bullous pemphigoid
Conditions
Interventions
Patients with steroid treatment-resistant bullous pemphigoid will be randomized at enrollment to Group A-1, Group A-2, Group B-1 or Group B-2 in a 1:1:1 ratio. This study consists of the first period
Sponsors
Takahashi Hayato
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with a confirmed diagnosis of bullous pemphigoid treated with PSL and his/her BPDAI (skin: blister/erosion) score increased again until PSL was reduced to 10 mg/day. [BPDAI (skin: blister/erosion) score of 1 at the time of obtaining consent] 2) Patients with 3 or more new lesions (bullae, eczematous lesions, urticaria-like erythema) or new lesions larger than 10 cm (eczematous lesions, urticaria-like erythema) per month that do not resolve spontaneously within 1 week, or enlargement of existing lesions or enhancement of daily itching, from 3 months prior to obtaining consent to the time of consent 3) Patients with anti-BP180NC16a IgG antibodies higher than the reference level 4) Patients treated with PSL 15-30 mg/day at the time of consent and no need for PSL dose change during the screening period 5) Patients who have been fully informed about the study and who have given their written consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Patients with a BPDAI (skin: blister/erosion) score increase of at least 14 points at two time points at least 7 days apart during the screening period 2) Pregnant or lactating women, women who may be pregnant, women of childbearing potential who do not wish to use a highly effective contraceptive method during the study period and for 6 months after completion of the study, or men who are partners of women of childbearing potential who do not wish to use a highly effective contraceptive method during the study period and for 6 months after completion of the study 3) Patients with a history of hypersensitivity or shock to humanized or murine antibodies or murine-derived components 4) Patients with serious and uncontrollable organ damage 5) Patients with diseases other than pemphigoid requiring systemic administration of steroids (e.g., asthma, Crohn's disease) within 12 weeks prior to the start of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving maintenance of remission at 24 weeks of the previous period | — |
Contacts
Public ContactYasuko Saito
Keio University School of Medicine
Outcome results
None listed