A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03075904 |
|
Recruitment Status :
Recruiting
First Posted : March 9, 2017
Last Update Posted : August 23, 2018
|
Sponsor:
Syntimmune, Inc.
Information provided by (Responsible Party):
Syntimmune, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
This is a multicenter, open-label safety study to determine the dose regimen of SYNT001 administered intravenously in subjects with pemphigus (vulgaris or foliaceus).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pemphigus Pemphigus Vulgaris Pemphigus Foliaceus | Drug: SYNT001 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 16 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b/2, Multicenter, Open-Label, Safety, and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus) |
| Actual Study Start Date : | August 1, 2017 |
| Estimated Primary Completion Date : | November 2018 |
| Estimated Study Completion Date : | November 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pemphigus
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cohort 1
SYNT001 Dose 1
|
Drug: SYNT001
5 or 14 weekly IV infusions |
|
Experimental: Cohort 2
SYNT001 Dose 2
|
Drug: SYNT001
5 or 14 weekly IV infusions |
|
Experimental: Cohort 3
SYNT001 Dose 3
|
Drug: SYNT001
5 or 14 weekly IV infusions |
Primary Outcome Measures :
- Assessment of safety data (counts and percentages of adverse events) [ Time Frame: Day 0 - Day 112 or Day 0 - Day 175 ]counts and percentages of adverse events
Secondary Outcome Measures :
- Pharmacokinetics (serum concentration of SYNT001) [ Time Frame: Day 0 - Day 33 or Day 0 - Day 91 ]serum concentration of SYNT001
- Pemphigus Disease Area Index (PDAI) [ Time Frame: Screening to Day 112 or Screening to Day 175 ]disease activity marker
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects must meet the following criteria to be included:
- Willing and able to read, understand and sign an informed consent form
- Documented diagnosis of pemphigus vulgaris or foliaceus
- Must use medically acceptable contraception
Exclusion Criteria:
Subjects meeting any of the following criteria are to be excluded:
- Subject 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 HIV or hepatitis C antibody
- Positive for hepatitis B surface antigen
- IVIG use 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
- Subject has any current medical condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075904
Contacts
| Contact: Syntimmune, Inc | 1-617-206-4220 | SYNT001Clinical@syntimmune.com |
Locations
| United States, California | |
| Syntimmune Study Site | Recruiting |
| Palo Alto, California, United States, 94304 | |
| United States, Georgia | |
| Syntimmune Study Site | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, New York | |
| Syntimmune Study Site | Recruiting |
| Buffalo, New York, United States, 14203 | |
| United States, North Carolina | |
| Syntimmune Study Site | Recruiting |
| Chapel Hill, North Carolina, United States, 27516 | |
| Syntimmune Study Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Syntimmune Study Site | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Syntimmune Study Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Syntimmune, Inc.
| Responsible Party: | Syntimmune, Inc. |
| ClinicalTrials.gov Identifier: | NCT03075904 History of Changes |
| Other Study ID Numbers: |
SYNT001-103 |
| First Posted: | March 9, 2017 Key Record Dates |
| Last Update Posted: | August 23, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Pemphigus Skin Diseases, Vesiculobullous Skin Diseases Autoimmune Diseases Immune System Diseases |