A Long-term Safety and Efficacy Study Evaluating CM512 in Atopic Dermatitis.
ConditionAtopic Dermatitis (AD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeymed Biosciences Co.Ltd
About this trial
This is an Open-label ,Multicenter Study to evaluate Long-Term Safety and Efficacy of CM512 in patients with Atopic Dermatitis who have completed treatment in parent CM512 Study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
Subjects who have completed the week 18 evaluation in the parent study CM512-101102 or the End of Study(EOS) visit in the parent study CM512-100001.
Disqualifiers
Not enough washing-out period for previous therapy.
Any other condition assessed by the investigator that makes participants unsuitable for participation in this study.
Trial design
Design model
Parallel
Treatments tested in this trial
CM512
Biological/VaccineCM512 subcutaneous injection
Treatment groups
246 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
The incidence of adverse events
Time frame
up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov