Lupus NephritisPhase 1/2NCT06717815
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
A Phase 1/2 study testing IPG11406 in people with Lupus Nephritis, run by Nanjing Immunophage Biotech Co., Ltd at 17 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- IPG11406
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 17 sitesChina
- Study dates
- 25 Feb 2025to 8 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Criteria for Inclusion and Exclusion <Inclusion Criteria>
- Aged 18-70 years (inclusive), male or female.
- In line with the revised classification criteria of the American College of Rheumatology (ACR) 1997, adult subjects diagnosed with systemic lupus erythematosus prior to screening.
- Confirmed disease activity during screening: SLEDAI-2K score ≥6.
- The patient's 24-h urine protein-to-creatinine ratio (UPCR) is >0.5 g/g or 24-h urine protein is ≥0.5 g during the screening period, and the estimated glomerular filtration rate (eGFR) calculated using the MDRD formula is ≥60 mL/min/1.73 m^2.
- The patient's baseline blood IFN-γ level exceeded the upper limit of normal (Part B only).
- Patients with baseline peripheral blood Th1/Th2 ratio ≥14 (Part B only).
- (1) Subjects who have not received induction therapy or have not received treatment in the past 2 months are allowed to be enrolled, but other treatments for systemic lupus erythematosus and lupus nephritis (including hormones, immunosuppressants, hydroxychloroquine sulfate, and biologics) are not allowed to be added during the study and follow-up period except for the study treatment. (2) Subjects are allowed to be receiving any of the following standard treatment regimens at the time of enrollment: 1) Oral prednisone (or equivalent) monotherapy: a. Treatment duration: ≥ 2 weeks prior to screening and have a stable dose for ≥ 2 weeks prior to enrollment; b. Dose requirements: maximum daily dose: 1 mg/kg/day; 2) Immunosuppressants: a. Permitted medications include: antimalarials, azathioprine, cyclophosphamide, mycophenolate mofetil/mycophenolic acid, methotrexate, cyclosporine A, and tacrolimus; b. Treatment duration: ≥ 12 weeks prior to screening and have a stable dose for ≥ 8 weeks prior to enrollment; c. Dose requirements: hydroxychloroquine ≤ 400 mg/day, azathioprine ≤ 100 mg/day, cyclophosphamide ≤ 800 mg/4 weeks, mycophenolate mofetil/mycophenolic acid ≤ 2 g/day, oral, subcutaneous (SC), or intramuscular methotrexate ≤ 15 mg/week, cyclosporine A ≤ 3 mg/kg/day, tacrolimus ≤ 3 mg/day; 3) Oral prednisone (or equivalent) monotherapy ± hydroxychloroquine sulfate ± ≥ one immunosuppressant a. The above requirements for treatment duration and dose stability of oral corticosteroids (OCS) and immunosuppressants should be met; b. The maximum daily/weekly dose of each drug in 1) and 2) should not be exceeded.
8.Female subjects are required to be non-pregnant and non-lactating during the trial.
9.Subjects who do not have a pregnancy plan, voluntarily take effective contraceptive measures (see the Appendix for details), and have no sperm or egg donation plan from screening to 6 months after the end of the study.
The subject voluntarily participates in the study, is able to sign the informed consent form, and complies with the requirements on the informed consent form.
<Exclusion Criteria>
- Pregnant and lactating women.
- Have participated in other clinical trials within 3 months before screening and/or are currently participating in other clinical trials (except for those who have not used the investigational product).
- Active severe lupus nephritis with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2 calculated using the MDRD formula.
- Severe neuropsychiatric SLE includes, but is not limited to, the following: seizures, new or worsening impaired level of consciousness, psychosis, delirium or confusional state, aseptic meningitis, ascending or transverse myelitis, chorea, cerebellar ataxia, mononeuritis multiplex, demyelinating syndromes, or any condition that prevents the subject from fully understanding the ICF.
- History or current diagnosis of clinically significant non-SLE-associated vasculitis syndrome or overlap with other connective tissue diseases.
- Any active dermatologic disease other than SLE that may interfere with study assessments of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous lupus manifestations (eg, cutaneous vascular disease, periungual telangiectasias, sclerodactyly, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus.
- Those who have had or are currently suffering from malignant tumors in the past 5 years (except for skin squamous cell carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma, and cervical carcinoma in situ that have undergone radical treatment and do not have any evidence of recurrence).
- Patients with uncontrolled anticardiolipin antibody syndrome (APS).
- With a history of major organ transplantation (e.g., heart, lung, kidney, and liver) or hematopoietic stem cell/bone marrow transplantation.
- Major surgical procedure (craniotomy, thoracotomy, or laparotomy), or unhealed wounds, ulcers, or fractures within 4 weeks prior to screening.
- Have received a live/attenuated vaccine within 8 weeks before screening or plan to receive a live/attenuated vaccine during the trial.
- Those who are allergic to the study drugs (including excipients), suffer from severe allergic diseases, or are allergic constitution (such as allergic to two or more drugs, food, or pollen), which may cause damage to the safety of the subjects as judged by the investigator.
- Has any of the following cardiac impairment at screening: a. New York Heart Association (NYHA) Class III-IV; b. Uncontrolled angina, congestive heart failure, or myocardial infarction within 6 months prior to the first dose; c. QTcF prolongation calculated by Fridericia's formula (> 450 msec for males; > 470 msec for females); d. type II second degree atrioventricular (AV) block, third degree atrioventricular (AV) block or PR interval > 250 ms, etc.; e. various factors that may increase the risk of QTcF prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, and unexplained sudden death before 40 years of age in first-degree relatives in family history; f. Left ventricular ejection fraction (LVEF) < 50%.
- Has active or latent tuberculosis infection at screening.
- Presence of serious herpes virus infections at screening, such as herpes encephalitis, disseminated herpes, and ophthalmic herpes.
- Use of intravenous anti-infectives (including antivirals and antibiotics) for infections within 4 weeks prior to screening.
- Has been hospitalized for an opportunistic infection within 3 months prior to screening.
- Have been treated with Chinese patent medicines such as Tripterygium wilfordii within 4 weeks before screening.
- HBsAg-positive in hepatitis B panel (HBsAg-negative but HBcAb-positive, additional HBV-DNA quantitative test is required; patients with HBV-DNA test results ≥ the upper limit of reference value at each site or requiring antiviral therapy are ineligible for study participation), hepatitis C antibody-positive (additional HCV-RNA test may be performed; if negative, the patient may be enrolled), Treponema pallidum antibody-positive (if Treponema pallidum antibody is positive, a further Treponema pallidum serological test should be performed; patients who have been infected with syphilis but have been cured as judged by the investigator are eligible), and HIV antibody-positive.
- Subjects with significant abnormalities in liver and kidney functions and hematology at screening, including: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN), serum total bilirubin > 1.5 × ULN, hemoglobin < 90 g/L, white blood cell count < 3.0 × 10^9/L, platelet count (PLT) < 75 × 10^9/L, and neutrophil count < 1.0 × 10^9/L; other abnormal laboratory test results that, in the judgment of the investigator, may affect the subject's completion of the trial or interfere with the trial results.
- Dysphagia.
- have a history of drug abuse or substance abuse.
- Subjects with acute diseases prior to the use of the investigational product. Other conditions judged by the investigator to be unsuitable for enrollment.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital, Sichuan University
Chengdu, Sichuan
Fujian Medical University Union Hospital
Fuzhou, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian
Sun Yai-sen Memorial Hospital, Sun Yai-sen University
Guangzhou, Guandong
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui
Shandong Provincial Hospital
Jinan, Shandong
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang
Hebei Petro China Central Hospital
Langfang, Hebei
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Nanjing DrumTower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Nantong First People's Hospital
Nantong, Jiangsu
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Renmin Hospital of Wuhan University
Wuhan, Hubei
Wuhan Hospital of Traditional Chinese and Western Medicine
Wuhan, Hubei
Xinxiang Central Hospital
Xinxiang, Henan
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
Official title: 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
Read the 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.
This study has two parts.In Part A1, there will be 3 dose groups, 20 mg bid (Cohort 1), 40 mg bid (Cohort 2), 80 mg bid (Cohort 3).In Cohorts 1 to 3, there will be 3-6 participants in each cohort.In Part A2, dose expansion will be conducted at the proposed recommended Phase 2 dose (RP2D). All subjects will be screened within 28 days before administration, and eligible subjects will be administered and observed for 28 days after screening. In this part, it is planned to recruit about 36 patients with nephritis.
After each cohort has completed the 28-day dosing and evaluation, the safety monitoring committee (SMC) will evaluate the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available PK data. Based on the evaluation results of safety and tolerability, the SMC will decide whether to administer the next dose group.Part A1 will determine the recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD) of IPG11406.
The design of Part B will be finalized based on the results of Part A.
- Conditions
- Lupus Nephritis
- Being tested
- IPG11406
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG11406Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (20 mg, Bid) | Experimental | 3~6 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. Receives: Drug: IPG11406 |
| Cohort 2 (40 mg, Bid) | Experimental | 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, 3~6 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. Receives: Drug: IPG11406 |
| Cohort 3 (80 mg, Bid) | Experimental | 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, 3~6 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. Receives: Drug: IPG11406 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability via assessment of Adverse events
Grades of AE will be assessed according to CTCAE 5.0
Measured: Up to 58 days
Evaluate the safety and tolerability via Respiration rate of Vital Signs
Changes from baseline， Respiration rate in times per minute
Measured: Up to 58 days
Evaluate the safety and tolerability via Heart rate of Vital Signs
Changes from baseline， Heart rate in beats per minute
Measured: Up to 58 days
Evaluate the safety and tolerability via Blood pressure of Vital Signs
Changes from baseline，Blood pressure in mmHg
Measured: Up to 58 days
Evaluate the safety and tolerability via Body temperature of Vital Signs
Changes from baseline，Body temperature in Celsius degree
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 58 days
Evaluating the safety and tolerability from Laboratory Examination
Changes from baseline of Laboratory Examination (hematology, clinical chemistry, coagulation, urinalysis)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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),
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 58 days
Secondary outcomes (15)
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Maximum Plasma Concentration
PK parameters:Maximum Plasma Concentration [Cmax]
Measured: 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)
Measured: 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)
Measured: Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from T1/2
Elimination half-life (T1/2) after dose
Measured: 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
Measured: 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
Measured: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Autoantibodies
Changes in autoantibodies before and after medication administration
Measured: 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
Measured: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from cytokines
Changes in cytokines before and after medication administration
Measured: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Th1/Th2 detection
Changes in Th1/Th2 before and after medication administration
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Serum ferritin
Changes in Serum ferritin before and after medication administration
Measured: 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.
Measured: Up to 58 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start25 Feb 2025
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Immunophage Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717815
- Sponsor's protocol ID
- IPG11406-C002
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06717815
- Acronym / sponsor ID
- IPG11406-C002
- Conditions
- Lupus Nephritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nanjing Immunophage Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
This study has two parts.In Part A1, there will be 3 dose groups, 20 mg bid (Cohort 1), 40 mg bid (Cohort 2), 80 mg bid (Cohort 3).In Cohorts 1 to 3, there will be 3-6 participants in each cohort.In Part A2, dose expansion will be conducted at the proposed recommended Phase 2 dose (RP2D). All subjects will be screened within 28 days before administration, and eligible subjects will be administered and observed for 28 days after screening. In this part, it is planned to recruit about 36 patients with nephritis.
After each cohort has completed the 28-day dosing and evaluation, the safety monitoring committee (SMC) will evaluate the safety and tolerability of IPG11406 based on all accumulated safety data (including follow-up data) and available PK data. Based on the evaluation results of safety and tolerability, the SMC will decide whether to administer the next dose group.Part A1 will determine the recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD) of IPG11406.
The design of Part B will be finalized based on the results of Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (20 mg, Bid) | Experimental | Drug: IPG114063~6 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. |
| Cohort 2 (40 mg, Bid) | Experimental | Drug: IPG11406After 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, 3~6 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. |
| Cohort 3 (80 mg, Bid) | Experimental | Drug: IPG11406After 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, 3~6 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG11406Investigational 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. | Drug | Cohort 1 (20 mg, Bid), Cohort 2 (40 mg, Bid), Cohort 3 (80 mg, Bid) |
Primary outcome
Evaluate the safety and tolerability via assessment of Adverse events
Time frame: Up to 58 days
Grades of AE will be assessed according to CTCAE 5.0
Evaluate the safety and tolerability via Respiration rate of Vital Signs
Time frame: Up to 58 days
Changes from baseline， Respiration rate in times per minute
Evaluate the safety and tolerability via Heart rate of Vital Signs
Time frame: Up to 58 days
Changes from baseline， Heart rate in beats per minute
Evaluate the safety and tolerability via Blood pressure of Vital Signs
Time frame: Up to 58 days
Changes from baseline，Blood pressure in mmHg
Evaluate the safety and tolerability via Body temperature of Vital Signs
Time frame: Up to 58 days
Changes from baseline，Body temperature in Celsius degree
Evaluating the safety and tolerability from Red blood cell count of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline of Red blood cell count in whole blood is reported in the form of number.
Evaluating the safety and tolerability from White blood cell of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline of White blood cell count in whole blood is reported in the form of number.
Evaluating the safety and tolerability from lymphocyte count of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline , Lymphocyte count in whole blood is reported in the form of number.
Evaluating the safety and tolerability from hemoglobin of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline , Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Evaluating the safety and tolerability from Laboratory Examination
Time frame: Up to 58 days
Changes from baseline of Laboratory Examination (hematology, clinical chemistry, coagulation, urinalysis)
Evaluating the safety and tolerability from Prothrombin time of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Evaluating the safety and tolerability from Activated partial thromboplastin time of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.
Evaluating the safety and tolerability from total bilirubin concentration of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Evaluating the safety and tolerability from direct bilirubin concentratio of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Evaluating the safety and tolerability from ALT of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of ALT concentration (U/L) in serum will be recorded.
Evaluating the safety and tolerability from AST of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of AST concentration (U/L) in serum will be recorded.
Evaluating the safety and tolerability from creatinine concentration of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of creatinine concentration (μmol/L) in serum will be recorded.
Evaluating the safety and tolerability from triglyceridesconcentration of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of triglycerides (TG) concentration (mmol/L) in serum will be recorded.
Evaluating the safety and tolerability from urine protein of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of urine protein will be examined by qualitative test
Evaluating the safety and tolerability from urine pH value of Laboratory Examination
Time frame: Up to 58 days
Changes from baseline, Changes of urine pH value will be recorded.
Evaluating the safety and tolerability from ventricular rate of Electrocardiogram
Time frame: Up to 58 days
Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for ventricular rate (beats/min)
Evaluating the safety and tolerability from PR interval of Electrocardiogram
Time frame: Up to 58 days
Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for PR interval (ms)
Evaluating the safety and tolerability from QRS (ms) of Electrocardiogram
Time frame: Up to 58 days
Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for QRS (ms)
Evaluating the safety and tolerability from QTc of Electrocardiogram
Time frame: Up to 58 days
Changes from Clinical Significant Changes in 12-Lead Electrocardiogram (ECG) findings for QTc (ms),
Evaluate the impact of oral IPG11406 on biomarkers in patients with Lupus Nephritis
Time frame: Up to 58 days
Changes in biomarkers before and after medication administration in patients
Evaluate the impact of oral administration of IPG11406 on 24-hour urine protein quantitation of proteinuria and renal function in patients with Lupus Nephritis
Time frame: Up to 58 days
Measure the changes in 24-hour urine protein quantitation before and after medication administration
Evaluate the impact of oral administration of IPG11406 on estimated glomerular filtration rate of proteinuria and renal function in patients with Lupus Nephritis
Time frame: Up to 58 days
Measure the changes in estimated glomerular filtration rate (eGFR) calculated using the MDRD formula before and after medication administration
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
Time frame: Up to 58 days
Measure the changes in ratio of 24-hour urine protein to urine creatinine before and after medication administration
Evaluate the impact of oral administration of IPG11406 on proteinuria and renal function in patients with Lupus Nephritis
Time frame: Up to 58 days
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
15 secondary outcomes
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Maximum Plasma Concentration
Time frame: Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Area under the curve
Time frame: Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from clearance at steady state
Time frame: Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from T1/2
Time frame: Up to 28 days
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in CL by plasma concentration of whole blood sample
Time frame: Up to 28 days
Evaluate the preliminary efficacy of oral IPG11406 from peripheral blood T lymphocyte counts and proportion
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Autoantibodies
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Relative count of lymphocyte subsets
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from cytokines
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Th1/Th2 detection
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Routine immunological tests
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 in patients with Lupus Nephritis
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from 24-hour urine protein test
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Serum ferritin
Time frame: Up to 58 days
Evaluate the preliminary efficacy of oral IPG11406 from Systemic Lupus Erythematosus Disease Activity Index 2000（SLEDAI-2K） score
Time frame: Up to 58 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPG11406 in people with Lupus Nephritis, run by Nanjing Immunophage Biotech Co., Ltd at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability via assessment of Adverse events (time frame: Up to 58 days). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.