A Phase I, Dose Escalation, Open-label, Multicenter Study of EA5 Injection in Adults With APS and… (NCT07632976) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Phase I, Dose Escalation, Open-label, Multicenter Study of EA5 Injection in Adults With APS and Recurrent Thrombosis
China12 participantsStarted 2026-05-25
Plain-language summary
This is a Phase I, open-label, dose escalation, multicenter study to evaluate the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of EA5 injection in adult participants with Antiphospholipid Syndrome (APS) and recurrent thrombosis who are receiving standard-of-care antithrombotic therapy. Approximately 12 participants will be enrolled. The whole study treatment cycle was 24 weeks. Administration of low-dose EA5: First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Administration of high-dose EA5: First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of preliminary efficacy, immunogenicity, PK, PD (complement inhibition), and APS-related biomarker changes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
. Participants diagnosed with Antiphospholipid Syndrome (APS) according to the 2023 EULAR/ACR classification criteria, with at least two of the three antiphospholipid antibodies positive: anticardiolipin antibody (aCL), anti-β2-glycoprotein I antibody (anti-β2GPI), and lupus anticoagulant (LA).
. Experienced ≥2 thrombotic events within the past 5 years under antithrombotic prophylactic therapy, confirmed by objective imaging.
. Stable antithrombotic treatment regimen for at least 6 months prior to screening (dose adjustment of warfarin to achieve a stable INR is permitted).
. Vaccination against Neisseria meningitidis (MPV-ACYW) within \<3 years prior to initiation of study treatment; OR if not previously vaccinated, receipt of the meningococcal vaccine (MPV-ACYW) at least 14 days prior to the first dose of the investigational product. If the vaccine is administered within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
. Vaccination against Streptococcus pneumoniae according to national vaccination recommendations (e.g., Advisory Committee on Immunization Practices \[ACIP\] guidelines). OR if not previously vaccinated, receipt of the pneumococcal vaccine at least 14 days prior to the first dose of the investigational product. If the vaccine is administered within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination.
. Use of contraception by men and women should be consistent with local regulations regarding contraceptive methods for clinical trial participants.
Exclusion criteria
. History of malignancy within 5 years prior to screening and before administration (except for localized skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ that have undergone curative local treatment with no evidence of metastasis in the past 3 years).
. Thrombosis with other definite etiologies, such as malignancy, hereditary thrombophilia, thrombotic microangiopathy, etc.
. History of catastrophic antiphospholipid syndrome (i.e., progressive thrombosis in multiple \[3 or more\] organs occurring within 1 week, involving critical organs such as the brain, kidneys, liver, or heart leading to failure, with pathological confirmation of small vessel thrombosis).
. Presence of active bleeding or high risk of bleeding, such as gastrointestinal bleeding, intracranial bleeding, respiratory tract bleeding, coagulation disorders, etc.
. History of major surgery within 1 month prior to screening or requiring major elective surgery during the trial period.
. History of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibody, or having other acquired or congenital immunodeficiency diseases.