A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

• Register: EUCTR
• Last refreshed on: 12 April 2021
• Main ID: EUCTR2014-000253-36-GR
• Date of registration: 30/01/2017
• Prospective Registration: Yes
• Primary sponsor: MedImmune LLC
• Public title: A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
• Scientific title: A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD
• Date of first enrolment: 31/03/2017
• Target sample size: 212
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000253-36
• 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: yes; Other trial design description: Open label extension; 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): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Germany, Greece, Hong Kong, Hungary, Israel, Japan, Korea, Republic of, Mexico, Moldova, Republic of, Netherlands, New Zealand, Peru, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Information Center
• Affiliation: MedImmune LLC

• Name: Information Center
• Affiliation: MedImmune LLC

Key inclusion & exclusion criteria

Inclusion criteria:
1) Men and women 18 years or older with diagnosis of NMO/NMOSD.
2) Confirmation of NMO/NMOSD status:
a.) AQP4-IgG sero-positive NMO/NMOSD with at least one attack requiring rescue
therapy in the last year or two attacks requiring rescue therapy in the last 2 years.
b.) AQP4-IgG sero-negative NMO with at least one attack requiring rescue therapy in the
last year or two attacks requiring rescue therapy in the last 2 years.
3) Able and willing to give written informed consent and comply with the requirements of the study protocol.
4) EDSS <= 7.5 (8 in special circumstances).
5) Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.


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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
1) Lactating and pregnant females.
2) Treatment with any investigational agent within 4 weeks of screening.
3) Known history of a severe allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy.
4) Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization.
5) History of of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to randomization.
6) Receipt of the following at any time prior to randomization:
a) Alemtuzumab
b) Total lymphoid irradiation
c) Bone marrow transplant
d) T-cell vaccination therapy
7) Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
8) Receipt of IVIG within 1 month prior to randomization.
9) Receipt of any of the following within 3 months prior to randomization:
a) Natalizumab (Tysabri®)
b) Cyclosporin
c) Methotrexate
d) Mitoxantrone
e) Cyclophosphamide
f) Tocilizumab
g) Eculizumab
10) History of Hepatitis B and/or Hepatitis C (Hep B/C at screening).
11) Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection.
12) History of malignancies, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to randomization.
13) Any concomitant disease other than NMO/NMOSD that required treatment with oral or intravenous steroids at doses over 20 mg a day for over 21 days.


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

Health Condition(s) or Problem(s) studied

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

Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 19.1 Level: LLT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 100000004852

Intervention(s)

Product Name: MEDI-551
Product Code: MEDI-551
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: 1299440-37-1
Current Sponsor code: MEDI-551
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Time to an NMO/NMOSD attack determined by Adjudication Committee in randomized-control period

Timepoint(s) of evaluation of this end point: on or before Day 197

Main Objective: To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack

Secondary Objective: 1. To characterize the long-term efficacy of MEDI-551 by means of annualized attack rate.
2. To evaluate the safety and tolerability of MEDI-551
3. To characterize the pharmacokinetic (PK) profile and immunogenicity of MEDI-551

Secondary Outcome(s)

Secondary end point(s): 1. To characterize the long-term efficacy of MEDI-551 by means of annualized attack rate.
2. To evaluate the safety and tolerability of MEDI-551
3. To characterize the pharmacokinetic (PK) profile and immunogenicity of MEDI-551

Timepoint(s) of evaluation of this end point: End of Randomized-controlled Period and End of Study

Secondary ID(s)

NCT02200770

2014-000253-36-CZ

CD-IA-MEDI-551-1155

Source(s) of Monetary Support

MedImmune LLC

Ethics review

Status: Approved
Approval date: 31/03/2017
Contact: