ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

Part of paid clinical trials in Duarte, California.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT03056040
Phase
PHASE3
Status
Completed

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria (PNH)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — BIOLOGICAL
    All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilograms (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
  • Eculizumab — BIOLOGICAL
    All treatments were given as IV infusions. Participants received 900 mg of eculizumab q2w.

Study Details

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.

Key Dates

Start date
May 17, 2017
Status verified
Feb 2025
Primary completion
Feb 21, 2022
Completion
Feb 21, 2022

Study Design

Enrollment
202 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ravulizumab
    On Day 1, participants received weight-based doses of ravulizumab ranging from 2400 to 3000 milligrams (mg). Thereafter, weight-based doses of ravulizumab ranging from 3000 to 3600 mg were administered on Days 15, 71, and 127. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 4 years.
  • Active Comparator: Eculizumab
    Participants received 900 mg of eculizumab every 2 weeks (q2w) for 26 weeks. After completion of the 26-week Primary Evaluation Period, participants had the opportunity to enter the Extension Period, wherein participants will receive weight-based doses of ravulizumab for up to 4 years.

Primary Outcome Measure

Percent Change In Lactate Dehydrogenase Levels From Baseline To Day 183 [ Time Frame: Baseline, Day 183 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90089-
Research SiteBaltimoreMaryland21205-
Research SiteDetroitMichigan48202-
Research SiteThe BronxNew York10467-

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