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Study of Stapokibatrt in Children Subjects With Atopic Dermatitis

ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorKeymed Biosciences Co.Ltd

About this trial

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, Pharmacokinetics(PK), PharmacoDynamics(PD) and immunogenicity of Stapokibatrt in children with moderate-to-severe atopic dermatitis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 2 and ≤ 11 years old.

Diagnosis of AD according to the American Academy of Dermatology Consensus (2014) Criteria.

With moderate-to-severe AD, and inadequate response to topical medications.

Disqualifiers

Prior treatment with Stapokibart

Treatment with dupilumab within 13 weeks prior to the baseline visit, or treatment with anti-IgE(Immunoglobulin E) monoclonal antibody，other biological agents within 5 half-lives prior to the baseline visit .

Treatment with immunosuppressants/immunomodulatory drugs, ultraviolet therapy, or systemic traditional Chinese medicine for AD within 4 weeks prior to the baseline visit.

Treatment with a topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or topical Phosphodiesterase-4(PDE-4) inhibitor within 1 weeks prior to the baseline visit.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stapokibatrt

    Biological/Vaccine

    Stapokibatrt 1 or 2 ml,Subcutaneous injection(SC)

  • Placebo

    Other intervention

    Placebo of matching volume，Subcutaneous injection(SC)

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Stapokibatrt groupExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of subjects achieving Eczema Area and Severity Index(EASI-75) at week 18

The EASI is a composite index with scores ranging from 0 to 72. Four Atopic Dermatitis(AD) disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).

Time frame
Up to week 18

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: