Actively Recruiting
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
Led by Nanjing Immunophage Biotech Co., Ltd · Updated on 2026-01-13
36
Participants Needed
17
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years inclusive
- Weight of at least 45 kg
- Diagnosed with systemic lupus erythematosus according to 1997 ACR criteria
- Active lupus nephritis confirmed by biopsy within 1 year or during screening, classified as type III, IV, or coexisting with type V
- Screening disease activity score SLEDAI-2K of 6 points or higher
- 24-hour urinary protein to creatinine ratio over 1.0 g/g and estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m² or higher
- Baseline serum IFN-γ above upper normal limit
- Th1/Th2 ratio in peripheral blood of 4 or higher
- Stable use of oral prednisone (max 1 mg/kg/day) or allowed immunosuppressants at specified doses for required durations before enrollment
- Female participants must not be pregnant or breastfeeding
- Agreement to use effective contraception and no plans to donate sperm or eggs during study and 6 months after
- Willing and able to provide informed consent and comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Participation in other clinical trials within 3 months or currently (except no trial medication use)
- Severe active lupus nephritis with eGFR below 60 mL/min/1.73 m²
- Severe neuropsychiatric lupus including seizures, psychosis, delirium, or other major neurological symptoms
- History or diagnosis of non-lupus vasculitis or other connective tissue diseases
- Active skin diseases interfering with lupus evaluation except lupus-specific skin symptoms
- History of lymphoproliferative diseases or malignancies within 5 years except treated carcinoma in situ
- Uncontrolled antiphospholipid syndrome
- History of major organ or stem cell transplantation
- Recent major surgery or unhealed wounds within 4 weeks prior to screening
- Live or attenuated vaccine use within 8 weeks before screening or planned during trial
- Allergy to study drug or severe allergic conditions
- Significant cardiac impairments including advanced heart failure, recent myocardial infarction, prolonged QTc, or severe arrhythmias
- Active or latent tuberculosis infection
- Serious herpes virus infections
- Recent antibiotic or antiviral therapy within 2 weeks before screening
- Hospitalization for opportunistic infections within 3 months before screening
- Use of traditional Chinese medicines like Tripterygium Wilfordii within 4 weeks before screening
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV as specified
- Significant liver or kidney test abnormalities or low blood counts
- Difficulty swallowing
- History of drug addiction or abuse
- Acute illnesses before study drug use
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Fujian Provincial Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
4
Sun Yai-sen Memorial Hospital, Sun Yai-sen University
Guangzhou, Guandong, China
Actively Recruiting
5
Hebei Petro China Central Hospital
Langfang, Hebei, China
Terminated
6
Xinxiang Central Hospital
Xinxiang, Henan, China
Actively Recruiting
7
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
8
Wuhan Hospital of Traditional Chinese and Western Medicine
Wuhan, Hubei, China
Actively Recruiting
9
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
10
Nanjing DrumTower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
11
Nantong First People's Hospital
Nantong, Jiangsu, China
Actively Recruiting
12
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
13
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
14
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
15
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
16
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
17
Jinhua Municipal Centeral Hospital Medical Group
Jinhua, Zhejiang, China
Actively Recruiting
Research Team
F
Filipe Huang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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