Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE
Public ClinicalTrials.gov record NCT04643067. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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". This study was designed to address the following key questions: * 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).
Study identification
- NCT ID
- NCT04643067
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Interventions
- KPG-818 low dose in phase 1b Drug
- KPG-818 mid dose in phase 1b Drug
- KPG-818 high dose in phase 1b Drug
- KPG-818 ultra-high dose in phase 1b Drug
- KPG-818 low dose in phase 2a Drug
- KPG-818 mid dose in phase 2a Drug
- KPG-818 high dose in phase 2a Drug
- KPG-818 Placebo in phase 2a Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 3, 2021 (Actual)
- Primary completion
- Jun 29, 2023 (Actual)
- Completion
- Jun 29, 2023 (Actual)
- Last update posted
- Sep 29, 2026
2021 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 6
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anniston Medical Clinic | Anniston | Alabama | 36207 | — |
| University of Alabama - Birmingham | Birmingham | Alabama | 35205 | — |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | — |
| Hope Clinical Trials, Inc. | Coral Gables | Florida | 33134 | — |
| JY Research Institute Inc | Cutler Bay | Florida | 33189 | — |
| OSIS Clinical Research | Hollywood | Florida | 33020 | — |
| 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 | — |
| Clinical Research of West Florida | Tampa | Florida | 33606 | — |
| Oracle Clinical Research | College Park | Georgia | 30329 | — |
| STAT Research | Vandalia | Ohio | 54377 | — |
| Shelby Research LLC | Memphis | Tennessee | 38119 | — |
| Accurate Clinical Management | Houston | Texas | 77084 | — |
| Accurate Clinical Research LLC | Houston | Texas | 77089 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04643067, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04643067 live on ClinicalTrials.gov.