Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Lead sponsor: Galderma R&D to Galderma R&D Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 1935 participants (planned 1700)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 19 entries
    • Site details revised at 3 of 343 sites
    • Publications: details revised at 2 of 2 entries
  2. 2 versions Re-verified since Jun 17, 2024, no change to tracked fieldsv26-v27
  3. Study sites: 351 to 343v25
  4. Trial status: Enrolling by Invitation to Active, Not Recruitingv24
  5. Re-verified, no change to tracked fieldsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised at 351 of 351 sites
    v22
  2. Primary and study completion dates: Sep 30, 2023 to Aug 31, 2026v21
  3. Primary endpoints: 2 to 3
    • Enrollment target: 1300 to 1700
    • Secondary endpoints: 12 to 19
    • Site details revised at 4 of 351 sites
    v20
  4. Study sites: 350 to 351v19
  5. Study sites: 346 to 350v18
  6. Study sites: 343 to 346v17
  7. Site details revised at 7 of 343 sitesv16
  8. Study sites: 335 to 343v15
  9. Study sites: 333 to 335v14
  10. Study sites: 165 to 333v13
  11. Study sites: 149 to 165
    • Eligibility criteria expanded, about 56 words
    v12
  12. Re-verified, no change to tracked fieldsv11
  13. Study sites: 38 to 149v10
  14. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised at 38 of 38 sites
    v9
  15. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 31 to 38
    v8
  16. Re-verified, no change to tracked fieldsv7
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 34 to 31
    v6
  18. Start date: Nov 30, 2019 to Dec 30, 2019v5
  19. Start date: Jul 28, 2019 to Nov 30, 2019v4
  20. Start date: Jun 28, 2019 to Jul 28, 2019v3
  21. Secondary endpoints revised (12)v2
  1. Study First Submitted
  • 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.
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Trial Details
NCT Number NCT03989206
Lead Sponsor Galderma R&D
Conditions
(from sponsor)		 Moderate-to-Severe Atopic Dermatitis
Enrollment 1,935 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov