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A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5) (FRONTIER 5)

Primary Purpose

Haemophilia A, Haemophilia A With Inhibitors

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NNC0365-3769 (Mim8) PPX
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records. Age 12 years or above at the time of signing the informed consent. Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W), or once every four weeks (Q4W) according to the label for at least 8 weeks prior to screening. Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2). Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires. Exclusion Criteria: Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening. Any disorder, which in the investigator's opinion might jeopardise the participant's compliance with the protocol or safety, including ongoing Adverse Events (AEs) associated with emicizumab. Previous participation in this study. Participation is defined as signed informed consent. Known congenital or acquired coagulation disorders other than haemophilia A. Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator. Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments. Receipt of FVIII gene therapy at any time. Ongoing or planned immune tolerance induction therapy. Minor or major surgery planned to take place after screening and during the 26-week treatment period. Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than (>) 3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening. Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser than or equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) for serum creatinine measured at screening. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NNC0365-3769 (Mim8) PPX

Arm Description

Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector.

Outcomes

Primary Outcome Measures

Number of treatment-emergent adverse events
Measured as count of events.

Secondary Outcome Measures

Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
Measured as percentage of participants. HDHPA measures device handling experience and device preference. The measure consists of 26 items that are reported individually. it is measures in units: Percentage of participants = the distribution of participant answers within each response category, for each of the 26 individual items.
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
Measured as score points. Hemo-TEM measures treatment burden. The measure consists of 26 items yielding 5 domain scores and 1 total score. Domain scores (score range): Injection difficulties (0-100), physical impact (0-100), treatment bother (0-100), interference with daily life (0-100), and emotional impact (0-100). Total score ranges 0-100. Higher scores indicate greater treatment burden.

Full Information

First Posted
May 12, 2023
Last Updated
October 11, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05878938
Brief Title
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)
Acronym
FRONTIER 5
Official Title
Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
January 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia A, Haemophilia A With Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NNC0365-3769 (Mim8) PPX
Arm Type
Experimental
Arm Description
Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector.
Intervention Type
Drug
Intervention Name(s)
NNC0365-3769 (Mim8) PPX
Intervention Description
Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks.
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events
Description
Measured as count of events.
Time Frame
From Visit 2 (week 0) until week 26
Secondary Outcome Measure Information:
Title
Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
Description
Measured as percentage of participants. HDHPA measures device handling experience and device preference. The measure consists of 26 items that are reported individually. it is measures in units: Percentage of participants = the distribution of participant answers within each response category, for each of the 26 individual items.
Time Frame
Visit 8 (after 26 weeks of treatment)
Title
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
Description
Measured as score points. Hemo-TEM measures treatment burden. The measure consists of 26 items yielding 5 domain scores and 1 total score. Domain scores (score range): Injection difficulties (0-100), physical impact (0-100), treatment bother (0-100), interference with daily life (0-100), and emotional impact (0-100). Total score ranges 0-100. Higher scores indicate greater treatment burden.
Time Frame
From Visit 2 (week 0) until end of treatment (up to 26 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female with diagnosis of congenital haemophilia A of any severity based on medical records. Age 12 years or above at the time of signing the informed consent. Participants treated with emicizumab once-weekly (QW), once every two weeks (Q2W), or once every four weeks (Q4W) according to the label for at least 8 weeks prior to screening. Participants choosing to discontinue emicizumab treatment and switch to Mim8 QW, Q2W, or once-monthly (QM) treatment for 26 weeks from start of treatment (Visit 2). Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires. Exclusion Criteria: Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening. Any disorder, which in the investigator's opinion might jeopardise the participant's compliance with the protocol or safety, including ongoing Adverse Events (AEs) associated with emicizumab. Previous participation in this study. Participation is defined as signed informed consent. Known congenital or acquired coagulation disorders other than haemophilia A. Previous or current thromboembolic disease or events (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator. Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments. Receipt of FVIII gene therapy at any time. Ongoing or planned immune tolerance induction therapy. Minor or major surgery planned to take place after screening and during the 26-week treatment period. Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than (>) 3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening. Renal impairment defined as estimated glomerular filtration rate (eGFR) lesser than or equal to (≤) 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) for serum creatinine measured at screening. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Innsbruck
ZIP/Postal Code
A 6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bron Cedex
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Parktown, Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT9 78B
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)

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