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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| 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. |
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| Part 2: OBD Cohort, Dose 4 | Experimental | Participants will be administered with KP104 OBD for 24 Weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP104 | Drug | KP104 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Only key inclusion and exclusion criteria have been included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | privacy@kirapharma.com |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D057049 | Thrombotic Microangiopathies |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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