A Phase 3 interventional study of Stapokibart injection and Placebo in Bullous Pemphigoid (BP), sponsored by Chengdu Kangnuoxing Biopharma,Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-10-07.
Sponsored by Chengdu Kangnuoxing Biopharma,Inc. · Phase 3, Interventional, and Treatment
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Stapokibart in subjects with Moderate to Severe Bullous Pemphigoid.
64 studies on the registry are indexed under Pemphigoid, Bullous; 8 are open to participants now.
This study's planned enrollment of 200 is above the median of 30 across 39 interventional studies indexed under Pemphigoid, Bullous.
Browse Pemphigoid, Bullous studies →Chengdu Kangnuoxing Biopharma,Inc. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Stapokibart injection
Drug: Placebo
subcutaneous injection
subcutaneous injection
Percentage of subjects achieving sustained complete remission (CR) at W36
Sustained complete remission (CR) defined as discontinuation of oral corticosteroid (OCS) therapy and achievement of CR on or before Week 16, no relapse during the period from OCS discontinuation up to Week 36, and no requirement for rescue therapy up to Week 36.
Time frame: Up to 36 weeks
Start is estimated for Nov 2025; primary completion for Mar 2028, 28 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Stapokibart
Chengdu Kangnuoxing Biopharma,Inc.