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A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

StatusActive, Not Recruiting
PhasePhase 3
SponsorBiogen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 10 words Secondary endpoints: details revised at 11 of 40 entries · Site details revised at 17 of 65 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 11 of 40 entries
    • Site details revised at 17 of 65 sites
  2. Enrollment target: estimated 142 to confirmed 152 Eligibility criteria expanded, about 1 wordv33 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jul 17, 2024 to May 20, 2027 Trial status: Recruiting to Active, Not Recruiting · Study sites: 66 to 65v32 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 66 to 65
  4. Study sites revised (66)v31 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Nov 5, 2029 to Jul 17, 2024 Completion date: Nov 5, 2029 to May 20, 2027v30 Show 1 more changeShow less
    • Completion date: Nov 5, 2029 to May 20, 2027
Show 28 earlier versionsHide 28 earlier versions
  1. Primary endpoints revised (2) Secondary endpoints revised (40)v29 Show 1 more changeShow less
    • Secondary endpoints revised (40)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 67 to 66v28
  3. Study sites: 63 to 67v27
  4. Site details revised at 10 of 63 sitesv26
  5. Primary and study completion dates: Mar 31, 2023 to Nov 5, 2029 Study sites: 64 to 63v25 Show 1 more changeShow less
    • Study sites: 64 to 63
  6. Re-verified, no change to tracked fieldsv24
  7. Study sites: 65 to 64v23
  8. Study sites: 64 to 65v22
  9. Site details revised at 2 of 64 sitesv21
  10. Site details revised at 4 of 64 sitesv20
  11. Site details revised at 1 of 64 sitesv19
  12. Study sites: 65 to 64v18
  13. Study sites: 64 to 65v17
  14. Study sites: 60 to 64v16
  15. Study sites: 61 to 60v15
  16. Study sites: 59 to 61v14
  17. Study sites: 61 to 59v13
  18. Study sites: 60 to 61v12
  19. Study sites: 62 to 60v11
  20. Site details revised at 1 of 62 sitesv10
  21. Site details revised at 27 of 62 sitesv9
  22. Site details revised at 5 of 62 sitesv8
  23. Study sites: 9 to 62 Start date changed from estimate of Oct 31, 2019 to Oct 18, 2019v7 Show 1 more changeShow less
    • Start date changed from estimate of Oct 31, 2019 to Oct 18, 2019
  24. Study sites: 8 to 9 Start date: Oct 3, 2019 to Oct 31, 2019v6 Show 1 more changeShow less
    • Start date: Oct 3, 2019 to Oct 31, 2019
  25. Study sites: 2 to 8v5
  26. Site details revised at 1 of 2 sitesv4
  27. Study sites: 1 to 2v3
  28. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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
Multiple Sclerosis
991 trials monitored
See 36 trials at risk
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
Trial Details
NCT Number NCT03958877
Lead Sponsor Biogen
Conditions Multiple Sclerosis, Relapsing-Remitting
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov