SLE; DrugPhase 1/2LupusNCT04643067

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

A Phase 1/2 study testing KPG-818 low dose in phase 1b, KPG-818 mid dose in phase 1b and KPG-818 high dose in phase 1b in people with SLE; Drug, run by Kangpu Biopharmaceuticals, Ltd. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The clinical trial is titled "A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients with Systemic Lupus Erythematosus". Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: SLE; Drug
What is being tested?: KPG-818 low dose in phase 1b, KPG-818 mid dose in phase 1b and KPG-818 high dose in phase 1b
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 18 sitesUnited States
Study dates: 3 Jun 2021to 29 Jun 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Male or female of 18 years of age or older at the time of signing the ICF.
BMI between 18 and 40 kg/m2.
Able and was willing to adhere to the visit schedule and other protocol requirements.
Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE.
Met SLE activity requirements as described below:

For the Phase 1b part of the study, patients with or without active SLE were enrolled if, in the opinion of the Investigator, the disease activity was stable and there was no need for change or increase in SLE therapy anticipated for the study duration. If patients were on stable standard care of SLE treatment, this was to comply with inclusion criteria No. 11.
For the Phase 2a part of the study, patients must have had a SLEDAI-2K score of ≥ 6 points at the screening visit with a SLEDAI-2K clinical score ≥ 4 points at the baseline visit. The "clinical" score was the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or blood laboratory results, including immunologic measures. Neurologic descriptors of the SLEDAI-2K were not counted towards the SLEDAI study entry criteria. In addition, the patient must have been on stable standard care of SLE treatment with at least 1 of the followings: OCS, anti malarial, or immunosuppressant (see inclusion criteria No. 11 for allowed medications and doses).

Documented history or presence at screening of positive autoantibodies associated with SLE, which must have included at least 1 of the following:

Positive ANA test with a titer of 1:80 or greater.
Anti-dsDNA antibodies elevated to above normal.
Anti-Smith antibody elevated to above normal.

WOCBP must:

Have had 2 negative serum pregnancy tests as verified by the Investigator prior to starting study therapy, 1 at screening and again within 3 days before taking the first dose of KPG-818, then have a negative urine pregnancy test at baseline before dosing. WOCBP must have agreed to ongoing pregnancy testing during the course of the study, and after the end of IMP. This applied even if the patient practiced true abstinence from heterosexual contact.
Either commit to true abstinence from heterosexual contact (which was reviewed on a monthly basis and source documented) or agreed to use 2 forms of reliable contraception simultaneously. One must have been a highly effective method and 1 additional effective (barrier) method and both must have been practiced without interruption, at least 28 days before starting IMP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.

Male patients must: Have practiced true abstinence or agreed to use a barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) during sexual contact with a WOCBP while participating in the study, and for at least 90 days after IMP discontinuation, even if he had undergone a successful vasectomy. Male patients had to agree not to donate semen or sperm during the treatment period and for at least 90 days after the discontinuation of KPG-818.
Female patients who were postmenopausal must have demonstrated a FSH blood level of equal to or greater than 40 mIU/mL at the screening visit. Women aged > 60 years old whose FSH values were not equal to or greater than 40 mIU/mL were included at the discretion of the Investigator and in consultation with the Sponsor.
All patients must:

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

In the Phase 2a part of the study, the patient must have been on stable standard-of-care SLE treatment with at least 1 of the followings: OCS, antimalarial, or immunosuppressant:
If was taking OCS, must be on-treatment for ≥ 4 weeks before the screening visit, and maintained on a stable dose of ≤ 20 mg/day of prednisone or equivalent for at least 4 weeks before the baseline visit.
If was taking an antimalarial agent (hydroxychloroquine, chloroquine, or quinacrine), must be on-treatment for ≥ 8 weeks before the screening visit and be on a stable dose for ≥ 4 weeks before the screening visit. Antimalarials at the following doses were allowed:

Hydroxychloroquine (≤ 400 mg/day)
Chloroquine (≤ 500 mg/day)
Quinacrine (≤ 200 mg/day)

If was taking allowed immunosuppressants, must be on-treatment for ≥ 8 weeks prior to the screening visit and be on a stable dose for ≥ 4 weeks before the screening visit. Only 1 of the immunosuppressants below was allowed at the indicated doses:

Mycophenolate mofetil (≤ 2 g/day) or mycophenolic acid (≤ 1.44 g/day)
Azathioprine (≤ 200 mg/day)
Methotrexate (≤ 20 mg/week)
Leflunomide (≤ 20 mg/day)

If was taking NSAIDs or other regularly administered analgesics, these were allowed if treatment started ≥ 4 weeks before the baseline visit and dosing had not been changed within the last 2 weeks before the baseline visit.
If immunosuppressants, antimalarial, or OCS were discontinued, the last dose must have been more than 4 weeks prior to the screening visit.
Patients had to 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 had to be willing to comply with precautions to reduce the risk of COVID 19 infection in accordance with recommendations from the applicable medical associations and the Investigator for the duration of the study and to undergo COVID 19 polymerase chain reaction test as required based on Investigator judgment and/or local requirements.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Anniston Medical Clinic
Anniston, Alabama, 36207
University of Alabama - Birmingham
Birmingham, Alabama, 35205
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Oracle Clinical Research
College Park, Georgia, 30329
Hope Clinical Trials, Inc.
Coral Gables, Florida, 33134
JY Research Institute Inc
Cutler Bay, Florida, 33189
OSIS Clinical Research
Hollywood, Florida, 33020
Accurate Clinical Management
Houston, Texas, 77084
Accurate Clinical Research LLC
Houston, Texas, 77089
Shelby Research LLC
Memphis, Tennessee, 38119
SouthCoast Research Center Inc
Miami, Florida, 33136
D & H National Research Centers
Miami, Florida, 33155
Charisma Medical and Research Center
Miami Lakes, Florida, 33014
San Marcus Research Clinic
Miami Lakes, Florida, 33014
Omega Research MetroWest LLC
Orlando, Florida, 32808
Sun Research Institute
San Antonio, Texas, 78215
Clinical Research of West Florida
Tampa, Florida, 33606
STAT Research
Vandalia, Ohio, 54377

Other trials in United States

About this study

Official title: A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus

Phase 1b: Assess safety and PK of KPG-818 in SLE patients over 14 days.
Phase 2a: Assess safety, efficacy, PD biomarkers, and PK of KPG-818 in SLE patients over 12 weeks.

The study design comprises eight Cohorts, which are outlined below:

Phase 1b dose levels: Cohort A (0.15 mg/day), B (0.6 mg/day), C (2 mg/day), and D (5 mg/day).
Phase 2a dose levels: Cohort E (0.15 mg/day), F (0.6 mg/day), G (2 mg/day) and H (placebo).

Read the detailed 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.

Conditions: SLE; Drug
Being tested: KPG-818 low dose in phase 1b, KPG-818 mid dose in phase 1b, KPG-818 high dose in phase 1b, KPG-818 ultra-high dose in phase 1b, KPG-818 low dose in phase 2a
Medical subject headings: drug-induced lupus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KPG-818 low dose in phase 1bDrug
Also called low dose in phase 1b
Patients received 0.15 mg/day of KPG-818 once daily for up to 14 days.
KPG-818 mid dose in phase 1bDrug
Also called mid dose in phase 1b
Patients received 0.6 mg/day of KPG-818 once daily for up to 14 days.
KPG-818 high dose in phase 1bDrug
Also called high dose in phase 1b
Patients received 2.0 mg/day of KPG-818 once daily for up to 14 days.
KPG-818 ultra-high dose in phase 1bDrug
Also called ultra-high dose in phase 1b
Patients received 5.0 mg/day of KPG-818 once daily for up to 14 days.
KPG-818 low dose in phase 2aDrug
Also called low dose in phase 2a
Patients received 0.15 mg/day of KPG-818 once daily for up to 84 days.
KPG-818 mid dose in phase 2aDrug
Also called mid dose in phase 2a
Patients received 0.6 mg/day of KPG-818 once daily for up to 84 days.
KPG-818 high dose in phase 2aDrug
Patients received 2.0 mg/day of KPG-818 once daily for up to 84 days.
KPG-818 Placebo in phase 2aDrug
Also called Placebo in phase 2a
Patients received KPG-818 Placebo once daily for up to 84 days.

Study groups in NCT04643067
Study group	Role	What they receive
KPG-818 low dose in Phase 1b	Active comparator	Cohort A for phase 1b (Open label). Number of patients: 6. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.15 mg/day. Frequency: once daily. Duration of treatment: 14 days. Receives: Drug: KPG-818 low dose in phase 1b
KPG-818 mid dose in Phase 1b	Active comparator	Cohort B for phase 1b (Open label) . Number of patients: 6. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.6 mg/day. Frequency: once daily. Duration of treatment: 14 days. Receives: Drug: KPG-818 mid dose in phase 1b
KPG-818 high dose in Phase 1b	Active comparator	Cohort C for phase 1b (Open label) . Number of patients: 8. Drug name: KPG-818. Dosage form: capsule. Dosage: 2.0 mg/day. Frequency: once daily. Duration of treatment: 14 days. Receives: Drug: KPG-818 high dose in phase 1b
KPG-818 ultra-high dose in Phase 1b	Active comparator	Cohort D for phase 1b (Open label) . Number of patients: 7. Drug name: KPG-818. Dosage form: capsule. Dosage: 5.0 mg/day. Frequency: once daily. Duration of treatment: 14 days. Receives: Drug: KPG-818 ultra-high dose in phase 1b
KPG-818 low dose in Phase 2a	Active comparator	Cohort E for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.15 mg/day. Frequency: once daily. Duration of treatment: 12 weeks. Receives: Drug: KPG-818 low dose in phase 2a
KPG-818 mid dose in Phase 2a	Active comparator	Cohort F for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.6 mg/day. Frequency: once daily. Duration of treatment: 12 weeks. Receives: Drug: KPG-818 mid dose in phase 2a
KPG-818 high dose in Phase 2a	Active comparator	Cohort G for phase 2a (double-blinded). Number of patients: 10. Drug name: KPG-818. Dosage form: capsule. Dosage: 2.0 mg/day. Frequency: once daily. Duration of treatment: 12 weeks. Receives: Drug: KPG-818 high dose in phase 2a
KPG-818 Placebo in Phase 2a	Placebo comparator	Cohort H for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818 placebo. Dosage form: capsule. Dosage: NA. Frequency: once daily. Duration of treatment: 12 weeks. Receives: Drug: KPG-818 Placebo in phase 2a

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety / Tolerability (Assessed by Adverse Events)
AEs were coded by the MedDRA (version 24.0 or later) and graded for severity according to CTCAE version 5.0. Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
Measured: 4 weeks for phase 1b and 16 weeks for phase 2a
Phase 1b - PK Assessment: AUC0-last of KPG-818 & KPG-818H
AUC0-last defined as the area under the plasma concentration-time curve from time 0 to the last measurable concentration, was calculated from plasma concentrations of KPG-818 using the linear-log trapezoidal method.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H
AUC0-∞ defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity, was calculated as AUClast + Clast/ λz, where Clast was the last measurable concentration.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: AUCτ of KPG-818 & KPG-818H
AUCτ defined as the area under the concentration-time curve at steady state (the area under the plasma concentration-time curve over a dosing interval). AUCτ was calculated using the linear trapezoidal method and was computed from the time of dosing to dosing time + τ (τ = 24 hours), using the estimated concentration at τ.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: Css_max of KPG-818 & KPG-818H
Css_max defined as the peak concentrations at steady state. Css_max was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: Css_min of KPG-818 & KPG-818H
Css_min defined as the trough concentrations at steady state. Css_min was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: Tmax of KPG-818 & KPG-818H
tmax defined as time to reach Cmax. If the maximum value occurs at more than 1 time point, tmax was defined as the first time point with this value. tmax was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: t1/2 of KPG-818 & KPG-818H
t1/2 defined as terminal elimination half-life. Calculated as ln(2)\ λz. KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: CL/F,ss of KPG-818 & KPG-818H
CL/F,ss defined as apparent total body clearance at steady-state. Calculated as dose/ AUCτ.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 1b - PK Assessment: Vz/F,ss of KPG-818 & KPG-818H
Vz/F,ss defined as apparent volume of distribution at steady-state. Calculated as dose/(λz × AUCτ).
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: AUC0-last of KPG-818 & KPG-818H
AUC0-last defined as the area under the plasma concentration-time curve from time 0 to the last measurable concentration, was calculated from plasma concentrations of KPG-818 using the linear-log trapezoidal method.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H
AUC0-∞ defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity, was calculated as AUClast + Clast/ λz, where Clast was the last measurable concentration.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: AUCτ of KPG-818 & KPG-818H
AUCτ defined as the area under the concentration-time curve at steady state (the area under the plasma concentration-time curve over a dosing interval). AUCτ was calculated using the linear trapezoidal method and was computed from the time of dosing to dosing time + τ (τ = 24 hours), using the estimated concentration at τ.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: Css_max of KPG-818 & KPG-818H
Css_max defined as the peak concentrations at steady state. Css_max was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: Css_min of KPG-818 & KPG-818H
Css_min defined as the trough concentrations at steady state. Css_min was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: Tmax of KPG-818 & KPG-818H
tmax defined as time to reach Cmax. If the maximum value occurs at more than 1 time point, tmax was defined as the first time point with this value. tmax was observed directly from data.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: t1/2 of KPG-818 & KPG-818H
t1/2 defined as terminal elimination half-life. Calculated as ln(2)\ λz. KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: CL/F,ss of KPG-818 & KPG-818H
CL/F,ss defined as apparent total body clearance at steady-state. Calculated as dose/ AUCτ.
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Phase 2a - PK Assessment: Vz/F,ss of KPG-818 & KPG-818H
Vz/F,ss defined as apparent volume of distribution at steady-state. Calculated as dose/(λz × AUCτ).
KPG-818H is the primary metabolite of KPG-818.
Measured: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.

Secondary outcomes (2)

Phase 2a - Mean Change From Baseline in SLEDAI-2K Score at Week 4, 8, 12, and 16
To calculate the mean SLEDAI-2K score reduced from baseline for all treatment groups in phase 2a. The SELENA-SLEDAI scale ranges from 0~105, with 105 as the highest disease activity.
Measured: At Week 4, 8, 12, and 16
Phase 2a - Mean Change From Baseline in CLASI Score at Week 4, 8, 12, 16
To calculate the mean CLASI score reduced from baseline for all treatment groups in phase 2a. The total CLASI score ranges from 0 to 114, with 0 being the least disease activity and 114 being the most
Measured: At Week 4, 8, 12, 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jun 202129 Jun 2023

First posted24 Nov 2020
Study start3 Jun 2021
Primary completion29 Jun 2023
Study completion29 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SLE; DrugStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04643067
Sponsor's protocol ID: KPG-818-SLE
Acronym: Lupus
Status last verified: Sep 2026
First submitted: 12 Nov 2020
Last updated: 29 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b/2a Multicenter Study to Assess the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of KPG-818 in Patients With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT04643067
Acronym / sponsor ID: Lupus / KPG-818-SLE
Conditions: SLE; Drug
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Kangpu Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
Study start: 3 Jun 2021 (actual)
Primary completion: 29 Jun 2023 (actual)
Study completion: 29 Jun 2023 (actual)
First posted: 24 Nov 2020 (actual)
Results: Posted 29 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 1b: Assess safety and PK of KPG-818 in SLE patients over 14 days.
Phase 2a: Assess safety, efficacy, PD biomarkers, and PK of KPG-818 in SLE patients over 12 weeks.

The study design comprises eight Cohorts, which are outlined below:

Phase 1b dose levels: Cohort A (0.15 mg/day), B (0.6 mg/day), C (2 mg/day), and D (5 mg/day).
Phase 2a dose levels: Cohort E (0.15 mg/day), F (0.6 mg/day), G (2 mg/day) and H (placebo).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
KPG-818 low dose in Phase 1b	Active comparator	Drug: KPG-818 low dose in phase 1bCohort A for phase 1b (Open label). Number of patients: 6. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.15 mg/day. Frequency: once daily. Duration of treatment: 14 days.
KPG-818 mid dose in Phase 1b	Active comparator	Drug: KPG-818 mid dose in phase 1bCohort B for phase 1b (Open label) . Number of patients: 6. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.6 mg/day. Frequency: once daily. Duration of treatment: 14 days.
KPG-818 high dose in Phase 1b	Active comparator	Drug: KPG-818 high dose in phase 1bCohort C for phase 1b (Open label) . Number of patients: 8. Drug name: KPG-818. Dosage form: capsule. Dosage: 2.0 mg/day. Frequency: once daily. Duration of treatment: 14 days.
KPG-818 ultra-high dose in Phase 1b	Active comparator	Drug: KPG-818 ultra-high dose in phase 1bCohort D for phase 1b (Open label) . Number of patients: 7. Drug name: KPG-818. Dosage form: capsule. Dosage: 5.0 mg/day. Frequency: once daily. Duration of treatment: 14 days.
KPG-818 low dose in Phase 2a	Active comparator	Drug: KPG-818 low dose in phase 2aCohort E for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.15 mg/day. Frequency: once daily. Duration of treatment: 12 weeks.
KPG-818 mid dose in Phase 2a	Active comparator	Drug: KPG-818 mid dose in phase 2aCohort F for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818. Dosage form: capsule. Dosage: 0.6 mg/day. Frequency: once daily. Duration of treatment: 12 weeks.
KPG-818 high dose in Phase 2a	Active comparator	Drug: KPG-818 high dose in phase 2aCohort G for phase 2a (double-blinded). Number of patients: 10. Drug name: KPG-818. Dosage form: capsule. Dosage: 2.0 mg/day. Frequency: once daily. Duration of treatment: 12 weeks.
KPG-818 Placebo in Phase 2a	Placebo comparator	Drug: KPG-818 Placebo in phase 2aCohort H for phase 2a (double-blinded). Number of patients: 9. Drug name: KPG-818 placebo. Dosage form: capsule. Dosage: NA. Frequency: once daily. Duration of treatment: 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KPG-818 low dose in phase 1bAlso: low dose in phase 1bPatients received 0.15 mg/day of KPG-818 once daily for up to 14 days.	Drug	KPG-818 low dose in Phase 1b
KPG-818 mid dose in phase 1bAlso: mid dose in phase 1bPatients received 0.6 mg/day of KPG-818 once daily for up to 14 days.	Drug	KPG-818 mid dose in Phase 1b
KPG-818 high dose in phase 1bAlso: high dose in phase 1bPatients received 2.0 mg/day of KPG-818 once daily for up to 14 days.	Drug	KPG-818 high dose in Phase 1b
KPG-818 ultra-high dose in phase 1bAlso: ultra-high dose in phase 1bPatients received 5.0 mg/day of KPG-818 once daily for up to 14 days.	Drug	KPG-818 ultra-high dose in Phase 1b
KPG-818 low dose in phase 2aAlso: low dose in phase 2aPatients received 0.15 mg/day of KPG-818 once daily for up to 84 days.	Drug	KPG-818 low dose in Phase 2a
KPG-818 mid dose in phase 2aAlso: mid dose in phase 2aPatients received 0.6 mg/day of KPG-818 once daily for up to 84 days.	Drug	KPG-818 mid dose in Phase 2a
KPG-818 high dose in phase 2aPatients received 2.0 mg/day of KPG-818 once daily for up to 84 days.	Drug	KPG-818 high dose in Phase 2a
KPG-818 Placebo in phase 2aAlso: Placebo in phase 2aPatients received KPG-818 Placebo once daily for up to 84 days.	Drug	KPG-818 Placebo in Phase 2a

Primary outcome

Safety / Tolerability (Assessed by Adverse Events)
Time frame: 4 weeks for phase 1b and 16 weeks for phase 2a
AEs were coded by the MedDRA (version 24.0 or later) and graded for severity according to CTCAE version 5.0. Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) that started or got worsened on or after the first dose of study medication.
Phase 1b - PK Assessment: AUC0-last of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUC0-last defined as the area under the plasma concentration-time curve from time 0 to the last measurable concentration, was calculated from plasma concentrations of KPG-818 using the linear-log trapezoidal method. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUC0-∞ defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity, was calculated as AUClast + Clast/ λz, where Clast was the last measurable concentration. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: AUCτ of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUCτ defined as the area under the concentration-time curve at steady state (the area under the plasma concentration-time curve over a dosing interval). AUCτ was calculated using the linear trapezoidal method and was computed from the time of dosing to dosing time + τ (τ = 24 hours), using the estimated concentration at τ. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: Css_max of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Css_max defined as the peak concentrations at steady state. Css_max was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: Css_min of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Css_min defined as the trough concentrations at steady state. Css_min was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: Tmax of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
tmax defined as time to reach Cmax. If the maximum value occurs at more than 1 time point, tmax was defined as the first time point with this value. tmax was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: t1/2 of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
t1/2 defined as terminal elimination half-life. Calculated as ln(2)\ λz. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: CL/F,ss of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
CL/F,ss defined as apparent total body clearance at steady-state. Calculated as dose/ AUCτ. KPG-818H is the primary metabolite of KPG-818.
Phase 1b - PK Assessment: Vz/F,ss of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Vz/F,ss defined as apparent volume of distribution at steady-state. Calculated as dose/(λz × AUCτ). KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: AUC0-last of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUC0-last defined as the area under the plasma concentration-time curve from time 0 to the last measurable concentration, was calculated from plasma concentrations of KPG-818 using the linear-log trapezoidal method. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUC0-∞ defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity, was calculated as AUClast + Clast/ λz, where Clast was the last measurable concentration. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: AUCτ of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
AUCτ defined as the area under the concentration-time curve at steady state (the area under the plasma concentration-time curve over a dosing interval). AUCτ was calculated using the linear trapezoidal method and was computed from the time of dosing to dosing time + τ (τ = 24 hours), using the estimated concentration at τ. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: Css_max of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Css_max defined as the peak concentrations at steady state. Css_max was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: Css_min of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Css_min defined as the trough concentrations at steady state. Css_min was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: Tmax of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
tmax defined as time to reach Cmax. If the maximum value occurs at more than 1 time point, tmax was defined as the first time point with this value. tmax was observed directly from data. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: t1/2 of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
t1/2 defined as terminal elimination half-life. Calculated as ln(2)\ λz. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: CL/F,ss of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
CL/F,ss defined as apparent total body clearance at steady-state. Calculated as dose/ AUCτ. KPG-818H is the primary metabolite of KPG-818.
Phase 2a - PK Assessment: Vz/F,ss of KPG-818 & KPG-818H
Time frame: The PK blood samples were collected at 30 minutes predose on Day 14, and at 1, 2, 6, 10, and 24 hours postdose on the same day.
Vz/F,ss defined as apparent volume of distribution at steady-state. Calculated as dose/(λz × AUCτ). KPG-818H is the primary metabolite of KPG-818.

2 secondary outcomes

Phase 2a - Mean Change From Baseline in SLEDAI-2K Score at Week 4, 8, 12, and 16
Time frame: At Week 4, 8, 12, and 16
Phase 2a - Mean Change From Baseline in CLASI Score at Week 4, 8, 12, 16
Time frame: At Week 4, 8, 12, 16

Results and safety

Results posted to the registry on 29 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KPG-818 Low Dose in Phase 1b	6	6
KPG-818 Mid Dose in Phase 1b	6	6
KPG-818 High Dose in Phase 1b	8	4
KPG-818 Ultra-high Dose in Phase 1b	7	5
KPG-818 Low Dose in Phase 2a	9	9
KPG-818 Mid Dose in Phase 2a	9	7
KPG-818 High Dose in Phase 2a	10	10
KPG-818 Placebo in Phase 2a	9	9

Primary outcome: Safety / Tolerability (Assessed by Adverse Events)

Time frame: 4 weeks for phase 1b and 16 weeks for phase 2a. Count of participants. Unit: Participants

Measure	KPG-818 Mid Dose in Phase 1b n = 6	KPG-818 High Dose in Phase 1b n = 8	KPG-818 Ultra-high Dose in Phase 1b n = 7	KPG-818 Low Dose in Phase 2a n = 9	KPG-818 Mid Dose in Phase 2a n = 9	KPG-818 High Dose in Phase 2a n = 10	KPG-818 Placebo in Phase 2a n = 9
TEAEs	1	6	6	5	7	9	4
Serious TEAEs	0	1	0	0	1	0	0
Treatment-related TEAEs	0	4	4	1	4	7	2
TEAEs leading to death	0	0	0	0	0	0	0

Population analysed: No any difference between the numbers here and the numbers of participants or units assigned to the arms or groups in the Participant Flow.

Primary outcome: Phase 1b - PK Assessment: AUC0-last of KPG-818 & KPG-818H

Time frame: The PK blood samples were collected at 30 minutes predose on Day 7, and at 1, 2, 6, 10, and 24 hours postdose on the same day.. Geometric mean (Geometric Coefficient of Variation). Unit: AUC0-last [h*ng/mL]

Measure	KPG-818 Low Dose in Phase 1b n = 6	KPG-818 Mid Dose in Phase 1b n = 6	KPG-818 High Dose in Phase 1b n = 5	KPG-818 Ultra-high Dose in Phase 1b n = 6
KPG-818	16.68 (36.87)	60.88 (68.74)	220.48 (22.63)	738.64 (66.63)
KPG-818H	4.51 (34.34)	15.22 (61.81)	51.27 (24.13)	153.03 (79.05)

Population analysed: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Primary outcome: Phase 1b - PK Assessment: AUC0-∞ of KPG-818 & KPG-818H

Measure	KPG-818 Low Dose in Phase 1b n = 6	KPG-818 Mid Dose in Phase 1b n = 6	KPG-818 High Dose in Phase 1b n = 5	KPG-818 Ultra-high Dose in Phase 1b n = 6
KPG-818	19.15 (32.47)	58.58 (76.47)	291.44 (15.61)	899.06 (80.46)
KPG-818H	6.28 (34.9)	16.78 (124.5)	77.37 (30.74)	192.67 (132.75)

Population analysed: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

Primary outcome: Phase 1b - PK Assessment: AUCτ of KPG-818 & KPG-818H

Measure	KPG-818 Low Dose in Phase 1b n = 6	KPG-818 Mid Dose in Phase 1b n = 6	KPG-818 High Dose in Phase 1b n = 5	KPG-818 Ultra-high Dose in Phase 1b n = 6
KPG-818	16.68 (36.87)	60.88 (98.74)	220.48 (22.63)	738.64 (66.63)
KPG-818H	4.51 (34.34)	15.22 (61.81)	51.27 (24.13)	153.03 (79.05)

Population analysed: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase 1b: From screening until end of follow-up, up to 10 weeks. Phase 2a: From screening until end of follow-up, up to 20 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KPG-818 Low Dose in Phase 1b	0 of 6 (0%)	0 of 6 (0%)	0 of 6
KPG-818 Mid Dose in Phase 1b	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
KPG-818 High Dose in Phase 1b	1 of 8 (12.5%)	5 of 8 (62.5%)	0 of 8
KPG-818 Ultra-high Dose in Phase 1b	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
KPG-818 Low Dose in Phase 2a	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
KPG-818 Mid Dose in Phase 2a	1 of 9 (11.1%)	6 of 9 (66.7%)	0 of 9
KPG-818 High Dose in Phase 2a	0 of 10 (0%)	9 of 10 (90%)	0 of 10
KPG-818 Placebo in Phase 2a	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Kangpu Biopharmaceuticals, Ltd.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety / Tolerability (Assessed by Adverse Events) (time frame: 4 weeks for phase 1b and 16 weeks for phase 2a). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04643067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.