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Trial record 1 of 4 for:    oms721
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Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

This study is currently recruiting participants.
Verified July 2016 by Omeros Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02222545
First Posted: August 21, 2014
Last Update Posted: July 31, 2017
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.
Information provided by (Responsible Party):
Omeros Corporation
  Purpose
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).

Condition Intervention Phase
Thrombotic Microangiopathies Biological: OMS721 Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Assess the safety and tolerability of multiple-dose administration of OMS721 in subjects with TMA [ Time Frame: 4 to 24 weeks ]
    Incidence of Adverse Events, vital signs, ECG, and clinical laboratory tests

  • Evaluate the clinical activity of multiple-dose administration of OMS721 in subjects with TMA [ Time Frame: 4 to 24 weeks ]
    Clinical activity as assessed by platelet count


Secondary Outcome Measures:
  • Pharmacokinetics (PK) of multiple-dose administration of OMS721 in subjects with TMA [ Time Frame: Pre-dose and up to 204 days post-dose ]
    PK parameters including maximum concentration, time to maximum concentration, elimination half-life, area under time-concentration curve, clearance, and volume of distribution

  • Pharmacodynamics (PD) of multiple-dose administration of OMS721 in subjects with TMA [ Time Frame: Pre-dose and up to 204 days post-dose ]
    PD measure of inhibition of ex vivo lectin pathway activation

  • Immunogenicity of multiple-dose administration of OMS721 in subjects with TMA [ Time Frame: Pre-dose and up to 204 days post-dose ]
    Presence of ADA response


Estimated Enrollment: 89
Study Start Date: August 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMS721 low dose
Administration of OMS721 at a low dose
Biological: OMS721
Experimental: OMS721 medium dose
Administration of OMS721 at a medium dose
Biological: OMS721
Experimental: OMS721 high dose
Administration of OMS721 at a high dose
Biological: OMS721

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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): NCT02222545


Contacts
Contact: Soyoung Han 206-676-0819 shan@omeros.com
Contact: Danielle Barnhart 206-676-5051 dbarnhart@omeros.com

  Show 29 Study Locations
Sponsors and Collaborators
Omeros Corporation
  More Information

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT02222545     History of Changes
Other Study ID Numbers: OMS721-TMA-001
2014-001032-11 ( EudraCT Number )
First Submitted: August 18, 2014
First Posted: August 21, 2014
Last Update Posted: July 31, 2017
Last Verified: July 2016

Keywords provided by Omeros Corporation:
TMA, aHUS, HSCT-associated TMA, TTP

Additional relevant MeSH terms:
Vascular Diseases
Thrombotic Microangiopathies
Cardiovascular Diseases
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases