Trial record 1 of 1 for:    SYNT001 pemphigus
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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. Identifier: NCT03075904
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : August 23, 2018
Information provided by (Responsible Party):
Syntimmune, Inc.

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 :
  1. 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 :
  1. Pharmacokinetics (serum concentration of SYNT001) [ Time Frame: Day 0 - Day 33 or Day 0 - Day 91 ]
    serum concentration of SYNT001

  2. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT03075904

Contact: Syntimmune, Inc 1-617-206-4220

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. 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:
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases