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Study of Camoteskimab and Sodium Chloride Placebo in Adults with Moderate-to-Severe Atopic Dermatitis

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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 adults who have moderate-to-severe Atopic Dermatitis, a chronic skin condition that causes red, itchy, and inflamed patches. Participants will receive either the investigational medicine Camoteskimab or a matching placebo, both given as a subcutaneous injection (an injection placed just under the skin). The purpose of the study is to evaluate the effectiveness and safety of camoteskimab in this patient group.

During the trial, volunteers will receive the assigned injection at regular visits over several months. At each visit, doctors will check the skin’s condition and the level of itching using simple scales. One of the scales, called the EASI score, measures how much of the body is affected and how severe the rash is. Another assessment, the vIGA-AD, looks at overall disease activity, while the PP-NRS records how strongly the patient feels the itch each day. These checks help determine whether the medication improves the skin and reduces itching compared with the placebo.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    After you join the study, you will have a baseline visit where the research team records your health information and the severity of your atopic dermatitis.

    Based on the baseline information, you will be randomly assigned to receive either camoteskimab (the investigational medicine) or isotonische natriumchlorid‑lösung 0,9 % (placebo).

  2. Step 2

    First injection

    You will receive a subcutaneous injection (injection under the skin) of the assigned product.

    The exact dose is not specified in the study description; it will be prepared by the study staff and administered according to the trial protocol.

  3. Step 3

    Regular treatment period

    You will continue to receive subcutaneous injections of the same product for a total of 24 weeks.

    Injections will be given on the schedule determined by the study, and you will be asked to attend clinic visits throughout this period to monitor safety and collect study data.

  4. Step 4

    Follow‑up visits and assessments

    During the 24‑week treatment period you will attend follow‑up visits where the research team will check for any side effects and evaluate the condition of your skin.

    The assessments include:

    easi – a score that measures the extent and severity of eczema; the primary goal is to see the percentage change from the start of the study.

    easi‑75 – the proportion of participants who achieve at least a 75 % improvement in the easi score.

    vig­a‑ad – a physician‑rated global assessment of atopic dermatitis; the aim is to reach a score of 0 or 1 and improve by at least 2 points.

    pp‑nrs – a numeric rating scale for itch, where a reduction of 4 points or more indicates meaningful improvement.

  5. Step 5

    Week 24 final evaluation

    At week 24 you will have a final evaluation that includes the same measurements used during the study (easi, easi‑75, vig­a‑ad, pp‑nrs).

    The results will be used to determine the efficacy and safety of the medication you received.

  6. Step 6

    Study completion visit

    After the week 24 assessment, you will attend a study completion visit where any remaining safety checks are performed and you will receive information about the next steps for your care.

Who can join the trial?

7 criteria

  • Age: You must be between 18 and 65 years old when you sign the consent form.
  • Atopic Dermatitis (AD) for at least 1 year: You need a doctor‑confirmed diagnosis of chronic eczema that has lasted a year or more, using standard clinical signs (the Hanifin and Rajka criteria).
  • Moderate‑to‑severe AD: You must have an Investigator Global Assessment (IGA) score of 3 or higher (on a 0‑to‑4 scale where 3 = moderate, 4 = severe), skin involvement of at least 10% Body Surface Area (BSA), an Eczema Area and Severity Index (EASI) score of 16 or higher, and a Peak Pruritus Numerical Rating Scale (PP‑NRS) score of 4 or higher at baseline (based on at least four days of itch ratings during the seven days before the baseline visit).
  • Candidate for systemic therapy: Your eczema must not have improved enough with prescription creams or ointments used for at least 28 days (or the full time recommended), or the topical medicines must be unsafe for you because of side effects.
  • Emollient use: You must have been applying a daily moisturizer (not containing urea) for at least one week before the baseline visit and agree to keep using the same product at least once each day throughout the study. Different moisturizers can be used on different body parts if needed.
  • Contraception requirements: Women of childbearing potential who are sexually active must use a highly effective birth‑control method (such as combined hormonal pills, progesterone‑only methods, intrauterine devices, a vasectomized partner, or surgical sterilization) starting at least four weeks before the first dose and continuing until five months after the last dose, and they must have been on a stable dose of the method for at least four weeks. Reliable abstinence from vaginal sex for at least four weeks before the study and throughout the study period (including five months after the last dose) is also acceptable. Men who are sexually active and have partners who could become pregnant must also use contraception and must not donate sperm or try to conceive during treatment and for five months after the last dose.
  • Informed consent: You must sign a consent form that shows you understand the study and agree to follow all the rules and restrictions described in the protocol.

