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New treatment option for Lupus Nephritis
Official title Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
ClinicalTrials.gov ID: NCT06717815
What this study is testing
What is IPG11406?
IPG11406 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for lupus nephritis.
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
- A multi-center, multi-dose phase Ib/IIa clinical study evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
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 70
You may be able to join if
- Criteria for Inclusion and Exclusion \
- The age range is between 18 and 70 years old (including 18 and 70), with no gender restrictions.
- Weight ≥ 45kg.
- Adult people who meet the revised classification criteria of the American College of Rheumatology (ACR) 1997 and were diagnosed with systemic lupus...
- During the screening period, the disease activity was confirmed as follows: SLEDAI-2K score ≥ 6 points. Accompanied by lupus nephritis (according to...
You likely can't join if
- Pregnant and lactating women.
- Screening for participation in other clinical trials within the previous 3 months and/or currently (excluding those who have not used the trial...
- Active severe lupus nephritis, with estimated glomerular filtration rate (eGFR) calculated using the MDRD formula \<60ml/min/1.73m\^2.
- Severe neuropsychiatric SLE includes but is not limited to the following: seizures, new or worsening impaired level of consciousness, psychosis...
- History or current diagnosis of clinically significant non-SLE-related vasculitis syndrome or overlap with other connective tissue diseases.
- Any active skin diseases that may interfere with the research evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic...
See the full eligibility criteria
Who can join
- Criteria for Inclusion and Exclusion \
- The age range is between 18 and 70 years old (including 18 and 70), with no gender restrictions.
- Weight ≥ 45kg.
- Adult people who meet the revised classification criteria of the American College of Rheumatology (ACR) 1997 and were diagnosed with systemic lupus erythematosus before screening.
- During the screening period, the disease activity was confirmed as follows: SLEDAI-2K score ≥ 6 points. Accompanied by lupus nephritis (according to the 2003 International Society of Nephrology/Renal Pathology Society...
- During the screening period, the patient's 24-hour urinary protein to creatinine ratio (UPCR) is greater than 1.0g/g, and the estimated glomerular filtration rate (eGFR) calculated using the MDRD formula is ≥60...
- The patient's baseline serum IFN-γ exceeded the upper limit of normal values.
- The Th1/Th2 ratio in peripheral blood of the patient during the baseline period is ≥14.
- people who have not undergone induction therapy are allowed to be enrolled, but during the study and follow-up period, they must not receive any other treatment for systemic lupus erythematosus and lupus nephritis...
- Female people must be in a non-pregnant and non-breastfeeding period during the trial.
- The people have no plans to become pregnant within 6 months after the screening and the end of the trial, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs;
- The people voluntarily participate in the study, are able to sign the informed consent form, and comply with the requirements stated on the informed consent form. \<
What rules you out
- Pregnant and lactating women.
- Screening for participation in other clinical trials within the previous 3 months and/or currently (excluding those who have not used the trial medication).
- Active severe lupus nephritis, with estimated glomerular filtration rate (eGFR) calculated using the MDRD formula \<60ml/min/1.73m\^2.
- Severe neuropsychiatric SLE includes but is not limited to the following: seizures, new or worsening impaired level of consciousness, psychosis, delirium or confusion state, aseptic meningitis, ascending or transverse...
- History or current diagnosis of clinically significant non-SLE-related vasculitis syndrome or overlap with other connective tissue diseases.
- Any active skin diseases that may interfere with the research evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin lupus manifestations (such as skin vascular...
- Those with a history of lymphoproliferative diseases, or those who have had or currently have malignant tumors within the past 5 years (except for squamous cell carcinoma in situ, basal cell carcinoma, and cervical...
- Patients with uncontrolled antiphospholipid syndrome (APS).
- History of significant organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Major surgical procedures (craniotomy, thoracotomy, or abdominal surgery) or unhealed wounds, ulcers, or fractures within 4 weeks before screening.
- Individuals who have received live/attenuated vaccine within the 8 weeks before screening or plan to receive live/attenuated vaccine during the trial period.
- Allergic to the trial medication (including excipients) or suffering from severe allergic diseases or belonging to an allergic constitution (such as being allergic to two or more drugs, foods, or pollen), which, in the...
- During screening, any of the following cardiac impairments is present: a. New York Heart Association (NYHA) functional class III to IV; b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6...
- Active or latent tuberculosis infection during screening.
- There is a serious herpes virus infection during screening, such as herpes encephalitis, disseminated herpes, and ocular herpes.
- Needs to take oral anti-infective drugs (including antiviral drugs) or intravenous antibiotics due to infection within 2 weeks before screening.
- Hospitalization due to opportunistic infections within 3 months before screening.
- Treatment with traditional Chinese patent medicines and simple preparations such as Tripterygium Wilfordii within 4 weeks before screening.
- Hepatitis B test shows HBsAg positive (if HBsAg is negative but HBcAb is positive, then HBV-DNA quantitative test is required, and patients with HBV-DNA test results ≥ the upper limit of the reference value of each...
- During screening, people with significant abnormalities in liver and kidney function tests and blood routine examination, including: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) exceeding twice...
- Those who have difficulty swallowing.
- History of drug addiction or drug abuse;
- Those who have acute diseases before using the clinical trial drugs;
- Other conditions that the investigator deem unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Guangzhou, Guandong, China
- Langfang, Hebei, China
- Xinxiang, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nantong, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Jinhua, Zhejiang, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Fuzhou, Fujian, China; Guangzhou, Guandong, China; Langfang, Hebei, China; Xinxiang, Henan, China; Wuhan, Hubei, China and 9 more location(s). 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.