A Study of Stapokibatrt in Children Subjects With Atopic Dermatitis
ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-12
SponsorKeymed Biosciences Co.Ltd
About this trial
This is a multi-center, single-arm, open-label phase 3 study to evaluate the safety, efficacy, Pharmacokinetics(PK) and immunogenicity of Stapokibatrt in children with Atopic Dermatitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in the continuing study and sign the written Informed Consent Form(ICF).
Subjects who must complete the evaluation of Week 18 of the main study.
Have the ability to communicate well with the researcher and comply with the follow-up visits of the protocol.
Disqualifiers
Planned major surgical procedure during the patient's participation in this study.
Any other circumstances in which the researcher deems not suitable to participate in this study.
Trial design
Design model
Single group
Treatments tested in this trial
Stapokibatrt
Biological/VaccineStapokibatrt Subcutaneous injection
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: Stapokibatrt groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Incidence of adverse events
Time frame
up to week 44Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: