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Monoclonal Antibodies

T (ABP 959) / R (eculizumab) for Paroxysmal Nocturnal Hemoglobinuria (DAHLIA Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
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, week 3, week 7, week 13, week 15, week 19, week 25, week 27, week 29, week 33, week 39, week 41, week 43, week 45, week 47, week 49, week 51, week 53, week 55, week 59, week 65, week 67, week 69, week 71, week 73, week 75, week 77, and week 79
Awards & highlights

DAHLIA Trial Summary

This study is evaluating whether a drug called ABP 959 can help people with a rare blood disorder called paroxysmal nocturnal hemoglobinuria.

Eligible Conditions
  • Paroxysmal Nocturnal Hemoglobinuria

DAHLIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 3, week 7, week 13, week 15, week 19, week 25, week 27, week 29, week 33, week 39, week 41, week 43, week 45, week 47, week 49, week 51, week 53, week 55, week 59, week 65, week 67, week 69, week 71, week 73, week 75, week 77, and week 79
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3, week 7, week 13, week 15, week 19, week 25, week 27, week 29, week 33, week 39, week 41, week 43, week 45, week 47, week 49, week 51, week 53, week 55, week 59, week 65, week 67, week 69, week 71, week 73, week 75, week 77, and week 79 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
LDH Level at Week 27 (Parallel Comparison)
Time-adjusted Area Under the Effect Curve (AUEC) of LDH (Crossover Comparison Per Assigned Treatment)
Secondary outcome measures
Degree of Hemoglobinuria
LDH Levels at Week 53 and Week 79
Mean Bilirubin Levels
+11 more

DAHLIA Trial Design

2Treatment groups
Experimental Treatment
Group I: T (ABP 959) / R (eculizumab)Experimental Treatment2 Interventions
ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
Group II: R (eculizumab) / T (ABP 959)Experimental Treatment2 Interventions
Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP 959
2019
Completed Phase 3
~50
Eculizumab
2021
Completed Phase 4
~1190

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,378,095 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,568 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
2019. "A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818607.
~7 spots leftby Apr 2025
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