Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:August 2014
End Date:December 2019
Contact:Soyoung Han
Email:shan@omeros.com
Phone:206-676-0819

Use our guide to learn which trials are right for you!

A Phase 2, Uncontrolled, Three-Stage, Dose-Escalation Cohort Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Clinical Activity of OMS721 in Adults With Thrombotic Microangiopathies

The purpose of this study is to assess the safety, tolerability, and clinical activity of
OMS721 in subjects with thrombotic microangiopathies (TMA), which include atypical hemolytic
uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell
transplant -associated TMA (HSCT-associated TMA). The study will also evaluate clinical
activity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody response
(ADA).

This is a Phase 2, uncontrolled, three-stage, dose-escalation cohort study in subjects with
three forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia
(TTP), and hematopoietic stem cell transplant -associated TMA (HSCT-associated TMA). In the
first stage, OMS721 will be administered to escalating dose cohorts of three subjects per
cohort to identify the optimal dosing regimen. In the second stage, the dose selected in the
first stage will be administered to expanded cohorts of 40 subjects per cohort with distinct
etiologies (aHUS alone in one cohort and TTP or HSCT-TMA in the other cohort). Subjects
completing the second stage may be eligible for continued treatment in the third stage if the
investigator believes the subject is at risk for relapse of TMA, the subject tolerated OMS721
treatment, and the subject has no conditions that increase the risk of OMS721 treatment.

Inclusion Criteria:

1. Are at least age 18 at screening (Visit 1)

2. Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP

3. No clinically apparent alternative explanation for thrombocytopenia and anemia

Exclusion Criteria:

1. Had eculizumab therapy within three months prior to screening

2. Have STEC-HUS

3. Have a positive direct Coombs test

4. Have an active systemic bacterial or fungal infection requiring antimicrobial therapy
(prophylactic antimicrobial therapy administered as standard of care is allowed)
We found this trial at
10
sites
?
mi
from
Brussels,
Click here to add this to my saved trials
Cleveland, Ohio 44195
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Duarte, California
?
mi
from
Duarte, CA
Click here to add this to my saved trials
Durham, North Carolina
?
mi
from
Durham, NC
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
New York, New York 10065
?
mi
from
New York, NY
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials