Please sign in to follow a disease.
New antibody aims to dissolve lung clots with less bleeding risk
NCT ID NCT05408546
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a new drug called TS23, a monoclonal antibody designed to help break down blood clots in the lungs. It is for people with intermediate-risk pulmonary embolism, a serious condition where clots block blood flow. The trial compares different doses of TS23 against a placebo to see if it safely dissolves clots and improves heart function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TS23 (a monoclonal antibody that targets a protein involved in blood clot breakdown)
- What this could lead to
- If successful, TS23 could offer a new, safer way to dissolve dangerous blood clots in the lungs, potentially reducing complications and improving recovery.
- What could go wrong
- This is an early phase 2 trial with only 64 participants, so results may not apply to everyone. The main risk is bleeding, and the drug may not work better than standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female subjects, age \>18 years; 2. PE involving a segmental or more proximal pulmonary artery confirmed by CTPA scan and with an onset of symptoms not more than 5 days prior to diagnosis; 3. Subject is hemodynamically stable with a systolic blood pressure (SBP) \>90 mm Hg; 4. Subject has evidence of RV dysfunction as indicated by a right ventricular-to-left ventricular (RV/LV) diameter ratio \> 0.9 on CTPA scan (measuring the minor axis of the right and left ventricle in the transverse plane), prior to the initiation of study drug administration. Exclusion Criteria: 1. Subjects for whom thrombolytic therapy or thrombectomy is planned; or subjects with history of administration of thrombolytic agents within the previous 4 days; 2. Subjects receiving ≥ 48 hours of therapeutic doses of heparin or low molecular weight heparin (LMWH) or other anticoagulant therapy immediately prior to randomization; 3. Subjects with contraindications to SOC therapies such as unfractionated heparin or LMWH or oral anticoagulant, or any of the excipients (including study drug excipients); 4. Subjects who are considered at very high risk of bleeding: 1. Known coagulation disorder with history of pathologic bleeding tendencies 2. Subjects with prior intracranial hemorrhage, known arteriovenous malformation or aneurysm of the brain, or evidence of active bleeding; 3. Subjects with a history of major surgery, clinically significant head trauma (in the opinion of the Principal Investigator), or stroke in the past 3 months prior to randomization; 4. Subjects with uncontrolled hypertension defined as SBP ≥180 mm Hg and/or diastolic BP (DBP) ≥110 mm Hg at randomization 5. Subjects requiring concomitant dual antiplatelet therapy 5. Subjects with Creatinine Clearance (CrCL) \< 30 mL/min or serum creatinine ≥ 2.5 mg/dL; 6. Subjects with hemoglobin \< 8.0 g/dL; 7. Subjects with a platelet count \< 100,000/µL; 8. Subjects with acute or persistent hepatitis or diagnosed active liver disease or with elevation of liver enzymes: Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 x upper limit of normal (ULN); 9. Subjects with known history of testing positive for Hepatitis B antigen or Hepatitis C antibody; 10. Subjects with known history of testing positive for the human immunodeficiency virus (HIV); 11. Subjects with life-expectancy \< 6 months; 12. Female subjects of child bearing potential with a positive pregnancy test or who are lactating, or unwilling to use highly effective methods of contraception. Highly effective methods of birth control include combination hormonal therapy (estrogen and progresterone), contraceptives administered orally, intravaginally or transdermally, progesterone-only contraceptives administered orally, by injection or implantation, use of an intrauterine device (IUD), intrauterine hormone- releasing system (IUS), bilateral tubal occlusion, partner vasectomy or sexual abstinence; 13. Subjects currently participating in another investigational study or who have participated in an investigational drug study within 30 days (or longer depending on the half-life of the investigational drug; should allow at least five half-life of the investigational drug) prior to randomization.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary embolism are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Banner University Medical Center
Phoenix, Arizona, 85004, United States
-
Banner University Medical Center - Tucson
Tucson, Arizona, 85004, United States
-
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
-
Cleveland Clinic
Cleveland, Ohio, 44195, United States
-
Cottage Hospital
Santa Barbara, California, 93105, United States
-
Fairview Hospital
Cleveland, Ohio, 44111, United States
-
Henry Ford Hospital
Detroit, Michigan, 48207, United States
-
Lifebridge Health
Baltimore, Maryland, 21215, United States
-
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
-
Texas Tech University Health Sciences Center at El Paso
El Paso, Texas, 79430, United States
-
Tuft University Hospital
Boston, Massachusetts, 02116, United States
-
Wake Forest University/Atrium Health's Carolinas Medical Center
Winston-Salem, North Carolina, 27103, United States
-
Wellstar MCG Health Medical Center
Augusta, Georgia, 30912, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can electronic alerts and patient teaching stop deadly clots after cancer surgery?
- Can a new Five-Category system predict which pulmonary embolism patients will crash?
- A new exercise plan aims to get pulmonary embolism survivors back on their feet
- Spotting hidden blood clots in scarred lungs: a study hunts for clues
- Decades-Long study of 121,700 nurses aims to uncover hidden heart disease triggers
- Massive chest pain registry reveals gaps between guidelines and real-world care in china