Systemic Lupus Erythematosus study: JY231 injection
Official title JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)
ClinicalTrials.gov ID: NCT06675422
What this study is testing
What is JY231 injection?
an investigational intravenous medicine being studied as a potential treatment for active systemic lupus erythematosus (SLE)
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at whether JY231 is safe, well‑tolerated, and shows any early benefit for active SLE.
- Who it's for
- Adults who have active systemic lupus erythematosus.
- What's involved
- Participants will receive the JY231 injection and attend study visits for safety labs, physical exams, and other assessments.
- Time commitment
- The trial runs for a few months and requires several clinic visits during that time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 75
You may be able to join if
- Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or...
- Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have...
- positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening.
- ≥1 organ system BILAG2004 grade A disease
- ≥2 organ system BILAG2004 Grade B disorders 6.Physician's General Assessment (PGA) score of ≥1.0 (0-3 visual analogue scale VAS) at screening.
You likely can't join if
- Combination of other autoimmune diseases requiring systemic therapy.
- SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe...
- Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not...
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for...
- Presence of clinically significant cardiovascular dysfunction in the 12 months prior to screening, including, but not limited to: class III or IV...
- Presence of significant pulmonary or cardiac manifestations such as pericarditis, pleural effusion at the time of screening, assessed by the...
See the full eligibility criteria
Who can join
- Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical...
- Must have been treated with glucocorticoids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening and have been dose stable for \>2 weeks, with the disease remaining active...
- positive anti-nuclear antibody (ANA), and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody at screening.
- ≥1 organ system BILAG2004 grade A disease
- ≥2 organ system BILAG2004 Grade B disorders 6.Physician's General Assessment (PGA) score of ≥1.0 (0-3 visual analogue scale VAS) at screening.
What rules you out
- Combination of other autoimmune diseases requiring systemic therapy.
- SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe neuropsychiatric lupus, severe haemolytic anaemia, severe immune...
- Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not limited to: cerebral vascular accident, aneurysm, epilepsy...
- History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for such transplantation.
- Presence of clinically significant cardiovascular dysfunction in the 12 months prior to screening, including, but not limited to: class III or IV heart failure as defined by the New York Heart Association (NYHA)...
- Presence of significant pulmonary or cardiac manifestations such as pericarditis, pleural effusion at the time of screening, assessed by the investigator to be unsuitable for participation in this study.
- Patients with severe asthma or chronic obstructive pulmonary disease (COPD), mild or moderate asthma or COPD on stable therapy may be enrolled.
- History of malignancy within 5 years prior to signing the Informed Consent Form (ICF), except adequately treated or surgically resected, non-melanoma skin cancers or carcinoma in situ (e.g., cervical cancer, bladder...
- Women who are pregnant or breastfeeding.
- History of recurrent infections requiring hospitalisation and intravenous antibiotics (e.g. 3 or more episodes of the same type of infection in the past 1 year).
- Active infection requiring systemic treatment, such as infectious pneumonia, tuberculosis, etc., within 2 weeks prior to clearance.
- Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B Virus (HBV) DNA test positive
- Have received a live attenuated vaccine within 4 weeks prior to clearance or plan to receive a live attenuated vaccine during the course of the study.
- Have received high-dose corticosteroids (prednisone ≥ 60 mg/day or equivalent) within 4 weeks prior to clearance, or are unable to taper prednisone to ≤ 10 mg/day 5 days prior to clearance.
- Inability to taper or elute background therapy prior to clearing chemotherapy as described in Table 3.
- Receiving renal replacement therapy within 3 months prior to screening or anticipating the need for renal replacement therapy during the study.
- History of drug or alcohol abuse within 1 year prior to screening.
- History or evidence of suicidal thoughts within 6 months prior to screening or any suicidal behaviour within the previous 12 months that the investigator considers to be a significant risk of suicide.
- Use of another study drug within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
- History of hypersensitivity or life-threatening reaction to the study drug or any component or preparation of the study treatment (including clear chemotherapy).
- Any condition that, in the opinion of the investigator, may affect participation in the study, pose a safety risk to patients, or may confound the interpretation of study results.
The study team makes the final eligibility decision.
Where it is enrolling
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kunming, Yunnan, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.