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A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH (DAHLIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03818607
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Hemolysis as measured by Lactate dehydrogenas (LDH) (Parallel Comparison) [ Time Frame: 12 months ]
  • Hemolysis as measured by LDH (Crossover Comparison) [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH
Official Title  ICMJE 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)
Brief Summary This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Nocturnal Hemoglobinuria
Intervention  ICMJE
  • Drug: ABP 959
    intravenous infusion
    Other Name: Treatment T
  • Drug: Eculizumab
    intravenous infusion
    Other Names:
    • Soliris
    • Treatment R
Study Arms  ICMJE
  • T (ABP 959) / R (eculizumab)
    ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2
    Interventions:
    • Drug: ABP 959
    • Drug: Eculizumab
  • R (eculizumab) / T (ABP 959)
    Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2
    Interventions:
    • Drug: ABP 959
    • Drug: Eculizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Historical diagnosis of PNH.
  • Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab.
  • 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 any procedures.

Exclusion Criteria:

  • Known or suspected hereditary complement deficiency.
  • Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia), peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.
  • Evidence of acute thrombosis (liver Doppler ultrasound of hepatic and portal veins).
  • 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 since ending 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 the study, including mammalian cell-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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Czechia,   Finland,   France,   Ireland,   Italy,   Netherlands,   Norway,   Portugal,   Slovenia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03818607
Other Study ID Numbers  ICMJE 20150168
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP