A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

• Status: Terminated
• Trial end date: 2019-01-16
• Target enrollment: 0
• Participant gender: All

Summary

This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexion Pharmaceuticals; Syntimmune, Inc.

Criteria

Inclusion Criteria:

Participants must have meet the following criteria to be included:

• Were willing and able to read, understand and sign an informed consent form

• Documented diagnosis of pemphigus vulgaris or foliaceus

• Were required to use medically acceptable contraception

Exclusion Criteria:

Participants meeting any of the following criteria were excluded:

• Were unable or unwilling to comply with the protocol

• Active non-hematologic malignancy or history of non-hematologic malignancy in the 3 years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in situ)

• Positive for human immunodeficiency virus (HIV) or hepatitis C antibody

• Positive for hepatitis B surface antigen

• IV immunoglobulin treatment within 30 days of screening

• Any exposure to an investigational drug or device within the 30 days prior to screening

• Plasmapheresis or immunoadsorption within 30 days of screening

• Participant had any current medical condition that, in the opinion of the Investigator, may have compromised their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results