TS23 for Pulmonary Embolism
(NAIL-IT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TS23 for pulmonary embolism, a condition where blood clots block blood vessels in the lungs. The study compares different doses of TS23 alongside standard blood thinners to assess effectiveness and safety. Participants must have a pulmonary embolism confirmed by a special scan and remain stable, with no severe drops in blood pressure. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those who have been on certain anticoagulants like heparin for 48 hours before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that TS23 is under investigation for its ability to safely dissolve blood clots in the lungs. Earlier findings suggest that TS23 might outperform current treatments in breaking down these clots. Although specific safety data from past studies is unavailable, TS23 is now in a Phase 2 trial. This phase typically evaluates the treatment's effectiveness and safety for people. Reaching this stage generally indicates that early tests have shown potential safety for humans. Researchers are testing different doses of TS23, each combined with standard blood-thinning medication, to identify the safest and most effective dose.12345
Why are researchers excited about this trial's treatments?
Most treatments for pulmonary embolism, like heparin or warfarin, work by thinning the blood to prevent clots. But TS23 is different because it potentially targets clot breakdown directly, which might offer faster relief from symptoms. Researchers are excited about TS23 because it comes in varying doses, allowing for tailored treatment approaches that might optimize safety and effectiveness. This could mean quicker recovery times and fewer side effects compared to current anticoagulant therapies.
What evidence suggests that this trial's treatments could be effective for pulmonary embolism?
Research has shown that TS23 could be a promising treatment for pulmonary embolism, a condition where a blood clot blocks blood flow in the lungs. Early studies found that TS23 might significantly reduce stress on the heart and improve blood flow in the lungs, similar to the effects of alteplase, a drug already known to help with these issues. In tests with mice, clots broke down faster when treated with a drug similar to TS23. These findings suggest that TS23 could effectively treat pulmonary embolism by helping dissolve clots.12567
Who Is on the Research Team?
Guy L Reed, MD
Principal Investigator
Translational Sciences
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a recent pulmonary embolism (PE) confirmed by scan, showing specific heart dysfunction but stable blood pressure. It's not for those at high bleeding risk, with certain liver conditions, low blood counts, or severe kidney issues. Pregnant or breastfeeding women and those not using effective birth control are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ascending doses of TS23 or placebo with standard of care anticoagulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TS23
Trial Overview
The NAIL-IT Trial is testing TS23 against a placebo in phase II to see if it can safely dissolve blood clots in the lungs. Participants will be randomly assigned to either the drug or placebo group.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
TS23 low dose + SOC anticoagulation
TS23 medium dose + SOC anticoagulation
TS23 highest dose + SOC anticoagulation
Placebo + standard of care (SOC) anticoagulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Translational Sciences, Inc.
Lead Sponsor
Citations
Novel α2-Antiplasmin Inactivation for Lysis of Intravascular ...
On the basis of pre-clinical data, we project that by comparison to current therapy, treatment with TS23 could significantly reduce right heart failure, improve ...
Study Details | NCT05408546 | Novel α2-Antiplasmin ...
Evaluation of safety and thrombolytic effect of ascending doses of TS23 in subjects with intermediate-risk (sub-massive) acute pulmonary embolism (PE).
TS23 for Pulmonary Embolism (NAIL-IT Trial)
The research on alteplase, a drug similar to TS23, shows that it can quickly improve heart function and blood flow in the lungs for patients with pulmonary ...
Overview of an Emerging Therapeutic Approach
The ongoing phase II trials of monoclonal antibody TS23 in patients with submassive pulmonary embolism are supported by preclinical validation ...
Unique Effects of Plasminogen Activation and α2 ...
Thrombus dissolution was markedly accelerated in mice with normal α2-antiplasmin levels treated with an α2-antiplasmin-inactivating antibody (p<0.0001).
Novel α2-Antiplasmin Inactivation for Lysis of Intravascular ...
Overview. Phase II trial of TS23. Description. Evaluation of safety and thrombolytic effect of ascending doses of TS23 in subjects with ...
Inactivation of α2-Antiplasmin Dissolves Pulmonary Emboli ...
Clinical dose tPA therapy was associated with a significant increase in bleeding (p<0.01). Though more potent than tPA in dissolving pulmonary ...
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