Phase IIa Study for IPG11406 in Patients With Lupus Nephritis

NCT06717815 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IPG11406-C002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 17

Brief 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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (29)

• 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 Outcomes (16)

• Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Maximum Plasma Concentration

  Up to 28 days

• Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Area under the curve

  Up to 28 days

• Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from clearance at steady state

  Up to 28 days

• Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from T1/2

  Up to 28 days

• Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in CL by plasma concentration of whole blood sample

  Up to 28 days

Study Arms (3)

Cohort 1 (20 mg, Bid)

EXPERIMENTAL

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

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, 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

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, 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

Interventions

IPG11406 DRUG

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.

Cohort 1 (20 mg, Bid); Cohort 2 (40 mg, Bid); Cohort 3 (80 mg, Bid)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age range is between 18 and 70 years old (including 18 and 70), with no gender restrictions.
• Weight ≥ 45kg.
• 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.
• 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.)
• 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.
• 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.
• 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.
• Female subjects must be in a non-pregnant and non-breastfeeding period during the trial.
• 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;
• 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.

You may not qualify 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 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 myelitis, chorea, cerebellar ataxia, multiple mononeuropathy, demyelinating syndrome, or situations that make the subject unable to fully understand the ICF.
• 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 disease, perifollicular telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus, except for SLE.
• 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).
• 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 judgment of the researcher, may compromise the safety of the subject.
• 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%;
• 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.

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (17)

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Sun Yai-sen Memorial Hospital, Sun Yai-sen University

Guangzhou, Guandong, China

RECRUITING

Hebei Petro China Central Hospital

Langfang, Hebei, China

TERMINATED

Xinxiang Central Hospital

Xinxiang, Henan, China

RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Wuhan Hospital of Traditional Chinese and Western Medicine

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Nanjing DrumTower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Nantong First People's Hospital

Nantong, Jiangsu, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Jinhua Municipal Centeral Hospital Medical Group

Jinhua, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Filipe Huang, Master

CONTACT

+8621 34782827; yfhuang@immunophage.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: February 25, 2025
• Primary Completion: April 22, 2026
• Study Completion: April 22, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)