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The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.
This is a Phase II open-label study to assess the safety, tolerability, Pharmacokinetics, and efficacy of surovatamig in adult participants with pMN, who are positive for anti-PLA2R antibodies and have heavy and persistent proteinuria with a high risk of progressing to end stage kidney disease.
The study will be conducted across approximately 30 to 40 study sites in approximately 10 countries. The study consists of 2 parts (Part A Multiple ascending with sentinel dosing and Part B Multiple ascending doses), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surovatamig Arm | Experimental | Participants will receive Surovatamig |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surovatamig | Drug | Participants will receive Surovatamig subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events. | To assess the safety and tolerability of surovatamig on adverse events, including Adverse events, Serious adverse events, Adverse event of special interests, and Adverse events leading to discontinuation of surovatamig. | Through study completion, an average of 2 years |
| Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) | To assess the effect of surovatamig on proteinuria | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving complete or partial remission of pMN | To evaluate the proportion of participants who achieve partial and/or complete remission | At 24 months |
| Percentage of participants achieving complete remission of pMN |
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Inclusion Criteria:
Exclusion Criteria:
8. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.
10. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent < 2 months before screening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Not yet recruiting | Los Angeles | California | 90095 | United States | |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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The study consists of 2 parts (Part A and Part B), with each consisting of 3 periods (ie, screening period, treatment period, and follow-up period; up to 26 months in total).
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To evaluate the proportion of participants who achieved complete remission
| At 24 months |
| Percentage of participants achieving partial remission of pMN | To evaluate the proportion of participants who achieve partial remission | At 24 months |
| Change from baseline in UPCR (from 24-hour urine collection or the intended 24-hour urine collection) | To assess the effect of surovatamig on proteinuria | At 24 months |
| Change from baseline in anti-PLA2R antibody titer | To evaluate anti-PLA2R antibodies in blood | At 24 months |
| Change from baseline in B-cell count in peripheral blood | To assess the effect of surovatamig by assessment of B-cell depletion in blood | At 24 months |
| Time to relapse after complete or partial remission | Time to relapse after complete or partial remission | At 24 months |
| Time to a ≥ 3 months sustained reduction of eGFR | Time to a sustained reduction of eGFR | From Baseline to 24 months |
| Change from baseline in patient-reported experience of symptoms associated with pMN | To evaluate the change in patient-reported experience | Through study completion, an average of 2 years |
| Serum PK parameters of surovatamig, AUC Area under the plasma concentration versus time curve | To characterise the PK of surovatamig | Through study completion, an average of 2 years |
| Treatment-emergent ADAs | To evaluate the immunogenicity of surovatamig | Through study completion, an average of 2 years |
| Serum PK parameters of surovatamig, as Cmax (Peak Plasma Concentration) | To characterise the PK of surovatamig | Through study completion, an average of 2 years |
| Research Site |
| Not yet recruiting |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Research Site | Not yet recruiting | Bethesda | Maryland | 20889 | United States |
| Research Site | Not yet recruiting | New York | New York | 10016 | United States |
| Research Site | Recruiting | Houston | Texas | 77027 | United States |
| Research Site | Not yet recruiting | Houston | Texas | 77030 | United States |
| Research Site | Not yet recruiting | Ieper | 8900 | Belgium |
| Research Site | Not yet recruiting | Bordeaux | 33076 | France |
| Research Site | Withdrawn | Créteil | 94010 | France |
| Research Site | Not yet recruiting | Lyon | 69009 | France |
| Research Site | Not yet recruiting | Nantes | 44093 | France |
| Research Site | Not yet recruiting | Nîmes | 30029 | France |
| Research Site | Not yet recruiting | Düsseldorf | 40225 | Germany |
| Research Site | Not yet recruiting | Brescia | 25123 | Italy |
| Research Site | Not yet recruiting | Rozzano | 20089 | Italy |
| Research Site | Not yet recruiting | Torino | 10154 | Italy |
| Research Site | Withdrawn | Verona | 37126 | Italy |
| Research Site | Not yet recruiting | Lodz | 92-213 | Poland |
| Research Site | Not yet recruiting | Barcelona | 08025 | Spain |
| Research Site | Not yet recruiting | Madrid | 28041 | Spain |
| Research Site | Not yet recruiting | London | NW3 2PF | United Kingdom |
| Research Site | Not yet recruiting | Manchester | M13 9WL | United Kingdom |