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Study Title
A phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of KPG-818 in patients with mild to moderate systemic lupus erythematosus
This is a Phase 1b/2a multicenter study to evaluate the safety, PK, PD, and clinical efficacy of KPG-818 in patients with SLE. The trial will consist of 2 parts: Phase 1b, a multiple-ascending dose (MAD) study; and Phase 2a, a proof of concept (POC) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KPG-818 low dose | Active Comparator | After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks. |
|
| KPG-818 mid dose | Active Comparator | After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks. |
|
| KPG-818 high dose | Active Comparator | After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KPG-818 low dose | Drug | The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment by the occurrence of adverse events (AEs) | To calculate the occurrence rate of adverse events (AEs) | 4 weeks for phase Ib and 16 weeks for phase IIa |
| Safety assessment by the changes from baseline in laboratory parameters | To calculate the occurrence rate of out of normal ranges of laboratory parameter changes from baseline. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| Safety assessment by out of normal range of vital signs | To calculate the occurrence rate of out of normal range of vital signs from baseline. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| Safety assessment by out of normal range of ECG results | To calculate the occurrence rate of out of normal range of ECG results. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of time to peak (Tmax) for KPG-818 and KPG-818H (if applicable). | This will be measured on Day 1 after dose administration and after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of peak plasma concentration (Cmax) for KPG-818 and KPG-818H (if applicable). | This will be measured on Day 1 after dose administration. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of elimination half-life (t1/2) for KPG-818 and KPG-818H (if applicable). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in PGA (Physician Global Assessment) score at Week 12. | Mean change from baseline in PGA (Physician Global Assessment) score at Week 12. Note: the PGA is a visual scale for the physician to mark, from 0mm to 100mm, with 0mm being no disease activity and 100mm being the extreme disease activity. | 16 weeks for phase IIa |
| Measure | Description | Time Frame |
|---|---|---|
| Explore the mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B Cells at Week 2. | Explore the mean change from baseline in potential biomarker of Aiolos of KPG-818 in PBMCs and CD19+ B Cells at Week 2. | 2 weeks for phase Ib |
| Explore the mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B Cells at Week 2. |
Inclusion criteria are listed as follows:
Age≥18
BMI between 18-40kg/m²
Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE
Meeting SLE activity requirements
Males and females childbearing potential must agree to use contraception methods
All patients must:
Patients must agree not to donate blood (or any component of blood) from 3 months before Screening until 3 months after the last dose of KPG-818.
Patients must be willing to comply with precautions to reduce the risk of COVID-19 infection and to undergo COVID-19 PCR test.
Exclusion criteria are listed as follows:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Kangpu Biopharmaceuticals, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston Medical Clinic | Anniston | Alabama | 36207 | United States | ||
| University of Alabama - Birmingham |
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|
| Placebo arm | Placebo Comparator | After providing informed consent, patients will be assessed for study eligibility at the Screening visit. A total of 8 to 12 patients will be randomized to receive this dose level of KPG-818 in a double-blind fashion. Patients will receive treatment for 12 weeks with a 4-week safety follow-up. Capsules of this level of dosage will be taken orally in the morning once a day. All patients will return for follow-up visits after their final dose. The total duration of study participation for each patient (from Screening through Follow-up visit) is anticipated to be approximately 20 weeks. |
|
| KPG-818 mid dose | Drug | The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study. |
|
| KPG-818 high dose | Drug | The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study. |
|
| Placebo | Drug | This is the comparative arm. |
|
This will be measured on Day 1 after dose administration and after the plasma concentration reaches a steady state. |
| 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the area under the concentration-time curve (AUC0-24h) for KPG-818 and KPG-818H (if applicable). | This will be measured on Day 1 after dose administration. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the mean retention time (MRT) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of trough concentrations at steady state (Css_min) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of peak concentrations at steady state (Css_max) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the area under the concentration-time curve at steady state (AUCτ, AUC0-∞) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the clearance (CL/F) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the apparent volume of distribution ((Vz/F) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| PK profile of the cumulative coefficient (R) for KPG-818 and KPG-818H (if applicable). | This will be measured after the plasma concentration reaches a steady state. | 4 weeks for phase Ib and 16 weeks for phase IIa |
| Assess the proportion of patients with improvement of clinical scores of SELENA-SLEDAI (safety of estrogens in lupus national assessment-systemic lupus erythematosus disease activity index) improvement ≥ 4 points from baseline at Week 12. | To calculate the proportion of patients with SELENA-SLEDAI (safety of estrogens in lupus national assessment-systemic lupus erythematosus disease activity index) improvement ≥ 4 points from baseline at Week 12. Note: the SELENA-SLEDAI scale ranges from 0~105, with 105 as the highest disease activity. | 16 weeks for phase IIa |
| The proportion of patients with a ≥ 50% reduction from baseline in CLASI (Cutaneous Lupus erythematosus disease Area and Severity Index) activity score at Week 12, in patients with baseline CLASI activity score ≥ 10. | The proportion of patients with a ≥ 50% reduction from baseline in CLASI (Cutaneous Lupus erythematosus disease Area and Severity Index) activity score at Week 12, in patients with baseline CLASI activity score ≥ 10. Note: the total CLASI score ranges from 0 to 114, with 0 being the least disease activity and 114 being the most. | 16 weeks for phase IIa |
| Number of patients with adverse event at Week 12 | Number of patients with adverse event at Week 12 | 12 weeks for phase IIa |
| Number of patients with adverse event at Week 16. | Number of patients with adverse event at Week 16. | 16 weeks for phase IIa |
| The PK endpoint of the measurement of area under the curve (AUC) at Week 12 (AUC0-last) for assessment of KPG-818 and KPG-818H (if applicable). | The PK endpoint of the measurement of area under the curve (AUC) at Week 12 (AUC0-last) for assessment of KPG-818 and KPG-818H (if applicable). | 12 weeks for phase IIa |
| The PK endpoint of the maximum observed concentration (Cmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable) | The PK endpoint of the maximum observed concentration (Cmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable) | 12 weeks for phase IIa |
| The PK endpoint of time to Cmax (tmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable) | The PK endpoint of time to Cmax (tmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable). | 12 weeks for phase IIa |
| The PK endpoint of Ctrough throughout the dosing period for assessment of KPG-818 and KPG-818H (if applicable) | The PK endpoint of Ctrough throughout the dosing period for assessment of KPG-818 and KPG-818H (if applicable) | 12 weeks for phase IIa |
| The PK endpoint of serum concentrations by scheduled timepoints for assessment of KPG-818 and KPG-818H (if applicable) | The PK endpoint of serum concentrations by scheduled timepoints for assessment of KPG-818 and KPG-818H (if applicable) | 12 weeks for phase IIa |
Explore the mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B Cells at Week 2. |
| 2 weeks for phase Ib |
| Explore the mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B Cells at Week 2. | Explore the mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B Cells at Week 2. | 2 weeks for phase Ib |
| Mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B cells at week 12 | Mean change from baseline in potential biomarker, i.e. CRBN proteins, of KPG-818 in PBMCs and CD19+ B cells at week 12 | 12 weeks for phase IIa |
| Mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B cells at week 12 | Mean change from baseline in potential biomarker, i.e. Aiolos, of KPG-818 in PBMCs and CD19+ B cells at week 12 | 12 weeks for phase IIa |
| Mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B cells at week 12 | Mean change from baseline in potential biomarker, i.e. Ikaros, of KPG-818 in PBMCs and CD19+ B cells at week 12 | 12 weeks for phase IIa |
| Mean change from baseline in absolute counts of CD 19+ B cell and CD3+ T cell at week 12 | Mean change from baseline in absolute counts of CD 19+ B cell and CD3+ T cell at week 12 | 12 weeks for phase IIa |
| Mean change from baseline in IgA, IgG and IgM in serum at week 12 | Mean change from baseline in IgA, IgG and IgM in serum at week 12 | 12 weeks for phase IIa |
| Dose regimens for a Phase 2b/phase 3 study | Dose regimens for a Phase 2b/phase 3 study | 4 weeks for phase Ib and 16 weeks for phase IIa |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Hope Clinical Trials, Inc. | Coral Gables | Florida | 33134 | United States |
| JY Research Institute Inc | Cutler Bay | Florida | 33189 | United States |
| OSIS Clinical Research | Hollywood | Florida | 33020 | United States |
| SouthCoast Research Center Inc | Miami | Florida | 33136 | United States |
| D & H National Research Centers | Miami | Florida | 33155 | United States |
| Charisma Medical and Research Center | Miami Lakes | Florida | 33014 | United States |
| San Marcus Research Clinic | Miami Lakes | Florida | 33014 | United States |
| Omega Research MetroWest LLC | Orlando | Florida | 32808 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| Oracle Clinical Research | College Park | Georgia | 30329 | United States |
| STAT Research | Vandalia | Ohio | 54377 | United States |
| Shelby Research LLC | Memphis | Tennessee | 38119 | United States |
| Accurate Clinical Management | Houston | Texas | 77084 | United States |
| Accurate Clinical Research LLC | Houston | Texas | 77089 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2026 |
| ID | Term |
|---|---|
| C000730515 | drug-induced lupus |
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