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Monoclonal Antibodies

Ravulizumab SC Treatment Group for Paroxysmal Nocturnal Hemoglobinuria

Phase 3
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 351
Awards & highlights

Study Summary

This triallooks at how a drug (ravulizumab) affects people with a certain disease (PNH) when taken in different ways.

Eligible Conditions
  • Paroxysmal Nocturnal Hemoglobinuria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 351
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 351 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ctrough Serum Concentration of Ravulizumab
Secondary outcome measures
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Subscale Version 4 Score at Day 71
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Version 4 Score at Day 351
Change From Baseline in Treatment Administration Satisfaction Questionnaire (TASQ) Score at Day 351
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ravulizumab SC Treatment GroupExperimental Treatment2 Interventions
In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by SC maintenance doses of ravulizumab administered via the ravulizumab OBDS on Day 15 and every week (qw) thereafter for a total of 10 weeks of study treatment. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274.
Group II: Ravulizumab IV Treatment GroupActive Control2 Interventions
In the Randomized Treatment Period, participants will receive an IV loading dose of ravulizumab on Day 1 followed by IV maintenance doses of ravulizumab on Day 15. In the Extension Period, ravulizumab SC will be administered via the ravulizumab OBDS from Day 71 qw through Day 1274.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab OBDS
2019
Completed Phase 3
~140
Ravulizumab
2021
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,046 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,141 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,287 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Ravulizumab SC Treatment Group have any harmful side effects?

"There is some evidence to support the efficacy of Ravulizumab SC Treatment Group, as this medication is in Phase 3 clinical trials. Furthermore, multiple rounds of testing have deemed it a safe medication with few side effects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
2019. "Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03748823.
~22 spots leftby Apr 2025
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