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Small Molecule
KPG-818 for Systemic Lupus Erythematosus (Lupus Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Kangpu Biopharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks for phase ib and 16 weeks for phase iia
Summary
This trial is testing a new drug called KPG-818 in patients with mild to moderate lupus. The study aims to see if the drug is safe and effective. Researchers will look at how the drug moves through the body and its impact on lupus symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks for phase ib and 16 weeks for phase iia
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks for phase ib and 16 weeks for phase iia
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Estrogens
PK profile of elimination half-life (t1/2) for KPG-818 and KPG-818H (if applicable).
Pyruvate Kinase
+13 moreSecondary study objectives
Mean change from baseline in PGA (Physician Global Assessment) score at Week 12.
Number of patients with adverse event at Week 12
Number of patients with adverse event at Week 16.
+6 moreOther study objectives
Dose regimens for a Phase 2b/phase 3 study
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.
+6 moreTrial Design
4Treatment groups
Active Control
Placebo Group
Group I: KPG-818 low doseActive Control1 Intervention
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.
Group II: KPG-818 mid doseActive Control1 Intervention
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.
Group III: KPG-818 high doseActive Control1 Intervention
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.
Group IV: Placebo armPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Kangpu Biopharmaceuticals, Ltd.Lead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
MDStudy DirectorKangpu Biopharmaceuticals, Ltd.
971 Previous Clinical Trials
939,250 Total Patients Enrolled
Kai Wei, MDStudy DirectorKangpu Biopharmaceuticals, Ltd.
1 Previous Clinical Trials
30 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 a condition called SLE that has been diagnosed by doctors using specific criteria.You are currently pregnant or breastfeeding.You must have a body mass index (BMI) between 18 and 40 kg/m2.You have high levels of a type of antibody called anti-dsDNA.You have a medical history that makes you more likely to get infections, such as a weakened immune system or missing spleen.Your body mass index (BMI) is between 18 and 40 kg/m2.You have the symptoms of SLE that fit the criteria for the study's Phase 1b and Phase 2a.You have high levels of anti-Smith antibodies.You are allergic to any of the ingredients in the study drug or placebo.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 are able and willing to attend all scheduled visits and follow the study's rules.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.You have a history of drug or alcohol abuse within the last year, as determined by the researcher.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 had cancer within the last 5 years, except for certain types of skin or cervical cancer that have been treated and have not returned.You have other inflammatory joint or skin diseases, mixed connective tissue disease, scleroderma, or overlap syndromes that are not caused by systemic lupus erythematosus (SLE).You have had signs or symptoms of infection within the last 4 weeks, except for minor infections such as a cold or stomach virus that have fully gone away. Fungal infections of the nail beds, oral or vaginal candidiasis that have been treated and resolved are also not included in this criterion.You are experiencing symptoms that may be a sign of a COVID-19 infection according to the investigator.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo arm
- Group 2: KPG-818 low dose
- Group 3: KPG-818 mid dose
- Group 4: KPG-818 high dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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