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A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines

Study acronym: RECLAIM
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Trial sites reduced: 132 → 121 locations
    • Enrollment target: estimated 400 to confirmed 409
  2. Study sites: 133 to 132 Show 4 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 4 words
  3. Trial sites expanded: 130 → 133 locationsv10
  4. Study sites: 128 to 130v9
  5. Trial sites expanded: 114 → 128 locationsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 102 to 114v7
  2. Study sites: 74 to 102
    • Primary completion date: May 11, 2027 to Feb 22, 2027
    • Study completion date: Aug 3, 2027 to May 17, 2027
    v6
  3. Study sites: 59 to 74v5
  4. Study sites: 23 to 59
    • Primary completion date: Apr 22, 2027 to May 11, 2027
    • Study completion date: Aug 23, 2027 to Aug 3, 2027
    v4
  5. Study sites: 3 to 23
    • Start date changed from estimate of Jul 25, 2025 to Jul 11, 2025
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary completion date: Mar 22, 2027 to Apr 22, 2027
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
See 34 trials at risk
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
Trial Details
NCT Number NCT06868212
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Chronic Spontaneous Urticaria (CSU)
Related terms Chronic Urticaria
Enrollment 409 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov