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A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)

Study acronym: PREVAIL
StatusRecruiting
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 261 → 264 locations
  2. Study sites: 260 to 261 Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 2 of 12 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 12 entries
  3. Study sites: 258 to 260v49
  4. Study sites: 256 to 258v48
  5. Trial sites expanded: 251 → 256 locationsv47
  6. Trial sites expanded: 248 → 251 locationsv46
  7. Study sites: 247 to 248v45
  8. Study sites: 246 to 247v44
  9. Site details revised at 2 of 246 sitesv43
  10. Study sites: 244 to 246v42
  11. Trial sites expanded: 240 → 244 locationsv41
  12. Study sites: 239 to 240v40
  13. Trial sites expanded: 235 → 239 locationsv39
  14. Study sites: 233 to 235v38
  15. Trial sites expanded: 228 → 233 locationsv37
  16. Study sites: 227 to 228 Eligibility criteria expanded, about 63 words · Secondary endpoints: details revised at 1 of 12 entries · Collaborators shortened, about 5 wordsv36 Show 3 more changesShow less
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Collaborators shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  17. Trial sites expanded: 222 → 227 locationsv35
  18. Trial sites expanded: 217 → 222 locationsv34
  19. Study sites: 215 to 217v33
  20. Trial sites expanded: 209 → 215 locationsv32
  21. Study sites: 206 to 209v31
  22. Study sites: 196 to 206v30
  23. Study sites: 195 to 196v29
  24. Study sites: 190 to 195v28
  25. Study sites: 182 to 190v27
  26. Study sites: 180 to 182v26
  27. Study sites: 176 to 180v25
  28. Study sites: 143 to 176v24
  29. Study sites: 137 to 143v23
  30. Study sites: 134 to 137v22
  31. Study sites: 123 to 134v21
  32. Study sites: 110 to 123v20
  33. Study sites: 100 to 110v19
  34. Study sites: 73 to 100v18
  35. Study sites: 71 to 73v17
  36. Study sites: 59 to 71v16
  37. Study sites: 48 to 59v15
  38. Study sites: 41 to 48v14
  39. Study sites: 37 to 41v13
  40. Study sites: 23 to 37 Eligibility criteria expanded, about 12 wordsv12 Show 1 more changeShow less
    • Eligibility criteria expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  41. Study sites: 18 to 23v11
  42. Study sites: 15 to 18v10
  43. Study sites: 14 to 15v9
  44. Study sites: 10 to 14v8
  45. Study sites: 9 to 10v7
  46. Study sites: 7 to 9v6
  47. Study sites: 5 to 7v5
  48. Study sites: 4 to 5v4
  49. Study sites: 3 to 4v3
  50. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of May 30, 2025 to May 8, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of May 30, 2025 to May 8, 2025
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biogen
92 trials monitored
See 7 trials at risk
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Trial Details
NCT Number NCT06935357
Lead Sponsor Biogen
Conditions Immunoglobulin A Nephropathy (IgAN)
Enrollment 454 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov