Antiphospholipid Syndrome (APS)Phase 1NCT07632976
A Phase I, Dose Escalation, Open-label, Multicenter Study of EA5 Injection in Adults With APS and Recurrent Thrombosis
A Phase 1 study testing EA5 in people with Antiphospholipid Syndrome (APS) and Thrombosis, run by Shanghai Lanyi Therapeutics Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome (APS), Thrombosis
- What is being tested?
- EA5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- Use of contraception by men and women should be consistent with local regulations regarding contraceptive methods for clinical trial participants.
- (1)Male Participants: Male participants must agree to use effective contraception during the treatment period and for at least 6 months after the last dose of the study intervention, and to refrain from donating sperm during this time.
- (2)Female Participants: Non-pregnant, non-lactating female participants are eligible to participate if they meet at least one of the following conditions: use of an effective or acceptable contraceptive method during the treatment period and for at least 6 months after the last dose of the study drug.
- Capable of understanding the study procedures and methods, willing to sign the ICF, and able to strictly adhere to the clinical study protocol to complete the study.
Who cannot join
- 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.
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- Comorbid with systemic autoimmune diseases (e.g., systemic lupus erythematosus, systemic sclerosis, etc.).
- Unresolved meningococcal infection.
- Positive for hepatitis C virus (HCV) antibody at screening (except for those with a negative HCV RNA result), positive for human immunodeficiency virus (HIV) antibody, positive for anti-Treponema pallidumantibody (TP-Ab) (except for those with a negative RPR or TRUST test), OR positive for hepatitis B virus (HBV) surface antigen (HBsAg) (except for those with an HBV DNA level ≤ 1000 IU/mL).
- Presence of active infection requiring systemic therapy within 4 weeks prior to the first use of the investigational product (including herpes zoster, active tuberculosis, active Treponema palliduminfection, and fungal infections requiring systemic therapy).
- Participants with severe hepatic or renal impairment: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal (ULN); total bilirubin ≥ 2 times ULN; serum creatinine ≥ 2.5 times ULN, OR calculated creatinine clearance ≤ 30 mL/min according to the Cockcroft-Gault formula.
- Receipt of other interventional therapy or participation in another clinical study within 30 days prior to the first use of the investigational product or within 5 half-lives of this investigational product (whichever is longer).
- Prior use of complement C3 or C5 targeted therapy.
- History of allergy to any component of EA5, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.
- Any disease that, in the opinion of the investigator or sponsor, may increase participant risk or confound study outcomes. Including, but not limited to, significant circulatory, respiratory, urinary, endocrine system diseases, etc.
- Female participants who are pregnant or breastfeeding.
- Any other condition for which the investigator considers the participant unsuitable to enter this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Phase I, Dose Escalation, Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacodynamics, and Pharmacokinetics of EA5 Injection in Adult Participants With Antiphospholipid Syndrome (APS) and Recurrent Thrombosis Under Standard-of-Care Background Therapy
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.
- Conditions
- Antiphospholipid Syndrome (APS), Thrombosis
- Being tested
- EA5
- Keywords
- EA5, Antiphospholipid Syndrome(APS),, Recurrent Thrombosis
- Medical subject headings
- Antiphospholipid Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA5Biological
Administer the loading dose regimen intravenously, then maintain administration subcutaneously
EA5Biological
Administer the loading dose regimen intravenously, then maintain administration subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Queue 1: Administration of low-dose EA5 First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Receives: Biological: EA5 |
| Cohort 2 | Experimental | Queue 2: Administration of high-dose EA5 First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Receives: Biological: EA5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Week28
Secondary outcomes (14)
Number of participants with adjudicated thrombotic events during the treatment period (including venous, arterial, and small-vessel thrombotic events)
Measured: Baseline up to Week28
Number of adjudicated thrombotic events per participant
Measured: Baseline up to Week28
Change in annualized thrombosis event rate compared to baseline (the 5-year period prior to treatment)
Measured: Baseline up to Week28
Change in platelet count from baseline at each visit
Measured: Baseline up to Week28
Situations requiring adjustment of antithrombotic treatment regimen during the treatment period
Measured: Baseline up to Week28
Change in levels of sC5b-9 before and after dosing
Measured: Baseline up to Week28
Change in levels of free C5 before and after dosing
Measured: Baseline up to Week28
Incidence of anti-drug antibodies (ADA) against the humanized monoclonal antibody EA5
Measured: Baseline up to Week28
Maximum Observed Serum Concentration (Cmax) of EA5
Blood samples were collected for analysis of Cmax
Measured: Baseline up to Week28
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Blood samples were collected for analysis of Tmax
Measured: Baseline up to Week 28
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Blood samples were collected for analysis of AUC0-t
Measured: Baseline up to Week 28
Terminal Elimination Rate Constant (λz) of Serum EA5
Blood samples were collected for analysis of λz
Measured: Baseline up to Week 28
Terminal Elimination Half-life (t½) of Serum EA5
Blood samples were collected for analysis of t½
Measured: Baseline up to Week 28
Total Clearance (CL) of EA5
Blood samples were collected for analysis of CL
Measured: Baseline up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start25 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome (APS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632976
- Sponsor's protocol ID
- C-EA5-2501
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Escalation, Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacodynamics, and Pharmacokinetics of EA5 Injection in Adult Participants With Antiphospholipid Syndrome (APS) and Recurrent Thrombosis Under Standard-of-Care Background Therapy
- ClinicalTrials.gov ID
- NCT07632976
- Acronym / sponsor ID
- C-EA5-2501
- Conditions
- Antiphospholipid Syndrome (APS), Thrombosis
- Keywords
- EA5, Antiphospholipid Syndrome(APS),, Recurrent Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: EA5Queue 1: Administration of low-dose EA5 First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). |
| Cohort 2 | Experimental | Biological: EA5Queue 2: Administration of high-dose EA5 First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EA5Administer the loading dose regimen intravenously, then maintain administration subcutaneously | Biological | Cohort 1 |
| EA5Administer the loading dose regimen intravenously, then maintain administration subcutaneously | Biological | Cohort 2 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week28
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
14 secondary outcomes
Number of participants with adjudicated thrombotic events during the treatment period (including venous, arterial, and small-vessel thrombotic events)
Time frame: Baseline up to Week28
Number of adjudicated thrombotic events per participant
Time frame: Baseline up to Week28
Change in annualized thrombosis event rate compared to baseline (the 5-year period prior to treatment)
Time frame: Baseline up to Week28
Change in platelet count from baseline at each visit
Time frame: Baseline up to Week28
Situations requiring adjustment of antithrombotic treatment regimen during the treatment period
Time frame: Baseline up to Week28
Change in levels of sC5b-9 before and after dosing
Time frame: Baseline up to Week28
Change in levels of free C5 before and after dosing
Time frame: Baseline up to Week28
Incidence of anti-drug antibodies (ADA) against the humanized monoclonal antibody EA5
Time frame: Baseline up to Week28
Maximum Observed Serum Concentration (Cmax) of EA5
Time frame: Baseline up to Week28
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Time frame: Baseline up to Week 28
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Time frame: Baseline up to Week 28
Terminal Elimination Rate Constant (λz) of Serum EA5
Time frame: Baseline up to Week 28
Terminal Elimination Half-life (t½) of Serum EA5
Time frame: Baseline up to Week 28
Total Clearance (CL) of EA5
Time frame: Baseline up to Week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EA5 in people with Antiphospholipid Syndrome (APS) and Thrombosis, run by Shanghai Lanyi Therapeutics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Week28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.