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New treatment option for Systemic Lupus Erythematosus
Official title A Study of SHR-2173 in Participants With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07299422
What this study is testing
What is SHR-2173 Injection?
SHR-2173 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for systemic lupus erythematosus.
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
- This study is a randomized, double-blind, multi-center, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in adult participants with active Systemic Lupus Erythematosus (SLE), including a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and a 12-week safety follow-up period. Approximately 245 SLE patients will be included.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and female participants aged 18 through 65 years (including boundary value)at the time of screening.
- The Body Mass Index (BMI) ≥18 kg/m ² at the time of screening.
- Diagnosed with SLE for at least 6 months prior to screening.
- ANA≥1:80, or anti-dsDNA antibodies and/or anti-Sm antibodies above the upper limit of the normal range as determined by a central laboratory at the...
- High disease activity at screening and at baseline.
You likely can't join if
- The presence of any of the following medical histories or comorbidities: a) Severe lupus-related kidney disease and/or kidney damage; b) Active...
- Use any of the following medications /treatments or participate in a clinical trial: a) Previously received gene therapy such as CAR-T or T-cell...
- The presence of the following tumor risks or accompanied by other poorly controlled serious or chronic diseases: a) Suffering from malignant tumors...
- Infection-related medical history and examinations: a) Herpes zoster infection meets one of the following conditions: 1) A history of systemic herpes...
- General situation: a) Pregnant or lactating women; b) Having a history of alcohol abuse or illegal drug abuse within one year prior to screening; c)...
See the full eligibility criteria
- Male and female participants aged 18 through 65 years (including boundary value)at the time of screening.
- The Body Mass Index (BMI) ≥18 kg/m ² at the time of screening.
- Diagnosed with SLE for at least 6 months prior to screening.
- ANA≥1:80, or anti-dsDNA antibodies and/or anti-Sm antibodies above the upper limit of the normal range as determined by a central laboratory at the time of screening.
- High disease activity at screening and at baseline.
- Currently receiving at least one or more of the following standard therapies for SLE at stable doses: oral corticosteroids (OCS), antimalarial drugs, and conventional immunosuppressants.
- Participants thoroughly understand the content, process and possible adverse reactions before the trial, and voluntarily sign the written informed Consent Form (ICF).
- Female people with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to...
- The presence of any of the following medical histories or comorbidities: a) Severe lupus-related kidney disease and/or kidney damage; b) Active neuropsychiatric SLE occurred 6 months prior to screening; c) Autoimmune...
- Use any of the following medications /treatments or participate in a clinical trial: a) Previously received gene therapy such as CAR-T or T-cell Engager (TCE) ; b) Received anti-CD20 monoclonal antibody within 6 months...
- The presence of the following tumor risks or accompanied by other poorly controlled serious or chronic diseases: a) Suffering from malignant tumors or having a history of malignant tumors; b) Accompanying other poorly...
- Infection-related medical history and examinations: a) Herpes zoster infection meets one of the following conditions: 1) A history of systemic herpes zoster, such as disseminated herpes zoster, herpetic encephalitis or...
- General situation: a) Pregnant or lactating women; b) Having a history of alcohol abuse or illegal drug abuse within one year prior to screening; c) Individuals with allergic constitutions, or those known to be...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, 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 - 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.