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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
IPG11406
DrugInvestigational 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.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Cohort 1 (20 mg, Bid)Experimental treatment 1 intervention
Group B: Cohort 2 (40 mg, Bid)Experimental treatment 1 intervention
Group C: Cohort 3 (80 mg, Bid)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability via assessment of Adverse events
Grades of AE will be assessed according to CTCAE 5.0
Time frame
Up to 58 days2
Evaluate the safety and tolerability via Respiration rate of Vital Signs
Changes from baseline， Respiration rate in times per minute
Time frame
Up to 58 days3
Evaluate the safety and tolerability via Heart rate of Vital Signs
Changes from baseline， Heart rate in beats per minute
Time frame
Up to 58 days4
Evaluate the safety and tolerability via Blood pressure of Vital Signs
Changes from baseline，Blood pressure in mmHg
Time frame
Up to 58 daysSecondary outcomes
1
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Maximum Plasma Concentration
PK parameters:Maximum Plasma Concentration \[Cmax\]
Time frame
Up to 28 days2
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 in Area under the curve
PK parameters (under food effect): Area Under The Curve (AUC)
Time frame
Up to 28 days3
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from clearance at steady state
PK parameters (under food effect): clearance at steady state (CLss/F)
Time frame
Up to 28 days4
Evaluate the pharmacokinetics (PK) characteristics of oral IPG11406 from T1/2
Elimination half-life (T1/2) after dose
Time frame
Up to 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov