Active Systemic Lupus ErythematosusPhase 2NCT07311200
A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)
A Phase 2 study testing D-2570 in people with Active Systemic Lupus Erythematosus, run by InventisBio Co., Ltd at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Systemic Lupus Erythematosus
- What is being tested?
- D-2570
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2026to 31 Dec 2028
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participates in this study after full informed consent.
- The age is 18 years ≤ age ≤ 70 years, regardless of gender.
- Diagnosed with Systemic Lupus Erythematosus (SLE) at least ≥ 24 weeks prior to screening.
- SLEDAI-2K total score ≥ 8.
- On stable treatment for systemic lupus erythematosus at least 4 weeks prior to randomization, and should remain at a stable dose throughout the trial period.
Who cannot join
- History of infection as defined in the protocol.
- Any of the medical diseases or disorders listed in the protocol.
- Significant, uncontrolled or unstable disease in any organ.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Linfen Central Hospital
Linfen, Jiangxi
Shuhua Qiang, +86 18636785653, qsh18636785653@126.com
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Patients With Active Systemic Lupus Erythematosus
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus.
Read the detailed description
Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.
- Conditions
- Active Systemic Lupus Erythematosus
- Being tested
- D-2570, D-2570 Placebo
- Keywords
- Active Systemic Lupus Erythematosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-2570Drug
Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.
D-2570 PlaceboDrug
D-2570 Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A: D-2570 and placebo | Experimental | Not described Receives: Drug: D-2570; Drug: D-2570 Placebo |
| Group B: D-2570 and placebo | Experimental | Not described Receives: Drug: D-2570; Drug: D-2570 Placebo |
| Group C: D-2570 | Experimental | Not described Receives: Drug: D-2570 |
| Placebo Control Group | Placebo comparator | Not described Receives: Drug: D-2570 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
Measured: Week 32
Secondary outcomes (13)
Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48
Measured: Weeks 4, 12, 24, and 48
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48
Measured: Weeks 4, 12, 24, 32, and 48
Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48
Measured: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10
Measured: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48
Measured: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48
Measured: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48
Measured: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48
Measured: Weeks 44-48
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody
Measured: From enrollment to the end of treatment at 48 weeks
blood drug concentration of D-2570
Measured: From enrollment to the end of treatment at 48 weeks
Incidence of adverse events rate based on NCI CTCAE V5.0
Measured: From enrollment to 52 weeks
Changes from baseline of complement (C3) levels
Measured: From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement C4 levels
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start12 Feb 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaofeng, Principal investigator, Zeng
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311200
- Sponsor's protocol ID
- D2570-205
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Patients With Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07311200
- Acronym / sponsor ID
- D2570-205
- Conditions
- Active Systemic Lupus Erythematosus
- Keywords
- Active Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Dec 2025 (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 study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus.
Detailed description
Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: D-2570 and placebo | Experimental | Drug: D-2570, Drug: D-2570 Placebo |
| Group B: D-2570 and placebo | Experimental | Drug: D-2570, Drug: D-2570 Placebo |
| Group C: D-2570 | Experimental | Drug: D-2570 |
| Placebo Control Group | Placebo comparator | Drug: D-2570 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient voluntarily participates in this study after full informed consent.
- The age is 18 years ≤ age ≤ 70 years, regardless of gender.
- Diagnosed with Systemic Lupus Erythematosus (SLE) at least ≥ 24 weeks prior to screening.
- SLEDAI-2K total score ≥ 8.
- On stable treatment for systemic lupus erythematosus at least 4 weeks prior to randomization, and should remain at a stable dose throughout the trial period.
Key exclusion criteria (3 listed)
- History of infection as defined in the protocol.
- Any of the medical diseases or disorders listed in the protocol.
- Significant, uncontrolled or unstable disease in any organ.
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 |
|---|---|---|
| D-2570Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group. | Drug | Group A: D-2570 and placebo, Group B: D-2570 and placebo, Group C: D-2570 |
| D-2570 PlaceboD-2570 Placebo | Drug | Group A: D-2570 and placebo, Group B: D-2570 and placebo, Placebo Control Group |
Primary outcome
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
Time frame: Week 32
13 secondary outcomes
Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48
Time frame: Weeks 4, 12, 24, and 48
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48
Time frame: Weeks 44-48
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody
Time frame: From enrollment to the end of treatment at 48 weeks
blood drug concentration of D-2570
Time frame: From enrollment to the end of treatment at 48 weeks
Incidence of adverse events rate based on NCI CTCAE V5.0
Time frame: From enrollment to 52 weeks
Changes from baseline of complement (C3) levels
Time frame: From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement C4 levels
Time frame: From enrollment to the end of treatment at 48 weeks
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 24 Apr 2026.
- 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.
Xiaofeng principal investigator
Zeng
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 D-2570 in people with Active Systemic Lupus Erythematosus, run by InventisBio 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 5 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: looking for participants now, as of the sponsor's last update on 24 Apr 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. 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?
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?
Contact Hang Ren, Master (86+15900699091, hang.ren@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32 (time frame: Week 32). 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 24 Apr 2026.