Phase 2 Eczema Trial, Recruiting NCT06765005 Sponsor: Shanghai Mabgeek Biotech.Co.Ltd Condition: Eczema
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Phase 2 Eczema Trial, Recruiting

NCT06765005
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 12 to under 18 years old, of any gender, who weigh at least 30 kg (about 66 pounds)
  • People who have been diagnosed with atopic dermatitis (AD) that meets a recognised set of medical standards, and who have had AD or eczema for at least 6 months before the screening visit
  • People whose skin condition scores are at a certain level of severity — specifically, scores on three standard skin assessments (EASI, IGA, and body surface area affected) must meet minimum thresholds at both the screening and baseline visits (confirm exact score thresholds with trial site)
  • People whose AD was found to be not well controlled by topical (applied to skin) treatments within the 6 months before screening, or for whom topical treatments are medically unsuitable due to significant side effects, safety risks, allergic reactions, skin thinning, or other treatment reactions
  • People who are able to become pregnant or father a child must agree to use effective contraception throughout the study and for 6 months after the last dose
  • The participant and/or their parent or legal guardian must be willing to sign a consent form and be able to communicate with the study team and attend follow-up visits as required

Who may not be able to join:

  • People who have had a severe allergic reaction to the study drug or similar medications, or who cannot receive injections under the skin (for example, due to blood-thinning medication use, known bleeding disorders, or a condition affecting blood platelets)
  • People who have another active skin condition, such as psoriasis or lupus affecting the skin, that could interfere with assessing the eczema
  • People who have a disease that may require ongoing treatment with steroid tablets or immune-suppressing medications
  • People with certain eye conditions that the study doctor considers unsuitable for participation, such as a history of a serious inflammatory eye condition involving the cornea
  • People who have used certain medications within a set period before joining the study, including targeted inhibitors (such as JAK inhibitors), steroid tablets, cyclosporine, other immune-suppressing drugs, PDE4 inhibitors, UV light therapy, systemic herbal treatments for AD, or biologic medicines
  • People who have used allergen immunotherapy (allergy desensitisation treatment) in the 6 months before joining the study
  • People who have not stopped all topical skin treatments for at least 2 weeks before joining the study
  • People who have recently taken part in another clinical trial involving a biologic medicine or a non-biologic medicine within certain timeframes before the study, or who plan to join another drug trial during this study
  • People who have previously taken part in a clinical study of this specific product, or who have used a medication that works on a specific immune receptor (IL-4Rα) and, in the study doctor's judgement, developed resistance to it or had serious side effects from it
  • People who have received a live or live-attenuated vaccine within 3 months before screening, or who plan to receive one during the study
  • People who have had a chronic ongoing infection or a recent serious infection requiring oral or intravenous antibiotics, antiviral, or antifungal treatment within 4 weeks before joining
  • People with signs of active tuberculosis or a past history of tuberculosis that was not properly treated
  • People who have had a parasitic infection in the 6 months before screening
  • People with a history of cancer (malignant tumours)
  • People with other serious health conditions — such as heart, metabolic, or neurological diseases — that the study doctor considers unsuitable for immune-suppressing treatment
  • People with a history of alcohol or drug misuse in the 6 months before screening
  • People who, in the study doctor's opinion, have any other reason that makes participation in the study unsuitable

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: liming wu, First People's Hospital of Hangzhou

Phone: 02151371305

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
Registry
ClinicalTrials.gov
Start date
19 July 2024
Est. completion
1 May 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Incidence and severity of adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov