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A Safety Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)

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ClinicalTrials.gov Identifier: NCT03075904
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Syntimmune, Inc.

Study Description
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Brief Summary:
This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on pemphigus disease activity markers of intravenous (IV) SYNT001.

Condition or disease Intervention/treatment Phase
Pemphigus Pemphigus Vulgaris Pemphigus Foliaceus Drug: SYNT001 Phase 1

Study Design
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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, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects With Chronic 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
SYNT001 Dose 1
 Drug: SYNT001
IV in 250 mL over 1 hour administered on Day 0, 7, 14, 21, and 28
Experimental: Cohort 2
SYNT001 Dose 2
 Drug: SYNT001
IV in 250 mL over 1 hour administered on Day 0, 7, 14, 21, and 28


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of safety data (counts and percentages of adverse events) [ Time Frame: Day 0 - Day 112 ]
    counts and percentages of adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics (serum concentration of SYNT001) [ Time Frame: Day 0, 1, 2, 5, 28, 29, 30, 33 ]
    serum concentration of SYNT001

  2. Pemphigus Disease Area Index (PDAI) [ Time Frame: Day 0, 7, 14, 21, 28, 33, 42, 56, 84, 112 ]
    disease activity marker


Eligibility Criteria
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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 60 days of screening
  • Any exposure to an investigational drug or device within the 30 days prior to screening
  • Plasmapheresis or immunoadsorption within 60 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
Contacts and Locations
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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 617-947-8038 SYNT001Clinical@syntimmune.com

Locations
United States, California
Clinical and Translational Research Unit, Stanford University Recruiting
Palo Alto, California, United States, 94304
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
United States, New York
University at Buffalo, Clinical and Translational Research Center Recruiting
Buffalo, New York, United States, 14203
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27516
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Syntimmune, Inc.
More Information
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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: March 14, 2018
Last Verified: March 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