Systemic Lupus ErythematosusPhase 2NCT05929248
Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia
A Phase 2 study testing Telitacicept and conventional therapy in people with Systemic Lupus Erythematosus, run by Guanmin Gao.
Trial summary
The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Telitacicept and conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 30 Dec 2024
- 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
- Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus;
- Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug);
- SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is<10 * 10 ^ 9/L or<30 * 10 ^ 9/L with bleeding tendency;
- Age greater than or equal to 18 years old and less than or equal to 65 years old;
- Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody;
- 7. Sign informed documents.
Who cannot join
- Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
- Patients who are allergic to tamoxifen;
- Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation;
- Patients with severe active central nervous system lupus and severe active lupus nephritis
- Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system;
- Pregnant and lactating women;
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- Have a pregnancy preparation plan in the past year;
- Those who have merged with other autoimmune diseases;
- Incomplete case data and missing persons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia
Read the detailed description
This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Telitacicept, conventional therapy, Placebo
- Keywords
- lupus erythematosus, Telitacicept, thrombocytopenia
- Medical subject headings
- Lupus Erythematosus, Systemic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
Also called RC18
160mg once a week for 48 weeks
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
PlaceboDrug
Used once a week in combination with standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | conventional treatment plus Telitacicept 160 mg sc per week Receives: Drug: Telitacicept; Drug: conventional therapy |
| Control group | Placebo comparator | Placebo plus conventional treatment Receives: Drug: conventional therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate of SLE response index at month 12 of treatment
Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
Measured: months 12
Improvement in platelet count
Platelet count at month of treatment，Increased platelet count indicates improvement in disease
Measured: months 12
Secondary outcomes (3)
Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12
A decrease of ≥ 4 points from baseline in the SELENA-SLEDAI score indicates a good drug response effect
Measured: months 6 and 12
Hormone reduction
Changes in patient hormone dose from baseline at month 12，reduced hormone dosage indicates improvement in disease
Measured: month 12
B lymphocyte count
Changes in patient B lymphocyte count from baseline at month 12
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guanmin Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guanmin Gao, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Gao Guanmin, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929248
- Sponsor's protocol ID
- GGao
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Aimed at Exploring the Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus Patients With Refractory Thrombocytopenia
- ClinicalTrials.gov ID
- NCT05929248
- Acronym / sponsor ID
- GGao
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- lupus erythematosus, Telitacicept, thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Guanmin GaoUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia
Detailed description
This study is a single center, randomized, controlled trial to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus complicated with refractory thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Telitacicept, Drug: conventional therapyconventional treatment plus Telitacicept 160 mg sc per week |
| Control group | Placebo comparator | Drug: conventional therapy, Drug: PlaceboPlacebo plus conventional treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets the 2012 ACR revised standards and meets four or more diagnostic criteria for systemic lupus erythematosus;
- Refractory thrombocytopenia (defined as receiving at least one course of methylprednisolone pulse therapy or intravenous injection of high-dose immunoglobulin or high-dose glucocorticoid combined with two or more Immunosuppressive drug failed and did not respond to any single drug);
- SLEENA-SLEDAI score is greater than or equal to 8 points. If anti ds-DNA antibody is positive and/or low complement, SLEENA-SLEDAI score is greater than or equal to 6 points, or PLT count is<10 * 10 ^ 9/L or<30 * 10 ^ 9/L with bleeding tendency;
- Age greater than or equal to 18 years old and less than or equal to 65 years old;
- Have a stable SLE treatment plan, and participants should receive standard treatment for at least 30 days before randomization; 6. Positive Antinuclear antibody or anti ds DNA antibody;
Key exclusion criteria (9 listed)
- Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:
- Patients who are allergic to tamoxifen;
- Patients with severe active infection, history of tuberculosis, malignant tumor, HIV, hepatitis B, hepatitis C, important organs or hematopoietic stem cells/cells/bone marrow transplantation or kidney transplantation;
- Patients with severe active central nervous system lupus and severe active lupus nephritis
- Patients with diseases of liver, kidney, heart and other important organs, blood and Endocrine system;
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: RC18160mg once a week for 48 weeks | Drug | Treatment group |
| conventional therapySteroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc. | Drug | Control group, Treatment group |
| PlaceboUsed once a week in combination with standard treatment | Drug | Control group |
Primary outcome
The remission rate of SLE response index at month 12 of treatment
Time frame: months 12
Use SRI-4 to represent the response index, with a higher response rate indicating better drug efficacy
Improvement in platelet count
Time frame: months 12
Platelet count at month of treatment，Increased platelet count indicates improvement in disease
3 secondary outcomes
Percentage of patients with a decrease of ≥ 4 points in the SELENA-SLEDAI score from baseline at months 6 and 12
Time frame: months 6 and 12
Hormone reduction
Time frame: month 12
B lymphocyte count
Time frame: month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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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.
Gao Guanmin principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept and conventional therapy in people with Systemic Lupus Erythematosus, run by Guanmin Gao.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao Guanmin (13613716851, Guanmingao@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The remission rate of SLE response index at month 12 of treatment (time frame: months 12). The study lists 2 primary outcomes in all. 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 3 Jul 2023.