Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD



Status:Terminated
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 70
Updated:5/11/2018
Start Date:September 29, 2016
End Date:March 3, 2017

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A Phase 2, Open-label, Single-arm, Intra-subject Dose-escalation Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Moderate or Severe Chronic GVHD Inadequately Responding to First or Second Line Therapy

Chronic graft versus host diseasre (GVHD) is a serious reaction that might occur in a person
(the host) who has received cells or organs (graft) from another person because the graft
attacks the host's cells. Currently there are no approved therapies for chronic GVHD in the
USA, and patients with chroninc GVHD are treated with immunosuppressant drugs. T-lymphocytes
(a type of white blood cells) are likely to play a role in the development of chronic GVHD.
Due to the capacity of ponesimod to block the traffic of T-lymphocytes, ponesimod may be a
new therapeutic approach to treat chroninc GVHD.

The main objective of this study is to assess the effectiveness and safety of several doses
of ponesimod in subjects with chronic GVHD who did not respond to standard available
treatments.


Inclusion Criteria:

- Signed informed consent

- Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic
immunosuppressant (IS) therapy

- Women of child bearing potential must have a negative pregnancy test and use reliable
methods of contraception

Exclusion Criteria:

- Clinically significant medical conditions including active or uncontrolled infections,
new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and
uncontrolled diabetes.

- Karnofsky Performance Score < 60.

- Immunosuppressant therapies other than allowed background therapy

- Anti-arrhythmic and heart rate lowering drugs.

- Any other circumstances or conditions, which, in the opinion of the investigator, may
affect full participation in the study or compliance with the protocol
We found this trial at
10
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Bethesda, Maryland
Phone: 301-402-4899
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303 East Superior Street
Chicago, Illinois 60611
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Indianapolis, Indiana 46202
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La Jolla, California 92093
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Los Angeles, California 90095
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4921 Parkview Place
Saint Louis, Missouri 63110
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Scottsdale, Arizona 85258
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Seattle, Washington 98109
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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