Anti Phospholipid SyndromePhase 2NCT05078710
Telitacicept in Primary APS Patients
A Phase 2 study testing Telitacicept in people with Anti Phospholipid Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anti Phospholipid Syndrome
- What is being tested?
- Telitacicept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet 2006 Sapporo classification criteria of APS;
- diagnosis of primary APS, exclude other etiologies of thrombosis;
- with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
- with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.
Who cannot join
- overlap with other connective tissue diseases, such as systemic lupus erythematosus;
- during pregnancy;
- can not follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Pilot Study of Telitacicept Treatment in Primary APS Patients
This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.
Read the detailed description
The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.
- Conditions
- Anti Phospholipid Syndrome
- Being tested
- Telitacicept
- Keywords
- anti phospholipid syndrome
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Also called traditional antithrombotic and immunosuppressive treatment
160mg once a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept arm | Experimental | Telitacicept 160mg once a week for 24 week as an add-on treatment regimen. Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
new thrombotic event
any new thrombotic event during Telitacicept treatment
Measured: 24 weeks
Secondary outcomes (6)
improvement of thrombocytopenia during Telitacicept treatment
elevated platelet counts
Measured: 24 weeks
improvement of hemolytic anemia during Telitacicept treatment
elevated hemoglobin
Measured: 24 weeks
improvement of aPL nephropathy during Telitacicept treatment
decrease of proteinuria or creatinine
Measured: 24 weeks
improvement of valve heart disease during Telitacicept treatment
decrease of valve thickness or vegetation by echocardiogram
Measured: 24 weeks
improvement of neurological manifestations during Telitacicept treatment
MRI improvement
Measured: 24 weeks
decrease of aPL titer during Telitacicept treatment
titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion1 Jun 2025
Why it stopped: There is no clear therapeutic effect among the enrolled patients for the time being.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti Phospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiuliang Zhao, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078710
- Sponsor's protocol ID
- PUMCH-ZS-3026
- Status last verified
- Jul 2021
- First submitted
- 24 Sep 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Telitacicept Treatment in Primary APS Patients
- ClinicalTrials.gov ID
- NCT05078710
- Acronym / sponsor ID
- PUMCH-ZS-3026
- Conditions
- Anti Phospholipid Syndrome
- Keywords
- anti phospholipid syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There is no clear therapeutic effect among the enrolled patients for the time being.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 Oct 2021 (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 single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.
Detailed description
The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telitacicept arm | Experimental | Drug: TelitaciceptTelitacicept 160mg once a week for 24 week as an add-on treatment regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet 2006 Sapporo classification criteria of APS;
- diagnosis of primary APS, exclude other etiologies of thrombosis;
- with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
- with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.
Key exclusion criteria (3 listed)
- overlap with other connective tissue diseases, such as systemic lupus erythematosus;
- during pregnancy;
- can not follow-up.
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 |
|---|---|---|
| TelitaciceptAlso: traditional antithrombotic and immunosuppressive treatment160mg once a week for 24 weeks | Drug | Telitacicept arm |
Primary outcome
new thrombotic event
Time frame: 24 weeks
any new thrombotic event during Telitacicept treatment
6 secondary outcomes
improvement of thrombocytopenia during Telitacicept treatment
Time frame: 24 weeks
improvement of hemolytic anemia during Telitacicept treatment
Time frame: 24 weeks
improvement of aPL nephropathy during Telitacicept treatment
Time frame: 24 weeks
improvement of valve heart disease during Telitacicept treatment
Time frame: 24 weeks
improvement of neurological manifestations during Telitacicept treatment
Time frame: 24 weeks
decrease of aPL titer during Telitacicept treatment
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: There is no clear therapeutic effect among the enrolled patients for the time being.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jiuliang Zhao, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept in people with Anti Phospholipid Syndrome, run by Peking Union Medical College Hospital 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Jun 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: There is no clear therapeutic effect among the enrolled patients for the time being.). Results are not available in the source record.
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?
new thrombotic event (time frame: 24 weeks). 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 2025.