Systemic Lupus Erythematosus (SLE)Phase 1/2NCT07010835
Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
A Phase 1/2 study testing YK012 in people with Systemic Lupus Erythematosus (SLE), run by Excyte Biopharma Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- YK012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to Dec 2028
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive) at screening, regardless of sex
- Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening
- Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site
- Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7
- Receiving stable background therapy at screening
- Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures.
Who cannot join
- Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components
- Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment
- Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment
- Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment
- Used traditional Chinese medicines/herbal preparations for SLE treatment containing within 2 weeks prior to enrollment
- Received live or attenuated vaccines within 1 month prior to enrollment
Show all 25Show fewer
- Has other autoimmune diseases, inflammatory joint diseases, or skin disorders (other than SLE) that may interfere with disease activity assessment
- History of malignancy within 5 years before screening, except for cured cases with no recurrence for at least 5 years, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of breast, or papillary thyroid cancer
- Clinically significant cardiovascular/cerebrovascular diseases within 6 months prior to screening
- Presence of QTcF interval prolongation on electrocardiogram (ECG)
- Presence of poorly controlled hypertension at screening
- History of non-SLE conditions requiring oral/intravenous/intramuscular/subcutaneous corticosteroid therapy (>2 weeks) within 6 months prior to enrollment
- Active tuberculosis at screening or untreated latent tuberculosis
- History of solid organ or bone marrow transplantation
- Presence of active infections
- Lupus nephritis requiring protocol-prohibited medications as assessed by the investigator
- Uncontrolled lupus crisis within 8 weeks prior to screening
- History of central nervous system (CNS) disorders
- Presence of clinically unstable or uncontrolled medical conditions at screening
- Presence of clinically significant abnormal laboratory test results
- Presence of active viral infections (e.g., hepatitis B, hepatitis C, HIV, or active syphilis)
- Had major surgery within 4 weeks prior to enrollment or planned during study;
- Participation in other interventional clinical trials within 4 weeks prior to enrollment
- Pregnant or lactating women, or individuals with pregnancy plans during the study and within a specified period after treatment who are unwilling to use effective contraception
- Other conditions deemed by investigators to preclude study participation.
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaofeng Zeng, Doctor of Medicine, +86 13501069845, xiaofeng.zeng@cstar.org.cn
About this study
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Moderate to Severe Systemic Lupus Erythematosus
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Read the detailed description
This clinical trial consists of Phase Ib and Phase II. Phase Ib consists of dose escalation stage and dose expansion stage. The main goal of dose escalation stage is to evaluate the safety and tolerability of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE), and the main goal of dose expansion stage is to evaluate the safety, tolerability and effectiveness in reducing disease activity of YK012 in participants with SLE. The main goal of phase II is to assess the efficacy of YK012 in participants with Moderate to Severe SLE. Pharmacokinetics, pharmacodynamics and immunogenicity of YK012 in participants are evaluated as secondary objectives in both phases.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- YK012
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YK012Drug
YK012 is a bispecific antibody targeting CD19 and CD3.
| Study group | Role | What they receive |
|---|---|---|
| YK012 | Experimental | Phase Ib: Participants will receive four different target doses of YK012 in dose escalation stage to evaluate its safety and tolerability. Participants will receive two to three different target doses of YK012 in dose expansion stage to further evaluate its safety, tolerability and effectiveness in reducing disease activity. Phase II: Participants will receive either placebo or one to two different doses of YK012. The specific doses will be determined based on prior clinical trial results. Receives: Drug: YK012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ib dose escalation stage: Dose Limiting Toxicity (DLT)
Measured: From the first infusion of YK012 to Day 28 post first infusion
Adverse Event (AE)
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Measured: From the first infusion of YK012 to the end of trial at 48 weeks
Severe Adverse Event (SAE)
An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.
Measured: From the first infusion of YK012 to the end of trial at 48 weeks
Ib dose expansion stage and phase II: SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response rates
Measured: From the first infusion of YK012 to the end of trial at 48 weeks
Secondary outcomes (31)
Area Under the Curve (AUC0-t) of a serum concentration versus time profile
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Area under the blood concentration-time curve from zero to infinity (AUC0-∞)
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Maximum Concentration (Cmax) of YK012
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Time to Reach Cmax (Tmax)
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Elimination Half Life (t1/2)
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Apparent Clearance (CL)
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Apparent volume of distribution (Vd)
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Minimum Concentration (Cmin) of YK012
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Phase II: Characteristics of peripheral blood B-cell changes
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Change in urinary protein from baseline in patients with positive urinary protein during the trial
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in anti-dsDNA antibody level from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in complement C3 level from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in complement C4 level from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgG level from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgM level from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgA levels from baseline
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Anti-Drug Antibody (ADA) positivity rate
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Neutralizing antibody (Nab) positivity rate
Measured: From pre-dose of YK012 to the end of trial at 48 weeks
Ib dose escalation stage: Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response rates
Measured: From screening to the end of trial at 48 weeks
BILAG-based Composite Lupus Assessment (BICLA) response rates
Measured: From screening to the end of trial at 48 weeks
Proportion of patients achieving disease remission as defined by Definition of Remission in SLE (DORIS)
Measured: From screening to the end of trial at 48 weeks
Proportion of patients achieving Lupus Low Disease Activity State (LLDAS)
Measured: From screening to the end of trial at 48 weeks
Proportion of patients with baseline Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score ≥10 who achieved ≥50% improvement in CLASI (CLASI-50) during the trial
Measured: From screening to the end of trial at 48 weeks
Proportion of patients with baseline ≥4 swollen and/or tender joints who achieved ≥50% improvement in joint count during the trial
Measured: From screening to the end of trial at 48 weeks
Proportion and duration of patients with baseline glucocorticoid dosage >5mg/day prednisone (or equivalent) achieving dosage ≤5mg/day prednisone (or equivalent)
Measured: From screening to the end of trial at 48 weeks
Time to relapse after achieving Lupus Low Disease Activity State (LLDAS) during the trial
Measured: From screening to the end of trial at 48 weeks
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline
Measured: From screening to the end of trial at 48 weeks
Change in British Isles Lupus Assessment Group 2004 (BILAG-2004) score from baseline
Measured: From screening to the end of trial at 48 weeks
Change in Physician's Global Assessment (PGA) score from baseline
Measured: From screening to the end of trial at 48 weeks
Change in 36-Item Short Form Health Survey (SF-36) score from baseline
Measured: From screening to the end of trial at 48 weeks
Change in Fatigue Severity Scale (FSS) score from baseline
Measured: From screening to the end of trial 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 posted8 Jun 2025
- Study start25 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excyte Biopharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010835
- Sponsor's protocol ID
- YK012-4
- Status last verified
- Feb 2026
- First submitted
- 30 May 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Moderate to Severe Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07010835
- Acronym / sponsor ID
- YK012-4
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Excyte Biopharma LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 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.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Detailed description
This clinical trial consists of Phase Ib and Phase II. Phase Ib consists of dose escalation stage and dose expansion stage. The main goal of dose escalation stage is to evaluate the safety and tolerability of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE), and the main goal of dose expansion stage is to evaluate the safety, tolerability and effectiveness in reducing disease activity of YK012 in participants with SLE. The main goal of phase II is to assess the efficacy of YK012 in participants with Moderate to Severe SLE. Pharmacokinetics, pharmacodynamics and immunogenicity of YK012 in participants are evaluated as secondary objectives in both phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YK012 | Experimental | Drug: YK012Phase Ib: Participants will receive four different target doses of YK012 in dose escalation stage to evaluate its safety and tolerability. Participants will receive two to three different target doses of YK012 in dose expansion stage to further evaluate its safety, tolerability and effectiveness in reducing disease activity. Phase II: Participants will receive either placebo or one to two different doses of YK012. The specific doses will be determined based on prior clinical trial results. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years (inclusive) at screening, regardless of sex
- Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening
- Positive for anti-dsDNA antibody and/or antinuclear antibody (ANA) and/or anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site
- Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7
- Receiving stable background therapy at screening
Key exclusion criteria (25 listed)
- Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components
- Received any anti-CD19/CD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment
- Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment
- Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment
- Used traditional Chinese medicines/herbal preparations for SLE treatment containing within 2 weeks prior to enrollment
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 |
|---|---|---|
| YK012YK012 is a bispecific antibody targeting CD19 and CD3. | Drug | YK012 |
Primary outcome
Ib dose escalation stage: Dose Limiting Toxicity (DLT)
Time frame: From the first infusion of YK012 to Day 28 post first infusion
Adverse Event (AE)
Time frame: From the first infusion of YK012 to the end of trial at 48 weeks
An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.
Severe Adverse Event (SAE)
Time frame: From the first infusion of YK012 to the end of trial at 48 weeks
An SAE refers to any untoward medical occurrence after the participant receives the IMP that results in one or more of the following: death, life-threatening event, permanent or serious disability or loss of function, hospitalization or prolongation of hospitalization, congenital abnormalities or birth defects.
Ib dose expansion stage and phase II: SRI-4 (Systemic Lupus Erythematosus Responder Index-4) response rates
Time frame: From the first infusion of YK012 to the end of trial at 48 weeks
31 secondary outcomes
Area Under the Curve (AUC0-t) of a serum concentration versus time profile
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Area under the blood concentration-time curve from zero to infinity (AUC0-∞)
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Maximum Concentration (Cmax) of YK012
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Time to Reach Cmax (Tmax)
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Elimination Half Life (t1/2)
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Apparent Clearance (CL)
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Apparent volume of distribution (Vd)
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Minimum Concentration (Cmin) of YK012
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Phase II: Characteristics of peripheral blood B-cell changes
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Change in urinary protein from baseline in patients with positive urinary protein during the trial
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in anti-dsDNA antibody level from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in complement C3 level from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in complement C4 level from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgG level from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgM level from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Changes in IgA levels from baseline
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Anti-Drug Antibody (ADA) positivity rate
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Neutralizing antibody (Nab) positivity rate
Time frame: From pre-dose of YK012 to the end of trial at 48 weeks
Ib dose escalation stage: Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response rates
Time frame: From screening to the end of trial at 48 weeks
BILAG-based Composite Lupus Assessment (BICLA) response rates
Time frame: From screening to the end of trial at 48 weeks
Proportion of patients achieving disease remission as defined by Definition of Remission in SLE (DORIS)
Time frame: From screening to the end of trial at 48 weeks
Proportion of patients achieving Lupus Low Disease Activity State (LLDAS)
Time frame: From screening to the end of trial at 48 weeks
Proportion of patients with baseline Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score ≥10 who achieved ≥50% improvement in CLASI (CLASI-50) during the trial
Time frame: From screening to the end of trial at 48 weeks
Proportion of patients with baseline ≥4 swollen and/or tender joints who achieved ≥50% improvement in joint count during the trial
Time frame: From screening to the end of trial at 48 weeks
Proportion and duration of patients with baseline glucocorticoid dosage >5mg/day prednisone (or equivalent) achieving dosage ≤5mg/day prednisone (or equivalent)
Time frame: From screening to the end of trial at 48 weeks
Time to relapse after achieving Lupus Low Disease Activity State (LLDAS) during the trial
Time frame: From screening to the end of trial at 48 weeks
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline
Time frame: From screening to the end of trial at 48 weeks
Change in British Isles Lupus Assessment Group 2004 (BILAG-2004) score from baseline
Time frame: From screening to the end of trial at 48 weeks
Change in Physician's Global Assessment (PGA) score from baseline
Time frame: From screening to the end of trial at 48 weeks
Change in 36-Item Short Form Health Survey (SF-36) score from baseline
Time frame: From screening to the end of trial at 48 weeks
Change in Fatigue Severity Scale (FSS) score from baseline
Time frame: From screening to the end of trial 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 5 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YK012 in people with Systemic Lupus Erythematosus (SLE), run by Excyte Biopharma 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 6 inclusion and 25 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 5 Feb 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 combined 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.
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 Xiaofeng Zeng, Doctor of Medicine (+86 13501069845, xiaofeng.zeng@cstar.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ib dose escalation stage: Dose Limiting Toxicity (DLT) (time frame: From the first infusion of YK012 to Day 28 post first infusion). The study lists 4 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 5 Feb 2026.