Imatinib treatment of autoimmune bullous diseases

Phase 1

• Conditions: Autoimmune bullous disease including pemphigus group and pemphigoid group; D012872

• Registration Number: JPRN-jRCTs051180069
• Lead Sponsor: Kabashima Kenji

Brief Summary

The standard treatment for autoimmune bullous diseases is systemic glucocorticoids. This treatment causes serious side effects such as compromised infections that can result in death. This study evaluated whether systemic imatinib could ameliorate autoimmune bullous diseases. Beneficial effect with the additive seven day-administration of imatinib on the standard glucocorticoid-based treatment was unapparent. The reason for this may be the short duration of imatinib administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-19
• Study Completion: 2021-12-31
• Results First Posted: 2023-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Eligibility (inclusion) criteria
1) Diagnosed as pemphigus group or pemphigoid group.
2) Those who are not expected to be treated with pulse steroid therapy or intravenous immunoglobulin (IVIG).
3) The age at the time of consent acquisition is 20 or over 20 years old.
4) The latest blood test and liver function test within 4 weeks before registration satisfy all of the following:
Neutrophil count >= 1,500/mm3; platelet count >= 75,000/mm3; AST (GOT) < 120 IU/L; ALT(GPT) < 120 IU/L; total bilirubin < 1.8 mg/dL.
5) Males, those agreeing to contraception for 4 weeks from the start of the test drug administration to the final administration day of the test drug. Females, those after surgical contraceptive surgery such as postmenopausal (more than one year since the last menstruation), or bilateral oophorectomy.
6) Written informed consent by the patient has been obtained.

Exclusion Criteria

Exclusion criteria
1) No history of allergy to Imatinib.
2) Those who have one of the following complications:
Serious heart disease, serious liver disorder, serious renal disorder or past history of such conditions.
3) Those who had given consent of participation in other trials within 4 weeks before the acquisition of this study.
4) Those who are judged to be unsuitable for carrying out this study by the investigator or shared medical doctors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PDAI/BPDAI

Secondary Outcome Measures

Name	Time	Method
Titers of autoantibodies in serum.<br>Titers of antibodies in other body fluids including saliva and blister contents.