Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE (Lupus)

Kangpu Biopharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: SLE; Drug

Treatments: Drug: KPG-818 high dose; Drug: Placebo; Drug: KPG-818 low dose; Drug: KPG-818 mid dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04643067

KPG-818-SLE

Details and patient eligibility

About

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

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are listed as follows:

1. Age≥18

2. BMI between 18-40kg/m²

3. Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE

4. Meeting SLE activity requirements

5. Males and females childbearing potential must agree to use contraception methods

6. All patients must:

   1. Understand that KPG-818 could have potential teratogenic risk.
   2. Agree not to share KPG-818 with another person.
   3. Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.

7. 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.

8. 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:

1. Use of any prohibited medications within the pre-specified time
2. Patients must meet exclusionary lab criteria
3. Active and/or unstable neuropsychiatric SLE
4. Active or history of severe systemic bacterial, viral, fungal, mycobacterial, or parasitic infections within 6 months prior to Screening
5. Current or recent sign or symptoms of infections, or severe viral infections
6. Conditions predisposes patient to infection
7. Active TB or positive QuantiFERON®-TB Gold test
8. Patients with malignancy and antiphospholipid syndrome history
9. Inflammatory joint or skin disease, mixed connective tissue disease, scleroderma, and/or overlap syndromes, or acute or chronic disease
10. Concomitant condition that required systemic corticosteroid use within 1 year before Screening
11. Alcohol or drug abuse history
12. Positive urine drug test at screening
13. History or planned major surgery
14. Pregnant or breastfeeding female
15. Signs or symptoms of COVID-19 infection
16. Known allergic reaction to any of the ingredients for study drug or placebo

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

KPG-818 low dose

Active Comparator group

Description:

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.

Treatment:

Drug: KPG-818 low dose

KPG-818 mid dose

Active Comparator group

Description:

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.

Treatment:

Drug: KPG-818 mid dose

KPG-818 high dose

Active Comparator group

Description:

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.

Treatment:

Drug: KPG-818 high dose

Placebo arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo