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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 14 October 2024
Main ID:  EUCTR2017-002370-39-IT
Date of registration: 18/01/2021
Prospective Registration: No
Primary sponsor: ALEXION PHARMACEUTICALS INCORPORATED
Public title: This study compares the pharmacokinetics (PK) of ravulizumab subcutaneous (SC) administered via an on-body delivery system (OBDS) to ravulizumab intravenous (IV) in patients with paroxysmal nocturnal hemoglobinuria (PNH) currently treated With Eculizumab.
Scientific title: A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab. - NA
Date of first enrolment: 21/02/2019
Target sample size: 105
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002370-39
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Patients in the ravulizumab IV group will switch to 490 mg of ravulizumab SC in the extension period If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Same drug, different pharmaceutical form. 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
Australia Austria Belgium Brazil Canada Czech Republic Czechia Finland
France Germany Italy Korea, Republic of Netherlands Russian Federation Spain Sweden
Turkey United Kingdom United States
Contacts
Name: European Clinical Trial Information   
Address:  1-15 Avenue Edouard Belin 92500 Rueil-Malmaison France
Telephone: 0033147100611
Email: clinicaltrials.eu@alexion.com
Affiliation:  Alexion Europe SAS
Name: European Clinical Trial Information   
Address:  1-15 Avenue Edouard Belin 92500 Rueil-Malmaison France
Telephone: 0033147100611
Email: clinicaltrials.eu@alexion.com
Affiliation:  Alexion Europe SAS
Key inclusion & exclusion criteria
Inclusion criteria:
Age
1. Patients must be at least 18 years of age at the time of signing the
informed consent.

Patient and Disease Characteristics
2. Treated with eculizumab according to the labeled dosing
recommendation for PNH (900 mg every 14 days ± 2 days) for at least 6
months prior to study entry with no missed doses within 2 months prior
to study entry and no more than 2 doses outside of the visit window.
3. Lactate dehydrogenase levels = 1.5 × ULN (upper limit of normal),
according to central laboratory, at Screening. Sample must be obtained
within 24 hours of or immediately prior to a scheduled eculizumab dose
administration (ie, at trough eculizumab level).
4. Documented diagnosis of PNH confirmed by high-sensitivity flow
cytometry evaluation (Borowitz, Craig et al. 2010).
5. Vaccinated against meningococcal infections within 3 years prior to,
or at the time of, initiating study drug to reduce the risk of
meningococcal infection (N meningitidis).
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
Medical Conditions
1. More than 1 LDH value > 2 × ULN within the 6 months prior to study
entry.
2. Major adverse vascular event (MAVE) in the 6 months prior to study
entry.
3. Platelet count < 30,000/mm3 (30 × 109/L) at Screening.
4. Absolute neutrophil count < 500/µL (0.5 × 109/L) at Screening.
5. History of bone marrow transplantation.
6. History of N meningitidis infection.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1 Level: LLT Classification code 10055629 Term: Paroxysmal nocturnal hemoglobinuria System Organ Class: 100000004857
Intervention(s)

Trade Name: NA
Product Name: Ravulizumab
Product Code: [ALXN1210]
Pharmaceutical Form: Solution for injection
Current Sponsor code: ALXN1210
Other descriptive name: Ravulizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-

Trade Name: NA
Product Name: Ravulizumab
Product Code: [ALXN1210]
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: ALXN1210
Other descriptive name: Ravulizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: To evaluate PK noninferiority of ravulizumab SC versus ravulizumab IV in adult patients with PNH.
Primary end point(s): Day 71 serum ravulizumab Ctrough
Secondary Objective: - To characterize PK of ravulizumab SC
- To characterize PD of ravulizumab SC
- To characterize immunogenicity of ravulizumab SC
- To evaluate HRQoL and treatment satisfaction on ravulizumab SC
- To evaluate safety of ravulizumab SC and ravulizumab OBDS
- To evaluate efficacy of ravulizumab SC
- To assess performance of ravulizumab OBDS
Timepoint(s) of evaluation of this end point: Day 71
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Throughout the study
Secondary end point(s): - PK Endpoint: Ctrough over time
- PD Endpoint: Free serum C5 concentrations over time
- Immunogenicity
- HRQoL and Treatment Satisfaction Endpoints
- Safety Endpoints
- Efficacy Endpoints
Secondary ID(s)
128367
2017-002370-39-DE
ALXN1210-PNH-303
Source(s) of Monetary Support
Alexion Pharmaceuticals, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 18/02/2019
Contact:
Results
Results available: Yes
Date Posted: 25/08/2022
Date Completed:
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-002370-39/results
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