0.15mg KPG-818 dose for Systemic Lupus Erythematosus (SLE)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Omega Research MetroWest LLC, Orlando, FLSystemic Lupus Erythematosus (SLE)0.6mg KPG-818 dose - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is 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.

Eligible Conditions
  • Systemic Lupus Erythematosus (SLE)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
SAR439459
1
CSL300 (Phase 3)
1
BIIB059

Study Objectives

16 Primary · 9 Secondary · Reporting Duration: 4 weeks for phase Ib and 16 weeks for phase IIa

Week 12
Mean change from baseline in IgA, IgG and IgM in serum at week 12
Mean change from baseline in absolute counts of CD 19+ B cell and CD3+ T cell 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
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. Ikaros, of KPG-818 in PBMCs and CD19+ B cells at week 12
Number of patients with adverse event at Week 12
The PK endpoint of Ctrough throughout the dosing period 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)
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 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 time to Cmax (tmax) at Week 12 for assessment of KPG-818 and KPG-818H (if applicable)
Week 16
Estrogens
Mean change from baseline in PGA (Physician Global Assessment) score at Week 12.
Number of patients with adverse event at Week 16.
Lupus Erythematosus, Cutaneous
Week 2
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, 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. Ikaros, of KPG-818 in PBMCs and CD19+ B Cells at Week 2.
Week 16
Dose regimens for a Phase 2b/phase 3 study
PK profile of elimination half-life (t1/2) for KPG-818 and KPG-818H (if applicable).
Pyruvate Kinase
PK profile of peak plasma concentration (Cmax) for KPG-818 and KPG-818H (if applicable).
PK profile of the apparent volume of distribution ((Vz/F) for KPG-818 and KPG-818H (if applicable).
PK profile of the area under the concentration-time curve (AUC0-24h) for KPG-818 and KPG-818H (if applicable).
PK profile of the area under the concentration-time curve at steady state (AUCτ, AUC0-∞) for KPG-818 and KPG-818H (if applicable).
PK profile of the clearance (CL/F) for KPG-818 and KPG-818H (if applicable).
PK profile of the cumulative coefficient (R) for KPG-818 and KPG-818H (if applicable).
PK profile of the mean retention time (MRT) for KPG-818 and KPG-818H (if applicable).
PK profile of time to peak (Tmax) for KPG-818 and KPG-818H (if applicable).
Pyruvate Kinase
Safety assessment by out of normal range of ECG results
Safety assessment by out of normal range of vital signs
Safety assessment by the changes from baseline in laboratory parameters
Safety assessment by the occurrence of adverse events (AEs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
SAR439459
2
CSL300 (Phase 3)
2
BIIB059

Trial Design

4 Treatment Groups

0.15mg KPG-818 dose
1 of 4
2mg KPG-818 dose
1 of 4
0.6mg KPG-818 dose
1 of 4
Placebo arm
1 of 4

Active Control

Non-Treatment Group

60 Total Participants · 4 Treatment Groups

Primary Treatment: 0.15mg KPG-818 dose · Has Placebo Group · Phase 1 & 2

0.15mg KPG-818 dose
Drug
ActiveComparator Group · 1 Intervention: 0.15mg KPG-818 dose · Intervention Types: Drug
Placebo arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
2mg KPG-818 dose
Drug
ActiveComparator Group · 1 Intervention: 2mg KPG-818 dose · Intervention Types: Drug
0.6mg KPG-818 dose
Drug
ActiveComparator Group · 1 Intervention: 0.6mg KPG-818 dose · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks for phase ib and 16 weeks for phase iia

Who is running the clinical trial?

Kangpu Biopharmaceuticals, Ltd.Lead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Systemic Lupus Erythematosus (SLE)
40 Patients Enrolled for Systemic Lupus Erythematosus (SLE)
Kai Wei, MDStudy DirectorKangpu Biopharmaceuticals, Ltd.
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older and have agreed to sign the informed consent form.
You have a positive ANA test with a titer of 1:80 or higher.
You have high levels of anti-Smith antibodies.
If you are a woman of childbearing potential (able to get pregnant), you need to take two blood pregnancy tests and one urine pregnancy test before starting the study treatment. You also need to agree to continue taking pregnancy tests throughout the study and after the treatment ends, even if you are not sexually active.
You must have a body mass index (BMI) between 18 and 40 kg/m2.
You are able and willing to attend all scheduled visits and follow the study's rules.
You have a condition called SLE that has been diagnosed by doctors using specific criteria.
You can participate in the study even if you have SLE, but only if your disease is stable and you will not need to change or increase your treatment during the study. If you are already receiving standard care for SLE and it meets certain requirements, you may be eligible for the study.
To participate in the study, you must have active Systemic Lupus Erythematosus (SLE) with a score of six or more on the SLE Disease Activity Index. You must also be receiving stable treatment with oral corticosteroids, anti-malarial, or immunosuppressant medication. Certain neurological symptoms will not be counted towards the study entry criteria.
You have high levels of a type of antibody called anti-dsDNA.
References

Frequently Asked Questions

How many individuals are participating in this investigation?

"Kangpu Biopharmaceuticals, Ltd. is spearheading this trial and require a total of 60 qualified participants to conduct the study. It will be conducted in different locations such as Shelby Research LLC in Memphis, Tennessee and Altoona Center for Clinical Research in Duncansville, Pennsylvania." - Anonymous Online Contributor

Unverified Answer

Is this clinical study open to enrolling new participants?

"Affirmative. Data available on clinicaltrials.gov attests to the fact that this medical trial, which was initially posted on June 3rd 2021, is actively recruiting patients. Around 60 individuals are required from 5 different sites for this experiment." - Anonymous Online Contributor

Unverified Answer

How far-reaching is the current deployment of this trial?

"5 clinical centres are offering this trial to patients, including Shelby Research LLC in Memphis and SouthCoast Research Center Inc. in Miami; additionally there are 3 other medical sites hosting the study." - Anonymous Online Contributor

Unverified Answer

What objectives has this experiment been designed to fulfill?

"This clinical trial will have a primary objective of identifying the peak concentrations at steady state (Css_max) for KPG-818 and its variant, KPG-818H, over an interval lasting 4 weeks in phase Ib and 16 weeks in phase IIa. Secondary endpoints include tracking changes from baseline Physician Global Assessment scores after 12 weeks as well as area under the curve (AUC0-last) values to measure potency and Ctrough levels throughout the dosing period." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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