A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
Study Identifier:
SYNT001-103
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other
Available Documents
Study Details
Medical Condition
- Skin, Hair & Nails - Other
- Pemphigus Vulgaris
- Unmapped
Study Drug
- Drug: ALXN1830
Date
Jul 2017 - Jan 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Skin, Hair & Nails - Other
- Pemphigus Vulgaris
- Unmapped
Study Drug
- Drug: ALXN1830
Date
Jul 2017 - Jan 2019
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion 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
Protocol 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).
Trial Locations
Location
Status
Location
Alexion Study Site
Chapel Hill, North Carolina, United States, 27516
Status
N/A
Location
Alexion Study Site
Durham, North Carolina, United States, 27710
Status
N/A
Location
Alexion Study Site
Philadelphia, Pennsylvania, United States, 19104
Status
N/A