Phase 2
N=58
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
Thrombotic Microangiopathies
Bottom Line
View on ClinicalTrials.gov: NCT02222545 ↗Enrolled (actual)
58
Serious AEs
56.9%
Results posted
Aug 2024
Primary outcome: Primary: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA — 0; 0; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OMS721 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Omeros Corporation
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA |
0; 0; 27 | — |
| PRIMARY Number of Participants With HSCT-TMA Who Respond to OMS721 |
0; 0; 17 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: 100-day Survival |
0; 0; 19 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Overall Survival |
274 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Duration of Response |
561 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion |
8 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion |
11 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count |
29.5 | — |
| SECONDARY Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 |
14.2 | — |
| SECONDARY Participants With HSCT-TMA (ADA) |
3; 0; 1; 1; 0; 6 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH |
-111.9 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine |
-0.18 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin |
67.7 | — |
| SECONDARY Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin |
0.38 | — |
| SECONDARY Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 |
14.2 | — |
| SECONDARY Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 |
14.2 | — |
| SECONDARY Participants With HSCT-TMA: Pharmacodynamics (PD) |
26.3; 95.9 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02222545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.