NCT05504187

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
11mo left

Started Mar 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2025Apr 2027

First Submitted

Initial submission to the registry

August 15, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

August 15, 2022

Last Update Submit

October 25, 2024

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusThrombotic microangiopathyDose SelectionProof of ConceptKP-104

Outcome Measures

Primary Outcomes (3)

  • Parts 1 and 2: Number of participants with Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESIs)

    Up to 24 weeks

  • Part 2: Percent change from Baseline in platelet count

    Baseline (Day 1) and up to Week 12

  • Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels

    Baseline (Day 1) and up to Week 12

Study Arms (4)

Part 1: Dose Optimization Cohort 1, Dose 1

EXPERIMENTAL

Participants will be administered with KP104 as a weekly maintenance dose for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the Internal Data Review Committee (IDRC) to determine Dosing Regimen 2

Drug: KP104

Part 1: Dose Optimization Cohort 2, Dose 2

EXPERIMENTAL

Participants will be administered with KP104 dose regimen 2 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the IDRC to determine Dosing Regimen 3.

Drug: KP104

Part 1: Dose Optimization Cohort 3, Dose 3

EXPERIMENTAL

Participants will be administered with KP104 dose regimen 3 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by IDRC to determine the Optimal biologic dose (OBD) for Part 2.

Drug: KP104

Part 2: OBD Cohort, Dose 4

EXPERIMENTAL

Participants will be administered with KP104 OBD for 24 Weeks.

Drug: KP104

Interventions

KP104DRUG

KP104 will be administered.

Part 1: Dose Optimization Cohort 1, Dose 1Part 1: Dose Optimization Cohort 2, Dose 2Part 1: Dose Optimization Cohort 3, Dose 3Part 2: OBD Cohort, Dose 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
  • Decrease in platelet count to less than (\<)150,000/microliters (mcL).
  • Abnormal renal function.
  • Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.
  • Willing and able to provide informed consent.
  • Evidence of microangiopathic hemolytic anemia

You may not qualify if:

  • Diagnosis of other TMA syndromes.
  • A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.
  • Positive Coombs test at the time of TMA diagnosis.
  • Active or unresolved Neisseria meningitidis infection at screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, SystemicThrombotic Microangiopathies

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Central Study Contacts

Study Director

CONTACT

privacy@kirapharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 17, 2022

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share