Phase IIa Study for IPG11406 in Patients With Lupus Nephritis

NCT06717815 | Completed Phase 1 FDA Drug

• 1 other identifier: IPG11406-C002
• Study Type: interventional
• Target: 24
• 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 (15)

• 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

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.

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.

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.

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:

• 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.
• Female subjects are required to be non-pregnant and non-lactating during the trial.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Immunophage Biotech Co., Ltd: lead

Study Sites (17)

The First Affiliated Hospital Of Anhui Medical University

Hefei, Anhui, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, China

Location

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

Guangzhou, Guandong, China

Location

Hebei Petro China Central Hospital

Langfang, Hebei, China

Location

Xinxiang Central Hospital

Xinxiang, Henan, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Wuhan Hospital of Traditional Chinese and Western Medicine

Wuhan, Hubei, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Nanjing DrumTower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Nantong First People's Hospital

Nantong, Jiangsu, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Jinhua Municipal Centeral Hospital Medical Group

Jinhua, Zhejiang, China

Location

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

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: June 8, 2026
• Study Completion: June 8, 2026
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)