Who cannot join the trial?

38 criteria

  • Severe illness or psychiatric problems: If you have a serious medical condition or a mental health issue such as severe depression or a suicide attempt in the past 10 years, the investigator may decide you are not suitable.
  • Active infection needing systemic medication: If you have a bacterial, viral, fungal, or parasitic infection that required whole‑body (systemic) antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the first study visit, you cannot join.
  • Use of more than two prior biologics or systemic JAK inhibitors: If you have taken more than two different biologic drugs or systemic JAK‑inhibitor medicines for atopic dermatitis before, you are excluded.
  • Inadequate response to systemic JAK inhibitor: If a systemic JAK‑inhibitor medicine for atopic dermatitis did not work for you, you cannot participate.
  • Other active skin disease or infection: Having another skin condition such as psoriasis or lupus, or a skin infection (bacterial, fungal, or viral) that could affect the study’s evaluation of your eczema makes you ineligible.
  • Recent severe eczema flare: If you had a major worsening (flare) of eczema within 4 weeks before screening, the investigator may consider you unsuitable.
  • Serious additional disease: A severe other illness that might need systemic steroids (medicines that affect the whole body) or close monitoring, such as unstable chronic asthma, excludes you.
  • Abnormal heart test (ECG): Significant irregularities in a resting electrocardiogram (ECG) that could interfere with heart‑safety measurements make you ineligible.
  • Severe uncontrolled allergic disease: Severe, uncontrolled seasonal or allergic rhinitis (hay fever), severe uncontrolled asthma, or any other severe uncontrolled atopic disease exclude you.
  • Recent use of prescription‑only medicated moisturizers: Using prescription eczema moisturizers within 2 weeks before the baseline visit disqualifies you.
  • Active HIV infection: A positive test for HIV antibodies indicates active HIV infection and excludes participation.
  • Active hepatitis B infection: Positive hepatitis B surface antigen or core antibody confirmed by PCR test means active hepatitis B and you cannot join.
  • Active hepatitis C infection: Positive hepatitis C antibody confirmed by RNA test indicates active infection; however, if you have documented cure from hepatitis C, you may still be eligible.
  • Evidence of active or latent tuberculosis (TB): A positive TB test (IGRA or PPD) shows active or hidden TB and excludes you, unless a TB specialist confirms you do not have TB or you have completed proper treatment.
  • Recent live vaccine: Receiving a live or attenuated vaccine (e.g., measles, mumps, rubella, chickenpox) within 6 weeks before screening makes you ineligible.
  • Recent or planned major surgery: Having major surgery within 8 weeks before the baseline visit or planning major surgery during the study excludes you.
  • Known immune deficiency or immunocompromised state: If your immune system is weakened by a condition or medication, you cannot participate.
  • Recent cancer diagnosis: A cancer diagnosis (malignancy) within the past 5 years excludes you, except for completely removed basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
  • Previous anti‑IL‑18 therapy: Prior treatment with anti‑IL‑18 medication makes you ineligible.
  • Allergy to study drug components: If you are allergic or sensitive to any part of the investigational medication, you cannot join.
  • Recent use of dupilumab, tralokinumab, lebrikizumab, or nemolizumab: Using any of these medicines within 8 weeks before baseline excludes you.
  • Recent systemic JAK inhibitor: Use of a systemic JAK‑inhibitor within 4 weeks before baseline makes you ineligible.
  • Recent medicated topical treatments: Any prescription or over‑the‑counter skin cream or ointment that could affect eczema (including steroid creams, PDE4 inhibitors, calcineurin inhibitors, topical JAK inhibitors, tar, antibiotics, medical devices, or bleach baths) used within 2 weeks before baseline excludes you.
  • Recent systemic therapies affecting eczema: Systemic medicines such as retinoids, calcineurin inhibitors, methotrexate, hydroxyurea, azathioprine, or oral/injectable steroids taken within 4 weeks before baseline disqualify you. Inhaled or nasal steroids are allowed.
  • Recent investigational biologic drug: Participation in a trial with a biologic drug approved after this study’s protocol started, within 12 weeks (or 5 half‑lives, whichever is longer) before screening, excludes you.
  • Recent investigational non‑biologic drug or device: Use of any experimental non‑biologic medication, device, or procedure within 4 weeks (or 5 half‑lives) before screening makes you ineligible.
  • Recent UV‑B phototherapy or excimer laser: Receiving UV‑B light therapy (including tanning beds) or excimer laser treatment within 4 weeks before baseline or during the study excludes you.
  • Recent PUVA treatment: PUVA (psoralen plus UVA) therapy within 4 weeks before baseline makes you ineligible.
  • Recent sedating antihistamines: Taking sleep‑inducing antihistamines such as doxepin, hydroxyzine, or diphenhydramine within 1 week before baseline excludes you.
  • Recent topical urea products: Using skin products that contain urea within 1 week before baseline disqualifies you.
  • Recent antibiotics: Systemic antibiotics within 2 weeks or topical antibiotics within 1 week before baseline make you ineligible.
  • Recent intravenous immunoglobulin (IVIg): Receiving IVIg therapy within 12 weeks before baseline excludes you.
  • Low kidney function: A glomerular filtration rate (GFR) lower than 45 mL/min/1.73 m² indicates reduced kidney function and makes you ineligible.
  • Low hemoglobin: Hemoglobin level of 8 g/dL or less (a measure of red blood cells) excludes you.
  • Low neutrophil count: Neutrophils (a type of white blood cell) 1,500 per microliter or fewer make you ineligible.
  • Low platelet count: Platelets 100,000 per microliter or fewer exclude you.
  • Pregnancy, breastfeeding, or trying to conceive: Female participants who are pregnant, nursing, or attempting to become pregnant cannot join.
  • Unlikely to follow study procedures: If the investigator believes you are unlikely to take the medication as directed or follow the study schedule, you are excluded.
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Investigated drugs

Camoteskimab is an investigational medicine being tested to see if it can help adults who have moderate‑to‑severe atopic dermatitis, a skin condition that causes itchy, inflamed patches. In this study, participants receive Camoteskimab by a subcutaneous injection (a shot under the skin) in a liquid solution. The goal is to find out whether the drug reduces the severity of the rash, improves skin appearance, and relieves itching compared with a placebo, while also monitoring its safety for possible side effects.

What is already known about the treatment

  • Camoteskimab

    Camoteskimab is given as a subcutaneous injection using a sterile solution for infusion. It is an investigational human monoclonal antibody that is currently being studied in Phase 2b trials for moderate‑to‑severe atopic dermatitis. The drug works by blocking inflammatory signals in the immune system that cause skin rash and itching. It belongs to the class of immunomodulating monoclonal antibodies.

  • Isotonische Natriumchlorid‑Lösung 0,9 % EIFELFANGO®

    This product is a sterile 0.9 % sodium chloride solution administered by subcutaneous injection. It is an approved, widely used isotonic saline that serves as a placebo or fluid replacement in clinical settings. The solution simply provides salt and water, restoring normal fluid balance without any active drug effect. It is classified as an electrolyte solution and volume expander.

Investigated diseases

Atopic dermatitis (AD) - Atopic dermatitis is a chronic inflammatory skin condition that causes red, itchy patches. It often begins in childhood and may persist into adulthood. The rash commonly appears on the face, elbows, knees, and hands and can become thicker and more scaly with repeated scratching. Symptoms tend to flare up periodically and may spread to larger areas over time. Triggers such as allergens, stress, or changes in temperature can worsen the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525673-39-00Protocol codeAP43CP04Estimated enrolment280 patients

sourced from the EU Clinical Trials Register and site verification

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