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A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease (CLEAR-AbKD)

10. september 2026 oppdatert av: AstraZeneca

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

43

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Belgia
      • Ieper, Belgia, 8900
        • Har ikke rekruttert ennå
        • Research Site
  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • Har ikke rekruttert ennå
        • Research Site
      • Los Angeles, California, Forente stater, 90022
        • Tilbaketrukket
        • Research Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Har ikke rekruttert ennå
        • Research Site
    • Maryland
      • Bethesda, Maryland, Forente stater, 20889
        • Har ikke rekruttert ennå
        • Research Site
    • New York
      • New York, New York, Forente stater, 10016
        • Har ikke rekruttert ennå
        • Research Site
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Har ikke rekruttert ennå
        • Research Site
      • Houston, Texas, Forente stater, 77027
        • Rekruttering
        • Research Site
  • Frankrike
      • Bordeaux, Frankrike, 33076
        • Har ikke rekruttert ennå
        • Research Site
      • Créteil, Frankrike, 94010
        • Tilbaketrukket
        • Research Site
      • Lyon, Frankrike, 69009
        • Har ikke rekruttert ennå
        • Research Site
      • Nantes, Frankrike, 44093
        • Har ikke rekruttert ennå
        • Research Site
      • Nîmes, Frankrike, 30029
        • Har ikke rekruttert ennå
        • Research Site
  • Italia
      • Brescia, Italia, 25123
        • Har ikke rekruttert ennå
        • Research Site
      • Rozzano, Italia, 20089
        • Har ikke rekruttert ennå
        • Research Site
      • Torino, Italia, 10154
        • Har ikke rekruttert ennå
        • Research Site
      • Verona, Italia, 37126
        • Tilbaketrukket
        • Research Site
  • Polen
      • Lodz, Polen, 92-213
        • Har ikke rekruttert ennå
        • Research Site
  • Spania
      • Barcelona, Spania, 08025
        • Har ikke rekruttert ennå
        • Research Site
      • Madrid, Spania, 28041
        • Har ikke rekruttert ennå
        • Research Site
  • Storbritannia
      • London, Storbritannia, NW3 2PF
        • Har ikke rekruttert ennå
        • Research Site
      • Manchester, Storbritannia, M13 9WL
        • Har ikke rekruttert ennå
        • Research Site
  • Tyskland
      • Düsseldorf, Tyskland, 40225
        • Har ikke rekruttert ennå
        • Research Site
      • München, Tyskland, 80336
        • Har ikke rekruttert ennå
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.
  2. Diagnosis of anti-PLA2R antibody-positive pMN.
  3. All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.
  4. Positive for anti-PLA2R.
  5. Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.
  6. Male and/or female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  7. Capable of giving signed informed consent

Exclusion Criteria:

  1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies < 9 months before screening.
  2. Immunomodulatory therapy <3 months before screening.
  3. Secondary causes of membranous nephropathy
  4. Diabetes mellitus with haemoglobin A1C > 8.5% tested at screening visit.
  5. Malignancies
  6. History of HLH/MAS. 7 Significant CNS co-morbidity

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Surovatamig Arm
Participants will receive Surovatamig
Legemiddel: Surovatamig
Participants will receive Surovatamig subcutaneously

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with adverse events.
Tidsramme: Through study completion, an average of 2 years
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)
Tidsramme: At 6 months
To assess the effect of surovatamig on proteinuria
At 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of participants achieving complete or partial remission of pMN
Tidsramme: At 24 months
To evaluate the proportion of participants who achieve partial and/or complete remission
At 24 months
Percentage of participants achieving complete remission of pMN
Tidsramme: At 24 months
To evaluate the proportion of participants who achieved complete remission
At 24 months
Percentage of participants achieving partial remission of pMN
Tidsramme: At 24 months
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)
Tidsramme: At 24 months
To assess the effect of surovatamig on proteinuria
At 24 months
Change from baseline in anti-PLA2R antibody titer
Tidsramme: At 24 months
To evaluate anti-PLA2R antibodies in blood
At 24 months
Change from baseline in B-cell count in peripheral blood
Tidsramme: At 24 months
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
Tidsramme: At 24 months
Time to relapse after complete or partial remission
At 24 months
Time to a ≥ 3 months sustained reduction of eGFR
Tidsramme: From Baseline to 24 months
Time to a sustained reduction of eGFR
From Baseline to 24 months
Change from baseline in patient-reported experience of symptoms associated with pMN
Tidsramme: Through study completion, an average of 2 years
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
Tidsramme: Through study completion, an average of 2 years
To characterise the PK of surovatamig
Through study completion, an average of 2 years
Treatment-emergent ADAs
Tidsramme: Through study completion, an average of 2 years
To evaluate the immunogenicity of surovatamig
Through study completion, an average of 2 years
Serum PK parameters of surovatamig, as Cmax (Peak Plasma Concentration)
Tidsramme: Through study completion, an average of 2 years
To characterise the PK of surovatamig
Through study completion, an average of 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2026

Primær fullføring (Antatt)

24. april 2028

Studiet fullført (Antatt)

15. oktober 2029

Datoer for studieregistrering

Først innsendt

19. mars 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • D740FC00001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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