EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

• Register: EUCTR
• Last refreshed on: 23 May 2022
• Main ID: EUCTR2013-001151-12-HR
• Date of registration: 01/02/2016
• Prospective Registration: No
• Primary sponsor: Alexion Pharmaceuticals, Inc.
• Public title: EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS
• Scientific title: A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)
• Date of first enrolment: 08/12/2015
• Target sample size: 132
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001151-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Martinique, Peru, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: European Clinical Trial Information
• Affiliation: ALEXION EUROPE SAS

• Name: European Clinical Trial Information
• Affiliation: ALEXION EUROPE SAS

Key inclusion & exclusion criteria

Inclusion criteria:
- Male or female patient = 18 years old
- Patient who completed the ECU-NMO-301 trial
- Patients who completed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion criteria:
- Patient withdrew from the ECU-NMO-301 trial as a result of an AE related to trial drug
- Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
- Any medical condition or circumstances that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial, pose any added risk for the patient, or confound the assessment of the patients.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Neuromyelitis Optica
MedDRA version: 20.0 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: SOLIRIS
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ECULIZUMAB
CAS Number: 219685-50-4
Current Sponsor code: h5G1.1-mAb
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: Long-term safety of eculizumab in patients with relapsing NMO.

Secondary Objective: Long-term efficacy of eculizumab in patients with relapsing NMO Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in relapsing NMO patients.

Primary end point(s): - Safety: Trial emergent adverse effects

Timepoint(s) of evaluation of this end point: Trial period

Secondary Outcome(s)

Secondary end point(s): - On-Trial relapse
- EDSS and mRS score change from baseline
- FSS score
- Quality of life

Timepoint(s) of evaluation of this end point: Evaluation at:
- Blind induction phase (day 1, week 4)
- Open label phase (week 8, 12, 26, 40, 52, 66, 78, 92, 116, 130, 144, 170, 182, 196)
- Relapse Evaluation Visits (within 48 hours, and at week +1, 4 weeks, 6 weeks after relapse)
- End of trial visit (week 104 or 156 or 208)

Secondary ID(s)

2013-001151-12-DE

ECU-NMO-302

Source(s) of Monetary Support

ALEXION PHARMACEUTICALS INC

Ethics review

Status: Approved
Approval date: 16/04/2015
Contact: