Phase IIa Study for IPG11406 in Patients With Lupus Nephritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: IPG11406

Detailed Description

This is a multi-center, multi-dose phase Ib/IIa study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and impact on biomarkers of IPG11406 in patients with Lupus Nephritis.

Part A Three dose groups will be administered with drugs, namely 20 mg bid (cohort 1), 40 mg bid (cohort 2), and 80 mg bid (cohort 3). In cohorts 1 to 3, there will be 9-12 subjects in each cohort. All subjects will undergo screening for 28 days before administration, and those who pass the screening will undergo 28 days of drug administration and observation. This part plans to recruit about 36 patients with Lupus Nephritis.

After each cohort completes 28 days of dosing and evaluation, the Safety Monitoring Committee (SMC) will assess the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available pharmacokinetic (PK) data under blinded conditions. Based on the results of the safety and tolerability assessment, the SMC will decide whether to proceed with dosing in the next dose cohort. Part A will determine the recommended phase II dose (RP2D) and maximum tolerated dose (MTD) of IPG11406.

Part B The design of Part B will be finalized based on the results of Part A.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Filipe Huang, Master; Phone Number: +8621 34782827; Email: yfhuang@immunophage.com.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Zongwen Shuai, MD; Phone Number: +86 13956050659; Email: lscszw0569@aliyun.com
      • Principal Investigator: Zongwen Shuai
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Provincial Hospital
      • Contact: He Lin; Phone Number: +86 13905906076; Email: linhe0086@163.com
      • Principal Investigator: He Lin
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Shunping Lin; Phone Number: +86 13365910593; Email: fzxhlsp@126.com
      • Principal Investigator: Shunping Lin
  • Guandong
    • Guangzhou, Guandong, China
      • Recruiting
      • Sun Yai-sen Memorial Hospital, Sun Yai-sen University
      • Principal Investigator: Lie Dai
      • Contact: Lie Dai, MD; Phone Number: +86 13682277618; Email: liedai2004@163.com
  • Hebei
    • Langfang, Hebei, China
      • Terminated
      • Hebei Petro China Central Hospital
  • Henan
    • Xinxiang, Henan, China
      • Recruiting
      • Xinxiang Central Hospital
      • Contact: Wenqiang Fan; Phone Number: +86 18637373010; Email: Fwq.1125@163.com
      • Principal Investigator: Wenqiang Fan
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Cheng Chen; Phone Number: +86 13628618206; Email: 13806790@qq.com
      • Principal Investigator: Cheng Chen
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Hospital Of Traditional Chinese And Western Medicine
      • Principal Investigator: Liuqing Chen
      • Contact: Huiqin Yang; Phone Number: +86 18627763830; Email: 2429310014@qq.com
      • Sub-Investigator: Huiqin Yang
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Hui Luo; Phone Number: +86 13974871326; Email: luohuihn@sina.com
      • Principal Investigator: Hui LUO
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing DrumTower Hospital of Nanjing University Medical School
      • Principal Investigator: Lingyun Sun
      • Contact: Lingyun Sun, MD; Phone Number: +86 13705186409; Email: lingyunsun2012@163.com
    • Nantong, Jiangsu, China
      • Recruiting
      • Nantong First People's Hospital
      • Contact: Xiaoxiang Chen; Phone Number: +86 13801974325; Email: xiaoxiang0721@126.com
      • Principal Investigator: Xiaoxiang Chen
    • Xuzhou, Jiangsu, China
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Dongmei Zhou; Phone Number: +86 13813283017; Email: 13813283017@163.com
      • Principal Investigator: Dongmei Zhou
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Principal Investigator: Yan Yan
      • Contact: Yan Yan; Phone Number: +86 13879190111; Email: kiddoc@163.com
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Hongsheng Sun; Phone Number: +86 15168888385; Email: sunhongsheng_shs@126.com
      • Principal Investigator: Hongsheng Sun
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Jianlin Teng; Phone Number: +86 13916224561; Email: tengteng8151@sina.com
      • Principal Investigator: Jialin Teng
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital, Sichuan University
      • Contact: Qibing Xie; Phone Number: +86 13808175616; Email: xieqibing1971@163.com
      • Principal Investigator: Qibing Xie
  • Zhejiang
    • Jinhua, Zhejiang, China
      • Recruiting
      • Jinhua Municipal Centeral Hospital Medical Group
      • Contact: Li Hua; Phone Number: +86 13758992315; Email: 49124571@qq.com
      • Principal Investigator: Li Hua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Criteria for Inclusion and Exclusion <Inclusion Criteria>

1. The age range is between 18 and 70 years old (including 18 and 70), with no gender restrictions.
2. Weight ≥ 45kg.
3. Adult subjects who meet the revised classification criteria of the American College of Rheumatology (ACR) 1997 and were diagnosed with systemic lupus erythematosus before screening.
4. 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 (ISN/RPS) classification criteria, there is active, biopsy-confirmed type III or type IV proliferative lupus nephritis, with coexistence of type V allowed; the biopsy must be performed within 1 year before the screening visit or during the screening period, and the biopsy report is used to confirm patient eligibility.)
5. 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 mL/min/1.73 m^2; and the 24-hour urinary protein is ≥1g.
6. The patient's baseline serum IFN-γ exceeded the upper limit of normal values.
7. The Th1/Th2 ratio in peripheral blood of the patient during the baseline period is ≥14.
8. Subjects 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. Subjects are allowed to be enrolled while receiving any of the following standard treatment regimens: 1) Oral prednisone (or equivalent) monotherapy: a. Treatment duration: medication use ≥2 weeks before screening and maintaining a stable dose ≥2 weeks before enrollment; b. Dose requirements: maximum daily dose: 1mg/kg/day; 2) Immunosuppressants: a. Permissible drugs include: antimalarials, azathioprine, cyclophosphamide, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine A, tacrolimus; b. Treatment duration: medication use ≥12 weeks before screening and maintaining a stable dose ≥8 weeks before enrollment; c. Dose requirements: hydroxychloroquine ≤400mg/day, azathioprine ≤100mg/day, cyclophosphamide ≤800mg/4 weeks, mycophenolate mofetil/mycophenolic acid ≤2g/day, oral, subcutaneous (SC), or intramuscular methotrexate ≤15mg/week, Cyclosporine A ≤ 3 mg/kg/d, tacrolimus ≤ 3 mg/d; 3) Oral prednisone (or equivalent medication) monotherapy ± hydroxychloroquine sulfate ± an immunosuppressant: a. The treatment duration and dose stability requirements for Oral glucocorticoids (OCS) and immunosuppressants mentioned above must be met; b. The maximum daily/weekly dose of each drug in 1) and 2) must not be exceeded.
9. Female subjects must be in a non-pregnant and non-breastfeeding period during the trial.
10. The subjects 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;
11. The subjects voluntarily participate in the study, are able to sign the informed consent form, and comply with the requirements stated on the informed consent form.

<Exclusion Criteria>

1. Pregnant and lactating women.
2. Screening for participation in other clinical trials within the previous 3 months and/or currently (excluding those who have not used the trial medication).
3. Active severe lupus nephritis, with estimated glomerular filtration rate (eGFR) calculated using the MDRD formula <60ml/min/1.73m^2.
4. 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 myelitis, chorea, cerebellar ataxia, multiple mononeuropathy, demyelinating syndrome, or situations that make the subject unable to fully understand the ICF.
5. History or current diagnosis of clinically significant non-SLE-related vasculitis syndrome or overlap with other connective tissue diseases.
6. 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 disease, perifollicular telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus, except for SLE.
7. 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 carcinoma in situ, which have been thoroughly treated and show no evidence of recurrence).
8. Patients with uncontrolled antiphospholipid syndrome (APS).
9. History of significant organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
10. Major surgical procedures (craniotomy, thoracotomy, or abdominal surgery) or unhealed wounds, ulcers, or fractures within 4 weeks before screening.
11. Individuals who have received live/attenuated vaccine within the 8 weeks before screening or plan to receive live/attenuated vaccine during the trial period.
12. 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 judgment of the researcher, may compromise the safety of the subject.
13. 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 months prior to the first dose of medication; c. Prolonged QTcF interval calculated using the Fridericia formula (male > 450 msec; female > 470 msec); d. Second-degree type II atrioventricular (AV) block, third-degree AV block, or PR interval >250 msec; e. Various factors that may increase the risk of QTcF prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, or a family history of sudden unexplained death of a first-degree relative before the age of 40; f. Left ventricular ejection fraction (LVEF) < 50%;
14. Active or latent tuberculosis infection during screening.
15. There is a serious herpes virus infection during screening, such as herpes encephalitis, disseminated herpes, and ocular herpes.
16. Needs to take oral anti-infective drugs (including antiviral drugs) or intravenous antibiotics due to infection within 2 weeks before screening.
17. Hospitalization due to opportunistic infections within 3 months before screening.
18. Treatment with traditional Chinese patent medicines and simple preparations such as Tripterygium Wilfordii within 4 weeks before screening.
19. 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 center or requiring antiviral treatment do not meet the conditions to participate in the study), hepatitis C antibody positive (HCV-RNA test can be added, if negative, the patient can be included), Treponema pallidum antibody positive (if Treponema pallidum antibody is positive, further Treponema pallidum serological tests will be conducted. Patients who have been judged by the investigator to have been infected with syphilis in the past but have been cured meet the inclusion criteria), HIV antibody test positive.
20. During screening, subjects with significant abnormalities in liver and kidney function tests and blood routine examination, including: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) exceeding twice the upper limit of normal values, total serum bilirubin exceeding 1.5 times the upper limit of normal values; serum creatinine greater than 1.5 times the upper limit of normal values; hemoglobin <90g/L; white blood cell count <3.0×10^9/L, platelet count (PLT) <75×10^9/L; neutrophil count <1.0×10^9/L; other laboratory test results that may affect the subject's ability to complete the trial or interfere with the trial results as judged by the investigator.
21. Those who have difficulty swallowing.
22. History of drug addiction or drug abuse;
23. Those who have acute diseases before using the clinical trial drugs;
24. Other conditions that the investigator deem unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (20 mg, Bid); 9~12 subjects will be orally administered with IPD11406 20 mg twice a day. All subjects will undergo screening for 28 days before administration, and those who pass the screening will undergo 28 days of drug administration and observation.	Drug: IPG11406; Investigational Medical Products: IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 tablets are orally administered twice a Day with an interval of 12±1 hours. Tablets should not be chewed or crushed.
Experimental: Cohort 2 (40 mg, Bid); After cohort 1 complete 28 days of dosing and evaluation, the Safety Monitoring Committee (SMC) will assess the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available pharmacokinetic (PK) data. Based on SMC approval, 9~12 subjects will be orally administered 40 mg with IPD11406 twice a day. All subjects will undergo screening for 28 days before administration, and those who pass the screening will undergo 28 days of drug administration and observation.	Drug: IPG11406; Investigational Medical Products: IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 tablets are orally administered twice a Day with an interval of 12±1 hours. Tablets should not be chewed or crushed.
Experimental: Cohort 3 (80 mg, Bid); After cohort 2 complete 28 days of dosing and evaluation, the Safety Monitoring Committee (SMC) will assess the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available pharmacokinetic (PK) data. Based on SMC approval, 9~12 subjects will be orally administered 80 mg with IPD11406 twice a day. All subjects will undergo screening for 28 days before administration, and those who pass the screening will undergo 28 days of drug administration and observation.	Drug: IPG11406; Investigational Medical Products: IPG11406 Activity: An antagonist of the GPR183 Dosage form: Tablet Strength: 10 mg and 40 mg Storage：15 ~ 25 °C in a tightly sealed container, protect from light Administration: In each cohort, IPG11406 tablets are orally administered twice a Day with an interval of 12±1 hours. Tablets should not be chewed or crushed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety and tolerability via assessment of Adverse events	Grades of AE will be assessed according to CTCAE 5.0	Up to 58 days
Evaluate the safety and tolerability via Respiration rate of Vital Signs	Changes from baseline， Respiration rate in times per minute	Up to 58 days
Evaluate the safety and tolerability via Heart rate of Vital Signs	Changes from baseline， Heart rate in beats per minute	Up to 58 days
Evaluate the safety and tolerability via Blood pressure of Vital Signs	Changes from baseline，Blood pressure in mmHg	Up to 58 days
Evaluate the safety and tolerability via Body temperature of Vital Signs	Changes from baseline，Body temperature in Celsius degree	Up to 58 days
Evaluating the safety and tolerability from Red blood cell count of Laboratory Examination	Changes from baseline of Red blood cell count in whole blood is reported in the form of number.	Up to 58 days
Evaluating the safety and tolerability from White blood cell of Laboratory Examination	Changes from baseline of White blood cell count in whole blood is reported in the form of number.	Up to 58 days
Evaluating the safety and tolerability from lymphocyte count of Laboratory Examination	Changes from baseline , Lymphocyte count in whole blood is reported in the form of number.	Up to 58 days
Evaluating the safety and tolerability from hemoglobin of Laboratory Examination	Changes from baseline , Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.	Up to 58 days
Evaluating the safety and tolerability from Laboratory Examination	Changes from baseline of Laboratory Examination (hematology, clinical chemistry, coagulation, urinalysis)	Up to 58 days
Evaluating the safety and tolerability from Prothrombin time of Laboratory Examination	Changes from baseline, Prothrombin time (PT) is a screening test for exogenous coagulation factors.	Up to 58 days
Evaluating the safety and tolerability from Activated partial thromboplastin time of Laboratory Examination	Changes from baseline, Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.	Up to 58 days
Evaluating the safety and tolerability from total bilirubin concentration of Laboratory Examination	Changes from baseline, Changes of total bilirubin concentration (μmol/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from direct bilirubin concentratio of Laboratory Examination	Changes from baseline, Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from ALT of Laboratory Examination	Changes from baseline, Changes of ALT concentration (U/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from AST of Laboratory Examination	Changes from baseline, Changes of AST concentration (U/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from creatinine concentration of Laboratory Examination	Changes from baseline, Changes of creatinine concentration (μmol/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from triglyceridesconcentration of Laboratory Examination	Changes from baseline, Changes of triglycerides (TG) concentration (mmol/L) in serum will be recorded.	Up to 58 days
Evaluating the safety and tolerability from urine protein of Laboratory Examination	Changes from baseline, Changes of urine protein will be examined by qualitative test	Up to 58 days
Evaluating the safety and tolerability from urine pH value of Laboratory Examination	Changes from baseline, Changes of urine pH value will be recorded.	Up to 58 days
Evaluating the safety and tolerability from ventricular rate of Electrocardiogram	Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for ventricular rate (beats/min)	Up to 58 days
Evaluating the safety and tolerability from PR interval of Electrocardiogram	Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for PR interval (ms)	Up to 58 days
Evaluating the safety and tolerability from QRS (ms) of Electrocardiogram	Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for QRS (ms)	Up to 58 days
Evaluating the safety and tolerability from QTc of Electrocardiogram	Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for QTc (ms),	Up to 58 days
Evaluate the impact of oral IPG11406 on biomarkers in patients with Lupus Nephritis	Changes in biomarkers before and after medication administration in patients	Up to 58 days
Evaluate the impact of oral administration of IPG11406 on 24-hour urine protein quantitation of proteinuria and renal function in patients with Lupus Nephritis	Measure the changes in 24-hour urine protein quantitation before and after medication administration	Up to 58 days
Evaluate the impact of oral administration of IPG11406 on estimated glomerular filtration rate of proteinuria and renal function in patients with Lupus Nephritis	Measure the changes in estimated glomerular filtration rate (eGFR) calculated using the MDRD formula before and after medication administration	Up to 58 days
Evaluate the impact of oral administration of IPG11406 on ratio of 24-hour urine protein to urine creatinine of proteinuria and renal function in patients with Lupus Nephritis	Measure the changes in ratio of 24-hour urine protein to urine creatinine before and after medication administration	Up to 58 days
Evaluate the impact of oral administration of IPG11406 on proteinuria and renal function in patients with Lupus Nephritis	Measure the changes in 24-hour urine protein quantitation, estimated glomerular filtration rate (eGFR) calculated using the MDRD formula, and the ratio of 24-hour urine protein to urine creatinine before and after medication administration	Up to 58 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Maximum Plasma Concentration	PK parameters:Maximum Plasma Concentration [Cmax]	Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Area under the curve	PK parameters (under food effect): Area Under The Curve (AUC)	Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from clearance at steady state	PK parameters (under food effect): clearance at steady state (CLss/F)	Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from T1/2	Elimination half-life (T1/2) after dose	Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in CL by plasma concentration of whole blood sample	Clearance (CL) after dose	Up to 28 days
Evaluate the preliminary efficacy of oral IPG11406 from peripheral blood T lymphocyte counts and proportion	Changes in peripheral blood T lymphocyte counts and proportions before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Autoantibodies	Changes in autoantibodies before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Relative count of lymphocyte subsets	Changes in Relative count of lymphocyte subsets before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from cytokines	Changes in cytokines before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Th1/Th2 detection	Changes in Th1/Th2 before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Routine immunological tests	Changes in Routine immunological tests before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 in patients with Lupus Nephritis	Changes in peripheral blood B lymphocyte and T lymphocyte counts and proportions, serum albumin, blood creatinine, blood uric acid, blood urea nitrogen (BUN), white blood cells, blood neutrophils, C-reactive protein, complement C3, complement C4, immunoglobulins (IgG, IgA, IgM, IgE), anti-ds-DNA antibody, anti-nuclear antibody, anti-cardiolipin antibody (A/G/M, IgG, IgM), anti-histone antibody, anti-nucleosome antibody, anti-ribosomal P protein antibody, anti-sm antibody, anti-SSA antibody, IL-6, IL-17, IL-2, IL-1β, IL-10, IFN-α, TNF-α, ferritin, and SLEDAI-2K score before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from tests from antiphospholipid antibodies	Changes in tests for antiphospholipid antibodies before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from 24-hour urine protein test	Changes in 24-hour urine protein test before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Serum ferritin	Changes in Serum ferritin before and after medication administration	Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Systemic Lupus Erythematosus Disease Activity Index 2000（SLEDAI-2K） score	Changes in SLEDAI-2K score before and after medication administration。 Minimum and Maximum Values: The SLEDAI-2K score ranges from 0 (indicating no disease activity) to a maximum possible score that depends on the specific items being scored. However, in practical clinical use, the maximum score is typically much lower than the theoretical maximum, as not all items will be positive in any given patient. The exact maximum score can vary slightly depending on the specific version of the SLEDAI-2K being used, but it is generally well below 100. In the SLEDAI-2K, higher scores indicate a worse outcome. This is because the scale assigns points based on the presence and severity of various lupus manifestations, such as arthritis, rash, fever, and organ involvement. Therefore, as the score increases, it reflects greater disease activity and potentially more severe disease manifestations.	Up to 58 days

Collaborators and Investigators

• Sponsor: Nanjing Immunophage Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): April 22, 2026
• Study Completion (Estimated): April 22, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 30, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Skin and Connective Tissue Diseases; Lupus Nephritis
• Other Study ID Numbers: IPG11406-C002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No