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RecruitingNCT07010835Updated Feb 5, 2026

Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus

A Phase 1/2 interventional study of YK012 in Systemic Lupus Erythematosus (SLE), sponsored by Excyte Biopharma Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Excyte Biopharma Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
189
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Systemic Lupus Erythematosus (SLE)
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 189 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Excyte Biopharma Ltd is the lead sponsor of 7 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    YK012

    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.

    Drug: YK012

Interventions

  • DrugYK012

    YK012 is a bispecific antibody targeting CD19 and CD3.

06

What researchers measure

Primary outcomes

  1. Ib dose escalation stage: Dose Limiting Toxicity (DLT)

    Time frame: From the first infusion of YK012 to Day 28 post first infusion

  2. 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.

    Time frame: From the first infusion of YK012 to the end of trial at 48 weeks

  3. 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.

    Time frame: From the first infusion of YK012 to the end of trial at 48 weeks

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. Maximum Concentration (Cmax) of YK012

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  4. Time to Reach Cmax (Tmax)

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  5. Elimination Half Life (t1/2)

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  6. Apparent Clearance (CL)

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  7. Apparent volume of distribution (Vd)

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  8. Minimum Concentration (Cmin) of YK012

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  9. Phase II: Characteristics of peripheral blood B-cell changes

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  10. 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

  11. Changes in anti-dsDNA antibody level from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  12. Changes in complement C3 level from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  13. Changes in complement C4 level from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  14. Changes in IgG level from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  15. Changes in IgM level from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  16. Changes in IgA levels from baseline

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  17. Anti-Drug Antibody (ADA) positivity rate

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  18. Neutralizing antibody (Nab) positivity rate

    Time frame: From pre-dose of YK012 to the end of trial at 48 weeks

  19. 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

  20. BILAG-based Composite Lupus Assessment (BICLA) response rates

    Time frame: From screening to the end of trial at 48 weeks

  21. 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

  22. Proportion of patients achieving Lupus Low Disease Activity State (LLDAS)

    Time frame: From screening to the end of trial at 48 weeks

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Change in Physician's Global Assessment (PGA) score from baseline

    Time frame: From screening to the end of trial at 48 weeks

  30. 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

  31. Change in Fatigue Severity Scale (FSS) score from baseline

    Time frame: From screening to the end of trial at 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07010835
Lead sponsor
Excyte Biopharma Ltd
Responsible party
Sponsor
First posted
Jun 8, 2025
Start date
Aug 25, 2025
Primary completion
Jun 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 5, 2026

Study contacts

Xiaofeng Zeng, Doctor of Medicine
Contact
xiaofeng.zeng@cstar.org.cn
+86 13501069845

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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