JPRN-jRCT2071210034
Completed
Phase 2
Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid
agabukuro Hiroshi0 sites30 target enrollmentJune 17, 2021
ConditionsMild to moderate bullous pemphigoid
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Mild to moderate bullous pemphigoid
- Sponsor
- agabukuro Hiroshi
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) All sexes, 20 years old and older
- •2\)Patients with mild to moderate bullous pemphigoid (BP) who meet the following 1 or 2
- •1 Patients satisfied with one or all items of A and both B\-1 and B\-2\- (2\) and distinguished from the diseases listed in C.
- •2 Patients satisfied with one or all items of A, two of B\-2, and distinguished from the diseases listed in C.
- •A: Clincal diagnosis
- •1\. Cutaneous tense bullae and erosions
- •2\. Cutaneous itchy erythema on the skin
- •B: Laboratory diagnosis
- •1\. Histopathology
- •(1\) Subepidermal blisters are observed
Exclusion Criteria
- •1\) Patients with clinically significant medical condition, mental condition, or medical history which the investigator judges to interfere the subject's ability to participate in the clinical trial or determines that participation in the clinical trial increases the risk of the subject.
- •2\) Patients with BP resistant to oral steroid or IVIG therapy
- •3\) Patients with suspected drug\-induced BP
- •4\) Patients with prior treatment for immunosuppressants, IVIG, plasmapheresis or steroid pulse therapy
- •5\) Patients with skin diseases that interfere with the evaluation of BP
- •6\) Patients with a history of prior treatment with prohibited drugs within the prescribed period before the start of study drug administration
- •7\) Patients who have been previously treated with biologics and have not passed more than 5 times the T1 / 2 period of the drug used at screening.
- •8\) Patients who participated in other clinical trials (excluding observational studies)
- •9\) Patients who disagree with contraception
- •10\) Pregnant or lactating female patients
Outcomes
Primary Outcomes
Not specified
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