STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

• Register: EUCTR
• Last refreshed on: 3 August 2020
• Main ID: EUCTR2013-001150-10-GB
• Date of registration: 25/07/2013
• Prospective Registration: Yes
• Primary sponsor: Alexion Pharmaceuticals, Inc.
• Public title: STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS
• Scientific title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)
• Date of first enrolment: 18/02/2014
• Target sample size: 132
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001150-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• 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, Peru, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, 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
- Diagnosis of NMO or NMO spectrum disorder
- NMO-IgG seropositive
- Historical Relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months, with at least 1 relapse in the 12 months prior to the Screening
- EDSS score =7
- Immunosuppressive therapy is allowed provided patients have been on a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study
- Patients must be willing and able to give 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:
- Use of rituximab or mitoxantrone within 3 months prior to Screening
- Use of IVIg within 3 weeks prior to screening



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

Health Condition(s) or Problem(s) studied

Neuromyelitis Optica
MedDRA version: 19.0 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-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: Efficacy of eculizumab treatment as compared with placebo in relapsing NMO patients based on the time to first relapse and relapse risk reduction.

Secondary Objective: - Safety and tolerability of eculizumab compared with placebo
- Efficacy of eculizumab compared with placebo
- Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab

Timepoint(s) of evaluation of this end point: Relapse evaluation visits:
- Within 24/48 hours after relapse
- Week +1 after relapse
- Week +4 after relapse
- Week +6 after relapse

Completion of the trial after 24 adjudicated On-Trial Relapse events in 24 distinct patients.

Primary end point(s): Time to first adjudicated On-Trial Relapse

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: evaluation at:
- Screening visit
- Weeks 1, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 104
- Relapse evaluation visits
- End of trial visit

Secondary end point(s): - Change from baseline in EDSS score at the End of Study Period
- Adjudicated annualized relapse rate
- Change from baseline in EQ-5D at the End of the Study Period
- Change from baseline in modified Rankin Scale (mRS) score at the End of the Study Period
- Change from baseline in ambulatory function as measured by Hauser Ambulation Index at the End of the Study Period.

Secondary ID(s)

2013-001150-10-DE

ECU-NMO-301

NCT01892345

Source(s) of Monetary Support

ALEXION PHARMACEUTICALS INC

Ethics review

Status: Approved
Approval date: 18/02/2014
Contact:

Results

• Results available: Yes
• Date Posted: 21/06/2019
• Date Completed: 17/07/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001150-10/results