Study of mepolizumab in patients with HES from Study 200622

• Register: EUCTR
• Last refreshed on: 10 August 2020
• Main ID: EUCTR2017-000184-32-BE
• Date of registration: 03/07/2017
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research & Development Ltd
• Public title: Study of mepolizumab in patients with HES from Study 200622
• Scientific title: A multi-centre, open-label extension, safety study to describe the longterm clinical experience of mepolizumab in participants with hypereosinophilic syndrome (HES) from Study 200622 - A multi-centre, open-label, long term safety study of mepolizumab in subjects with HES.
• Date of first enrolment: 29/08/2017
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000184-32
• 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, Belgium, Brazil, France, Germany, Mexico, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: GSK Clinical Support Help Desk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: GSK Clinical Support Help Desk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Study 200622 requirements
1. Age 12 years and older participants who were enrolled in Study 200622.
To be considered for Study 205203, Study 200622 participants must have completed 32-week assessments since randomization:
(i) Completion of the 32-week treatment period in Study 200622
OR
(ii) If the participant was withdrawn from study treatment prematurely during the 200622 study, but continued in the study per protocol(including HES flare related assessments) until 32 weeks from randomization.
Sex
2. Male or female
Female participants:
A female participant who meets one of the following conditions:
(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5
OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 at least 30 days prior to the first dose of study treatment and until 16 weeks after the last dose of study treatment.

Positive benefit: risk ratio
3. The treating physician must confirm a positive benefit/risk ratio. The anticipated clinical benefit from mepolizumab must outweigh any potential safety or tolerability risk in Study 205203.

Informed consent
4. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
1. Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab)
2. Participants with current malignancy or malignancy that developed during Study 200622.
NOTE:
Participants who had localized localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
3. Participant who is pregnant or breastfeeding.
NOTE:
Participants should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
4. Participant who has other clinically significant medical conditions uncontrolled with SoC therapy not associated with HES, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease.
NOTE:
-Participants with recent parasitic (helminth) infections will be excluded from the study or required to be adequately treated for helminth infections before initiation of mepolizumab.
5. Participants with QTc >450 msec or QTc > 480 msec in participants with bundle branch block based on local EGC reading
NOTES:
-The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machine-read or manually over-read.
- The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.

6. Liver abnormality/disease:
- Participants who discontinue study treatment based on liver chemistry stopping
criteria during Study 200622
-Current active liver or biliary disease (with the exception of Gilbert’s syndrome
or asymptomatic gallstones or otherwise stable chronic liver disease per
investigator assessment).
NOTE: Stable chronic liver disease should generally be defined by the absence
of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or
gastric varices, or persistent jaundice, or cirrhosis.

Prior/concurrent clinical study experience

7. Other investigational product/clinical study:
-Participants who have received treatment with an investigational agent (biologic
or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer,
prior to the first dose, other than Study 200622 study treatment. The term “investigational” applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or
investigational formulations of marketed products
-Participants who are currently participating in any other interventional clinical
study

8. Participant had an adverse event (serious or non-serious) considered related to study treatment while participating in Study 200622 which resulted in permanent withdrawal of study treatment.


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

Health Condition(s) or Problem(s) studied

Hypereosinophilic syndrome (HES)
MedDRA version: 20.0 Level: PT Classification code 10048643 Term: Hypereosinophilic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Trade Name: Nucala
Product Name: Nucala
Product Code: SB240563
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: MEPOLIZUMAB
CAS Number: 196078-29-2
Current Sponsor code: SB240563
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To describe the long-term safety profile of mepolizumab in participants with HES who took part in Study 200622.

Secondary Objective: Not Applicable

Timepoint(s) of evaluation of this end point: During 20 weeks starting randomization

Primary end point(s): • Adverse events (AEs) [serious and non- serious]
• Anti-drug antibody

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): No secondary endpoints

Secondary ID(s)

205203

2017-000184-32-DE

Source(s) of Monetary Support

GlaxoSmithKline Research & Development Ltd

Ethics review

Status: Approved
Approval date: 29/08/2017
Contact:

Results

• Results available: Yes
• Date Posted: 20/06/2020
• Date Completed: 30/12/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000184-32/results