it means living with skin that is inflamed, cracked, sore, and intensely itchy. When eczema is moderate to severe, everyday moisturisers and steroid creams may not be enough to keep flare-ups under control. This can disrupt sleep, cause daily discomfort, and affect your overall quality of life.
This study, named SIERRA1, is testing a new oral medicine called soquelitinib. Instead of putting a cream on your skin, you take it as a tablet. Researchers want to see if this medicine can calm down the body's immune signals that trigger eczema flare-ups. By doing this, they hope it might clear the skin and ease itchy sensations from the inside out.
The main goal of the study is to see how much a person's eczema improves after 12 weeks of treatment compared to a placebo, which is a tablet with no active medicine. The team will also check how safe the drug is, how well the body handles it, and how much it improves daily wellbeing. Finding new treatments gives people with stubborn eczema more options for managing their condition in the future.
Key takeaways
- The trial tests an experimental tablet called soquelitinib for adults with moderate to severe eczema.
- It is a Phase 2 study comparing the medicine against a dummy tablet (placebo) over 12 weeks.
- Researchers want to see if the drug safely clears skin and relieves intense itching.
- Neither you nor the doctors will know which treatment you receive during the study.
- Taking part is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with moderate to severe atopic dermatitis. Both men and women can take part. To join, your eczema usually needs to cover a noticeable area of your body and cause symptoms that are not well controlled by standard creams or lotions.
You might not be able to take part if you have certain other medical conditions, severe infections, or if you are taking specific medications that could clash with the study drug. Women who are pregnant, planning to become pregnant, or breastfeeding are usually unable to join clinical trials of this kind for safety reasons.
A full health screening will take place before you join. The study medical team will check your skin, review your medical history, and carry out routine health checks to ensure taking part is safe for you.
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 atopic dermatitis (eczema).
- My eczema is moderate to severe and causes frequent itching or soreness.
- Standard skin creams and moisturisers are not keeping my eczema under control.
- I am able and willing to attend regular hospital or clinic appointments.
What does participation involve?
Taking part in this study involves taking a tablet once or twice a day as instructed by the clinic team. You will be placed at random into one of two groups: one receives soquelitinib and the other receives a matching placebo tablet. You will take the tablets for at least 12 weeks. During this period, you will need to attend regular clinic appointments so doctors can monitor your progress. At these visits, doctors will measure how much of your skin is affected, take blood and urine samples, and ask you to rate your itching and quality of life using simple questionnaires. The trial team will support you throughout, and you will have follow-up visits to check on your health even after you finish the tablets.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedSpain
- —UnverifiedBulgaria
Common questions
What is a placebo?
A placebo is a dummy pill that looks and tastes just like the real medicine but contains no active ingredients. It helps scientists see if changes in health are truly caused by the study drug.
Will I know if I am getting the real medicine?
No. This is a double-blind trial, meaning neither you nor your study doctor will know whether you are taking soquelitinib or the placebo until the trial ends.
How long will I take the study tablets?
The main treatment period lasts for 12 weeks, followed by safety checks to see how you are doing after stopping the medication.
Can I continue using my normal eczema creams?
The study team will give you clear instructions on which moisturisers you can use and which prescription treatments you may need to pause while taking part.
Do I have to pay to take part?
No, the study medicine and all related tests are provided free of charge, and you may be reimbursed for travel expenses to and from the clinic.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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