Clinical Trial Summary : 20150168
A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH  (DAHLIA) FDA Regulated: No

This study is currently recruiting participants.
Verified by Amgen, July 2020

Sponsored by: Amgen
Information provided by: Amgen

Purpose

This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.


Condition Intervention Phase
Paroxysmal Nocturnal Hemoglobinuria
Drug: ABP 959
Drug: Eculizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking Description: double-blind
No Masking: false
Official Title: A Randomized, Double-Blind, Active-Controlled Phase 3 Study evaluating the Efficacy and Safety of ABP 959 compared with Eculizumab in Adult Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)


Further study details as provided by Amgen

Primary Outcome Measures:
  • Hemolysis as measured by Lactate dehydrogenas (LDH) (Parallel Comparison) [ Time Frame: 12 months ]

  • Hemolysis as measured by LDH (Crossover Comparison) [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Total hemolytic complement (Total Complement) [ Time Frame: 18 months ]

  • Total hemoglobin [ Time Frame: 18 months ]

  • Serum-free hemoglobin [ Time Frame: 18 months ]

  • Haptoglobin [ Time Frame: 18 months ]

  • Bilirubin [ Time Frame: 18 months ]

  • Degree of hemoglobinuria [ Time Frame: 18 months ]

  • Type III erythrocytes [ Time Frame: 18 months ]

  • Crossover comparison of hemolysis as measured by LDH [ Time Frame: 18 months ]

  • Lactate dehydrogenase-time profile [ Time Frame: 18 months ]

  • Incidence of red blood cell transfusion [ Time Frame: 18 months ]

  • Pharmacokinetic area under the curve (AUC) of ABP 959 [ Time Frame: 18 months ]

  • Pharmacokinetic area under the curve (AUC) of eculizumab [ Time Frame: 18 months ]

Estimated Enrollment: 40
Study Start Date:2019 April DDDD Study Start Date Type: Actual

Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: T (ABP 959) / R (eculizumab)
ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
Drug: ABP 959
intravenous infusion
Other Name: Treatment T
Drug: Eculizumab
intravenous infusion
Other Name: Soliris
Other Name: Treatment R
Other: R (eculizumab) / T (ABP 959)
Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
Drug: ABP 959
intravenous infusion
Other Name: Treatment T
Drug: Eculizumab
intravenous infusion
Other Name: Soliris
Other Name: Treatment R


Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  All
Gender Based:  No
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:
• Men and women ≥ 18 years of age.
• Historical diagnosis of PNH.
• Administration of eculizumab for ≥ 6 months and currently receiving 900 mg ofeculizumab.
• Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization.
• Lactate dehydrogenase < 1.5 × the upper limit of normal at screening.
• Platelet count ≥ 50 × 10^9/L.
• Absolute neutrophil count (ANC) > 0.5 x 10^9/L (500/μL).
• Participants must be vaccinated against Neisseria meningitidis.
• Participants must sign an IRB/IEC-approved ICF before participation in anyprocedures.

Exclusion Criteria:
• Known or suspected hereditary complement deficiency.
• Clinically significant cardiovascular disease (including myocardial infarction,unstable angina, symptomatic congestive heart failure [New York HeartAssociation ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheralvascular disease, cerebrovascular accident, or transient ischemic attack in theprevious 6 months.
• Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portalveins).
• Known to be positive for human immunodeficiency virus.
• Woman who is pregnant or breastfeeding.
• Participant is currently enrolled in or has not yet completed at least 30 days sinceending other investigational device or drug study(s), or participant is receiving other investigational agent(s).
• Participant has known sensitivity to any of the products to be administered during
• derived drug products.
• History of meningococcal infection.
• Presence or suspicion of active bacterial infection, or recurrent bacterial infection.
• History of bone marrow transplantation.
• Red blood cell transfusion required within 12 weeks before randomization.
• Participant experienced ≥ 2 breakthrough events, (ie, signs and symptoms of intravascular hemolysis, that require dose and/or schedule adjustments of eculizumab) in the previous 12 months before screening.


Contacts and Locations

Contacts
Contact:  Call Center 866-572-6436 medinfo@amgen.com

 Show 28 Study Locations

Sponsors and Collaborators
Amgen
Oversight
Is FDA Regulated Intervention: No
U.S. FDA IND/IDE Study: Yes

Investigators
Study Director: MD   Amgen

More Information
Responsible Party:
Other Study ID Numbers: 20150168
Health Authority:
U.S. FDA-regulated Drug Yes
U.S. FDA-regulated Device No
Post Prior to Approval/Clearance
Pediatric Postmarket Surveillance
Product Exported From U.S.

Keywords provided by Amgen:

Marchiafava-Micheli Syndrome
Paroxysmal Cold Hemoglobinuria