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Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Adults with Moderate to Severe Atopic Dermatitis (Phase 2 Study)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Atopic dermatitis (AD), a chronic skin condition that causes itchy, red, and inflamed patches. The investigational medication being evaluated is Soquelitinib, an oral tablet taken by mouth, and it will be compared with placebo tablets that contain no active drug. The aim of the trial is to determine whether different dosing amounts of Soquelitinib improve the signs and symptoms of AD compared with placebo.

Participants will be randomly assigned to receive either a low dose once daily, a low dose twice daily, a higher dose once daily, or placebo for about three months. Throughout the study, researchers will monitor changes in the severity of the rash using the EASI score, a measure that rates the extent and intensity of eczema. They will also assess overall skin improvement with a global rating called vIGA, track itch intensity using a numeric scale known as PP-NRS, and evaluate the impact on daily life through quality‑of‑life questionnaires such as the DLQI and POEM. Safety will be checked by recording any side effects that occur during the treatment period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment assignment

    After enrollment you will be randomly assigned to receive either soquelitinib tablets or matching placebo tablets. the possible soquelitinib regimens are 200 mg taken once daily, 200 mg taken twice daily, or 400 mg taken once daily. the tablets are identical in appearance, so you will not know which you receive.

  2. Step 2

    Baseline assessments

    Before starting the medication, a series of measurements will be taken to record the current severity of your atopic dermatitis. these include the earl skin severity index (easi) score, the percentage of body surface area affected, a patient‑reported itch score (pp‑nrs), a quality‑of‑life questionnaire (dlqi), and a symptom diary (poem). the results serve as a reference point for later comparisons.

  3. Step 3

    Initiation of study medication

    You will begin taking the assigned tablets orally each day for a total of 12 weeks. if assigned to the 400 mg once‑daily regimen, you will take one tablet each morning. if assigned to the 200 mg once‑daily regimen, you will take one tablet each morning. if assigned to the 200 mg twice‑daily regimen, you will take one tablet in the morning and one tablet in the evening. the placebo group follows the same schedule with matching tablets.

  4. Step 4

    Regular clinic visits

    Clinic visits are scheduled at week 4, week 8, and week 12 after starting the medication. during each visit, the same assessments performed at baseline (easi, affected body surface area, pp‑nrs, dlqi, poem) will be repeated to track changes. vital signs and basic laboratory tests may also be checked to monitor safety.

  5. Step 5

    Monitoring for side effects

    Throughout the 12‑week treatment period you are asked to report any new symptoms, discomfort, or health problems to the study staff. these are recorded as treatment‑emergent adverse events and are evaluated for severity and relationship to the study medication.

  6. Step 6

    End of treatment assessment

    At week 12 you will undergo a final set of assessments identical to those performed at baseline and the earlier visits. the primary goal is to determine the percent change in easi score from baseline. secondary goals include the proportion of participants achieving a 75 % reduction in easi, improvement in investigator‑global assessment, reduction in itch score, and changes in quality‑of‑life measures.

  7. Step 7

    Study completion and follow‑up

    After the final visit, the study medication is discontinued. you may be asked to attend a short follow‑up contact to record any late‑appearing side effects, but no further study medication will be taken.

Who can join the trial?

8 criteria

  • You must be an adult (at least 18 years old).
  • You must have a diagnosis of atopic dermatitis (AD) confirmed by a doctor using a standard set of signs called the Hanifin and Rajka criteria, and your symptoms must have started at least one year before the screening visit.
  • Your eczema must be moderate to severe, which means a score of 16 or higher on the Eczema Area and Severity Index (EASI), involvement of 10% or more of your body surface area (BSA), and a rating of 3 or higher on the Investigator Global Assessment (vIGA) at screening and on Day 1.
  • A second, independent doctor must review full‑body photographs taken at screening and agree that your eczema severity meets the moderate‑to‑severe criteria.
  • Your average itch rating over the seven days before randomization must be 4 or higher on the Patient‑Reported Pruritus Numerical Rating Scale (PP‑NRS), which rates itch from 0 (no itch) to 10 (worst possible itch).
  • You must have a documented history of using topical (skin creams or ointments) and/or systemic therapy (medicines taken by mouth or injection) for AD within the six months before randomization.
  • If you are male, you must agree to use contraception during the study and for at least 120 days after the last dose, and you must not donate sperm during that time.
  • If you are female, you must not be pregnant or breastfeeding, and you must either be unable to become pregnant or, if you could become pregnant (woman of childbearing potential, WOCBP), agree to use contraception during the study and for at least 120 days after the last dose.

Who cannot join the trial?

13 criteria

  • Cannot join if you have not responded to more than two strong medicines used for severe eczema (such as cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, dupilumab, tralokinumab, lebrikizumab, nemolizumab, abrocitinib, baricitinib, or upadacitinib) according to your medical history or interview.
  • Cannot join if you are currently using or have a history of other skin problems (like psoriasis, skin lupus, serious burns, or large tattoos) that would make it hard to see how the study drug affects your eczema.
  • Cannot join if you have any active skin disease or skin infection (bacterial, fungal, or viral) that needed pills or injections within the last 30 days, or that could interfere with evaluating your eczema.
  • Cannot join if you have a weak immune system, a serious past infection that spread through the body (such as sepsis, severe pneumonia, or bone infection), or any current infection outside the skin that required antibiotics or similar medicines within the last 30 days.
  • Cannot join if you have a condition that weakens your immune system not caused by medication (for example, common variable hypogammaglobulinemia), or if you have significant health problems like low blood counts (anemia, neutropenia, thrombocytopenia), poor kidney or liver function, planned surgery, or if you are permanently wheelchair‑bound, bedridden, or unable to take care of yourself.
  • Cannot join if you have an unstable or uncontrolled illness, including serious heart problems (such as unstable chest pain, uncontrolled high blood pressure, or moderate to severe heart failure), lung, stomach, hormone, blood, or nerve disorders that could affect your safety or the study results.
  • Cannot join if your kidney function is moderately or severely reduced, measured as an estimated glomerular filtration rate (eGFR) of 59 mL/minute or lower.
  • Cannot join if you have liver disease that does not meet safe limits set by the FDA (no brain confusion from liver disease, no fluid buildup in the abdomen, blood bilirubin ≤2.0 mg/dL, albumin ≥3.5 g/dL, and clotting time not more than 4 seconds longer than normal).
  • Cannot join if any of the following lab test results are abnormal:
    • Hematocrit (percentage of red blood cells) less than 30%.
    • Neutrophil count (a type of white blood cell) less than 2,000 per microliter.
    • Liver enzymes (ALT, AST, ALP, GGT) at least twice the normal upper limit.
    • Platelet count (cells that help blood clot) less than 100,000 per microliter.
    • Cannot join if you are currently misusing alcohol or drugs (active substance abuse).
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Investigated drugs

Soquelitinib is an experimental oral tablet being studied as a possible treatment for moderate to severe atopic dermatitis, a skin condition that causes itchy, inflamed patches. In this trial, participants take the medication by mouth, and researchers are looking at how well it reduces the severity of the eczema, how safe it is, and whether it is tolerated by patients. The study compares different ways of giving the drug to see which schedule might work best, and the results will help determine if Soquelitinib could become a new option for managing this chronic skin disease.

What is already known about the treatment

  • Placebo tablets

    These are oral tablets taken by mouth that contain no active drug, serving only as an inactive control in the study. They are used to compare the effects of the test medication and have no therapeutic purpose. As a non‑medicine, they are not approved for any medical condition and have no mechanism of action. Their classification is simply an inert control substance.

  • Soquelitinib

    Soquelitinib is an oral tablet taken by mouth, typically at a dose of 400 mg once daily in this trial. It is an investigational drug currently in Phase 2 studies and is not yet approved for general medical use. The medication is being tested for moderate to severe atopic dermatitis, a skin condition that causes itching and inflammation. It works by blocking a specific protein that helps drive skin inflammation, and it is classified as a small‑molecule targeted therapy.

Investigated diseases

Atopic dermatitis - Atopic dermatitis is a chronic inflammatory skin condition that causes itchy, red, and dry patches. It often begins in childhood but can continue into adulthood. The rash typically appears on the face, elbows, knees, and hands, and may spread to larger areas over time. Flare‑ups can be triggered by allergens, stress, or changes in temperature. The skin may become thickened and leathery with repeated scratching. Symptoms tend to wax and wane, with periods of worsening followed by calmer phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524384-20-00Protocol codeCPI-818-006Estimated enrolment202 patients

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