A Clinical Study of B007 in the Treatment of Pemphigus.
ConditionPemphigus
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd
About this trial
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with pemphigus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who voluntarily participate in this study and sign informed consent form;
Subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases;
Subjects with first diagnosis or relapse;
Subjects who have the ability to follow the study protocol as determined by the investigator.
Disqualifiers
Subjects diagnosed with prescribed diseases;
Since the diagnosis of pemphigus, Disease duration>4 years;
Subjects using prescribed drugs;
Presence of a specified disease or history of disease;
Trial design
Design model
Single group
Treatments tested in this trial
B007
DrugB007：high dose/low dose: Subcutaneous injection was administered on days 1 and 15
Treatment groups
132 Participants
are divided into 1 treatment groupGroup A: B007Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects：Complete remission with minimal treatment
Time frame
Approximately36 weeksSecondary outcomes
1
The number of relapses of the disease
Time frame
Approximately 1 years2
Proportion of subjects：Partial remission
Time frame
Approximately 36weeks3
Change: PDAI（Pemphigus disease area index）
Time frame
Approximately 36 weeks4
CR/PR Proportion of subjects：Complete remission /Partial remission
Time frame
Approximately 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Jiaolian Drug Research and Development Co., Ltd
Lead sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Collaborator
Source ClinicalTrials.gov