June. 17, 2021 |
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April. 02, 2023 |
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jRCT2071210034 |
Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid |
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Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid |
Nagabukuro Hiroshi |
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ARTham Therapeutics, Inc |
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24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa |
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+81-45-225-8858 |
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art-648@arthamther.com |
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Tanaka Akira |
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ARTham Therapeutics, Inc |
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24-8, Yamashita-cho, Naka-ku, Yokohama Kanagawa |
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+81-45-225-8858 |
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art-648@arthamther.com |
Complete |
Aug. 01, 2021 |
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Oct. 12, 2021 | ||
30 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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1) All sexes, 20 years old and older |
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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. |
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20age old over | ||
No limit | ||
Both |
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Mild to moderate bullous pemphigoid |
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Patients will be orally taking ART-648 2 mg in the evening of Day 1, 2 mg twice daily on Day 2 and 3, and 4 mg twice daily from Day 4 or later. |
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Proportion of patients achieving the cessation of new lesion formation (erosion/blister or wheal/erythema) without rescue therapy at week 4. |
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Efficacy |
ARTham Therapeutics, Inc |
Oita Univercity Hospital Institutional Review Board | |
1-1, Idaigaoka, Hasama-machi, Yufu-City, Oita | |
+81-97-586-6163 |
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gcrcjimu@oita-u.ac.jp | |
Approval | |
No |
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none |