Dose-Escalation Study of ALXN1210 IV in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study Identifier:
ALXN1210-PNH-103
ClinicalTrials.gov Identifier:
NCT02598583
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • PNH
Study Drug
  • Biological: ALXN1210
Date
Nov 2015 - Jul 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male or female ≥18 years of age
  • PNH diagnosis confirmed by documented high-sensitivity flow cytometry
  • Documented meningococcal vaccination not more than 3 years prior to dosing
  • Female participants of childbearing potential used highly effective contraception starting at screening and continuing until at least 24-weeks after the last dose of ALXN1210
  • Willing and able to give written informed consent and comply with the study visit schedule
Exclusion Criteria
  • Treatment with a complement inhibitor at any time
  • Females who were pregnant, breastfeeding or who had a positive pregnancy test at screening or Day 1
  • Participation in an interventional clinical study within 30 days before initiation of dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on Day 1, or within 5 half-lives of the product, whichever is greater
  • History of allergy to excipients of ALXN1210 or known allergy to Chinese hamster ovary cell proteins
  • Inability to comply with study requirements
  • History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, made the participant unsuitable for enrollment
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • PNH
Study Drug
  • Biological: ALXN1210
Date
Nov 2015 - Jul 2016
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male or female ≥18 years of age
  • PNH diagnosis confirmed by documented high-sensitivity flow cytometry
  • Documented meningococcal vaccination not more than 3 years prior to dosing
  • Female participants of childbearing potential used highly effective contraception starting at screening and continuing until at least 24-weeks after the last dose of ALXN1210
  • Willing and able to give written informed consent and comply with the study visit schedule
Exclusion Criteria
  • Treatment with a complement inhibitor at any time
  • Females who were pregnant, breastfeeding or who had a positive pregnancy test at screening or Day 1
  • Participation in an interventional clinical study within 30 days before initiation of dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on Day 1, or within 5 half-lives of the product, whichever is greater
  • History of allergy to excipients of ALXN1210 or known allergy to Chinese hamster ovary cell proteins
  • Inability to comply with study requirements
  • History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or rheumatoid disease that, in the Investigator's judgment, would preclude participation
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, made the participant unsuitable for enrollment

Protocol Summary

This study evaluated the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of multiple intravenous (IV) doses of ALXN1210 administered to participants with PNH who have not previously been treated with complement inhibitor.

Trial Locations

Location
Status
Location
Clinical Trial Site
Liverpool, New South Wales, Australia, 2170
Status
N/A
Location
Clinical Trial Site
Woolloongabba, Queensland, Australia, 4102
Status
N/A
Location
Clinical Trial Site
Seoul, Republic of Korea, 03080
Status
N/A
Location
Clinical Trial Site
Seoul, Republic of Korea, 03722
Status
N/A
Location
Clinical Trial Site
Seoul, Republic of Korea, 05505
Status
N/A
Location
Clinical Trial Site
Seoul, Republic of Korea, 06351
Status
N/A
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