Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies
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ClinicalTrials.gov Identifier: NCT03453619 |
Recruitment Status : Unknown
Verified August 2020 by Apellis Pharmaceuticals, Inc..
Recruitment status was: Active, not recruiting
First Posted : March 5, 2018
Last Update Posted : September 2, 2020
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Sponsor:
Apellis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | February 27, 2018 | ||||
First Posted Date ICMJE | March 5, 2018 | ||||
Last Update Posted Date | September 2, 2020 | ||||
Actual Study Start Date ICMJE | January 22, 2018 | ||||
Actual Primary Completion Date | April 16, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proteinuria [ Time Frame: 48 weeks ] Proteinuria reduction by 50%, calculated by the change in uPCR from baseline to Week 48.
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Original Primary Outcome Measures ICMJE |
Changes in Proteinuria [ Time Frame: 16 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies | ||||
Official Title ICMJE | A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease) | ||||
Brief Summary | This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: APL-2
APL-2 administered as a daily subcutaneous infusion for 48 weeks
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Study Arms ICMJE | Experimental: APL-2
Open Label, Study Drug, APL-2
Intervention: Drug: APL-2
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE |
21 | ||||
Original Estimated Enrollment ICMJE |
36 | ||||
Estimated Study Completion Date ICMJE | December 2022 | ||||
Actual Primary Completion Date | April 16, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03453619 | ||||
Other Study ID Numbers ICMJE | APL2-201 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Apellis Pharmaceuticals, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Apellis Pharmaceuticals, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Apellis Pharmaceuticals, Inc. | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |