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Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

KP104

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Thrombotic microangiopathy, Dose Selection, Proof of Concept, KP-104

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 (<)100,000/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

Exclusion Criteria:

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.
Positive nasopharyngeal swab for Neisseria meningitidis at Screening or a prior history of meningitis.

Only key inclusion and exclusion criteria have been included.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part 1: Dose Optimization Cohort 1, Dose 1

Part 1: Dose Optimization Cohort 2, Dose 2

Part 1: Dose Optimization Cohort 3, Dose 3

Part 2: OBD Cohort, Dose 4

Arm Description

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

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.

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.

Participants will be administered with KP104 OBD for 24 Weeks.

Outcomes

Primary Outcome Measures

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)

Part 2: Percent change from Baseline in platelet count

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05504187

First Posted

August 15, 2022

Last Updated

March 6, 2023

Sponsor

Kira Pharmacenticals (US), LLC.

1. Study Identification

Unique Protocol Identification Number

NCT05504187

Brief Title

Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Official Title

An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kira Pharmacenticals (US), LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus, Thrombotic microangiopathy, Dose Selection, Proof of Concept, KP-104

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Dose Optimization Cohort 1, Dose 1

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Dose Optimization Cohort 2, Dose 2

Arm Type

Experimental

Arm Description

Arm Title

Part 1: Dose Optimization Cohort 3, Dose 3

Arm Type

Experimental

Arm Description

Arm Title

Part 2: OBD Cohort, Dose 4

Arm Type

Experimental

Arm Description

Participants will be administered with KP104 OBD for 24 Weeks.

Intervention Type

Drug

Intervention Name(s)

KP104

Intervention Description

KP104 will be administered.

Primary Outcome Measure Information:

Title

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)

Time Frame

Up to 24 weeks

Title

Part 2: Percent change from Baseline in platelet count

Time Frame

Baseline (Day 1) and up to Week 12

Title

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

Time Frame

Baseline (Day 1) and up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Only key inclusion and exclusion criteria have been included.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Director

privacy@kirapharma.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus

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