Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05935215
Phase
PHASE3
Status
Recruiting
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Conditions

  • Atypical Hemolytic Uremic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.

Key Dates

Start date
Feb 28, 2024
Status verified
Apr 2026
Primary completion
Jul 21, 2028
Completion
Jul 19, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: iptacopan 200 mg b.i.d.
    open label arm of iptacopan 200 mg b.i.d.

Primary Outcome Measure

Percentage of participants free of TMA manifestation [ Time Frame: 12 months ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

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