Phase IIa Study for IPG11406 in Patients With Lupus Nephritis
ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing Immunophage Biotech Co., Ltd
About this trial
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
Eligibility criteria
Qualifiers
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.)
Disqualifiers
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/1.73m².
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.
Trial design
Treatments tested in this trial
- IPG11406
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov