NCT02222545

Brief Summary

The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_2

Geographic Reach
12 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

January 1, 2024

Enrollment Period

5.2 years

First QC Date

August 18, 2014

Results QC Date

August 4, 2023

Last Update Submit

August 22, 2024

Conditions

Thrombotic Microangiopathies

Keywords

TMA, aHUS, HSCT-associated TMA, TTP

Outcome Measures

Primary Outcomes (2)

  • Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA

    Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs.

    Day 1 to 37 days after end of treatment, approximately up to 31 weeks.

  • Number of Participants With HSCT-TMA Who Respond to OMS721

    Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status

    Day 1 to up to 2 years following the first dose of OMS721

Secondary Outcomes (15)

  • Participants With HSCT-TMA Treated With OMS721: 100-day Survival

    Study Day of HSCT-TMA diagnosis to 100 days later

  • Participants With HSCT-TMA Treated With OMS721: Overall Survival

    Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721

  • Participants With HSCT-TMA Treated With OMS721: Duration of Response

    Study Day 1 to up to 2 years following first dose of OMS721

  • Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion

    Study Day -14 to 4 weeks following the last platelet transfusion

  • Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion

    Study Day -14 to 4 weeks following the last RBC transfusion

  • +10 more secondary outcomes

Study Arms (3)

OMS721 low dose

EXPERIMENTAL

Administration of OMS721 at a low dose

Biological: OMS721

OMS721 medium dose

EXPERIMENTAL

Administration of OMS721 at a medium dose

Biological: OMS721

OMS721 high dose

EXPERIMENTAL

Administration of OMS721 at a high dose

Biological: OMS721

Interventions

OMS721BIOLOGICAL
OMS721 high doseOMS721 low doseOMS721 medium dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are at least age 18 at screening (Visit 1)
  • Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP
  • No clinically apparent alternative explanation for thrombocytopenia and anemia

You may not qualify if:

  • Had eculizumab therapy within three months prior to screening
  • Have STEC-HUS
  • Have a positive direct Coombs test
  • Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Omeros Investigational Site

Duarte, California, 91010, United States

Location

Omeros Investigational Site

Rochester, Minnesota, 55905, United States

Location

Omeros Investigational Site

New York, New York, 10065, United States

Location

Omeros Investigational Site

Durham, North Carolina, 27710, United States

Location

Omeros Investigational Site

Madison, Wisconsin, 53792, United States

Location

Omeros Investigational Site

Brussels, Belgium

Location

Omeros Investigational Site

Leuven, Belgium

Location

Omeros Investigational Site

Liège, Belgium

Location

Omeros Investigational Site

Sofia, Bulgaria

Location

Omeros Investigational Site

Shatin, Hong Kong

Location

Omeros Investigational Site

Bergamo, Italy

Location

Omeros Investigational Site

Vilnius, Lithuania

Location

Omeros Investigational Site

Selangan, Malaysia

Location

Omeros Investigational Site

Christchurch, New Zealand

Location

Omeros Investigational Site

Katowice, Poland

Location

Omeros Investigational Site

Krakow, Poland

Location

Omeros Investigational Site

Lodz, Poland

Location

Omeros Investigational Site

Warsaw, Poland

Location

Omeros Investigational Site

Singapore, Singapore

Location

Omeros Investigational Site

Taichung, Taiwan

Location

Omeros Investigational Site

Taipei, Taiwan

Location

Omeros Investigational Site

Ban Pathumwan, Thailand

Location

Omeros Investigational Site

Bangkok, Thailand

Location

Omeros Investigational Site

Pathum Thani, Thailand

Location

Related Publications (2)

  • Khaled SK, Claes K, Goh YT, Kwong YL, Leung N, Mendrek W, Nakamura R, Sathar J, Ng E, Nangia N, Whitaker S, Rambaldi A; OMS721-TMA-001 Study Group Members. Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2 Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell Transplantation-Associated Thrombotic Microangiopathy. J Clin Oncol. 2022 Aug 1;40(22):2447-2457. doi: 10.1200/JCO.21.02389. Epub 2022 Apr 19.

    PMID: 35439028DERIVED

  • Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.

    PMID: 33783815DERIVED

MeSH Terms

Conditions

Thrombotic MicroangiopathiesAtypical Hemolytic Uremic Syndrome

Interventions

narsoplimab

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaHemolytic-Uremic SyndromeUremiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAnemia, HemolyticAnemia

Results Point of Contact

Title
Clinical Trial Manager
Organization
Omeros Corporation
ctinfo@omeros.com
(206) 676-5000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 21, 2014

Study Start

November 2, 2014

Primary Completion

January 30, 2020

Study Completion

August 11, 2020

Last Updated

August 28, 2024

Results First Posted

August 28, 2024

Record last verified: 2024-01

Locations

HK(1)SG(1)NZ(1)LI(1)BU(1)TW(2)US(5)BE(3)TH(3)MY(1)PL(4)IT(1)