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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05504187
• Other study ID #: KP104-202
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2023
• Source: Kira Pharmacenticals (US), LLC.
• Contact: Study Director
• Email: privacy[@]kirapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Thrombotic Microangiopathies

Intervention

Drug:
• KP104
KP104 will be administered.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kira Pharmacenticals (US), LLC.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part 2: Percent change from Baseline in platelet count		Baseline (Day 1) and up to Week 12
Primary	Part 2: Percent change from Baseline in serum lactate dehydrogenase (LDH) levels		Baseline (Day 1) and up to Week 12