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Replacement Therapy

Mim8 for Hemophilia A

Phase 3

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Applicable to participants treated with on-demand/no prophylaxis prior to enrolment: ≥5 bleeds in the last 26 weeks prior to screening visit, for which factor VIII concentrates or bypassing agent has been prescribed

Male or female participants with diagnosis of congenital haemophilia A of any severity based on medical records

Timeline

Screening 3 weeks

Treatment Varies

Follow Up no prophylaxis treatment (arms 1, 2a and 2b): from randomisation (week 0) to end of main (week 26) prophylaxis treatment (arms 3 and 4): from initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

Awards & highlights

Study Summary

This trial is investigating whether a new medicine, Mim8, works compared to other medicines in people with haemophilia A.

Who is the study for?

Adults and adolescents with Hemophilia A, either with or without inhibitors, can join this trial. They must have had treatment for Hemophilia A in the last 26 weeks and weigh at least 30 kg. Participants should be over 12 years old and willing to follow study procedures. Pregnant women, those on certain other treatments, or with conditions that could affect safety are not eligible.Check my eligibility

What is being tested?

The trial is testing Mim8, a new medicine designed to prevent bleeding by replacing clotting factor VIII (FVIII). It's given as an injection into the stomach skinfold weekly or monthly. The study compares Mim8's effectiveness against other treatments over a period of up to 29 months.See study design

What are the potential side effects?

While specific side effects of Mim8 aren't listed here, common side effects for hemophilia treatments include reactions at the injection site, potential development of inhibitors to the treatment itself leading to reduced effectiveness, allergic reactions, and increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had 5 or more bleeding episodes treated with specific medication in the last 6 months.

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I have been diagnosed with congenital haemophilia A.

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I am 12 years old or older.

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I have had at least one bleeding episode in the last 6 months that required treatment.

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My body weight is at least 30 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ no prophylaxis treatment (arms 1, 2a and 2b): from randomisation (week 0) to end of main (week 26) prophylaxis treatment (arms 3 and 4): from initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~no prophylaxis treatment (arms 1, 2a and 2b): from randomisation (week 0) to end of main (week 26) prophylaxis treatment (arms 3 and 4): from initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26)

This trial's timeline: 3 weeks for screening, Varies for treatment, and no prophylaxis treatment (arms 1, 2a and 2b): from randomisation (week 0) to end of main (week 26) prophylaxis treatment (arms 3 and 4): from initiation of run-in (26-52 weeks prior to week 0) to week 0 and from week 0 to end of main (week 26) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of treated bleeds

Secondary outcome measures

Change in patient's joint pain score using Joint Pain Rating Scale

Change in patient's treatment burden using the Hemo-TEM (haemophilia treatment experience measure)

Change in physical function domain of PEDS-QL (pediatric quality of life inventory)

+7 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: no PPX- no PPX - Mim8 PPXQW/QMExperimental Treatment1 Intervention

Participants not receiving prophylaxis will not enter the run-in period. In arm 1, participants will be randomised to continue no prophylaxis (on-demand treatment with their Standard of Care products) or Mim8 once-weekly or once-monthly prophylaxis in agreement with investigators in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) in agreement with the investigator, either weekly or monthly Mim8 prophylaxis regimen.

Group II: no PPX - Mim8 PPXQW - Mim8 PPXQWExperimental Treatment1 Intervention

Participants not receiving prophylaxis will not enter the run-in period. In arm 2a, participants will be randomised to Mim8 once-weekly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.

Group III: no PPX - Mim8 PPXQM - Mim8 PPXQMExperimental Treatment1 Intervention

Participants not receiving prophylaxis will not enter the run-in period. In arm 2b, participants will be randomised to Mim8 once-monthly prophylaxis in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthy Mim8 prophylaxis regimen.

Group IV: PPX- Mim8 PPXQMExperimental Treatment1 Intervention

Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 4, participants will be randomised to once-monthly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-monthly Mim8 prophylaxis regimen.

Group V: PPX - Mim8 PPXQWExperimental Treatment1 Intervention

Participants on coagulation factor prophylaxis prior to enrolment will preferably continue the same product type and dosing frequency in the run-in period for at least 26 weeks before they can be randomised into the main part of the study. These participants will only be allowed to receive coagulation factor prophylaxis. In arm 3, participants will be randomised to once-weekly Mim8 prophylaxis regimen in the main part of the study (26 weeks). After the main part, participants will continue in the extension part of the study (26 weeks) on once-weekly Mim8 prophylaxis regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NNC0365-3769 (Mim8)

2020

Completed Phase 2

~480

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,515 Previous Clinical Trials

2,415,092 Total Patients Enrolled

98 Trials studying Hemophilia A

10,238 Patients Enrolled for Hemophilia A

Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S

56 Previous Clinical Trials

44,853 Total Patients Enrolled

2 Trials studying Hemophilia A

102 Patients Enrolled for Hemophilia A

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

107 Previous Clinical Trials

139,850 Total Patients Enrolled

4 Trials studying Hemophilia A

413 Patients Enrolled for Hemophilia A

Media Library

Mim8 (Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05053139 — Phase 3

Hemophilia A Research Study Groups: PPX- Mim8 PPXQM, PPX - Mim8 PPXQW, no PPX- no PPX - Mim8 PPXQW/QM, no PPX - Mim8 PPXQW - Mim8 PPXQW, no PPX - Mim8 PPXQM - Mim8 PPXQM

Hemophilia A Clinical Trial 2023: Mim8 Highlights & Side Effects. Trial Name: NCT05053139 — Phase 3

Mim8 (Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053139 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial widely available to Canadian patients?

"To make participation more convenient for patients, this clinical trial is enrolling at 21 sites located across Ann Arbor, Omaha, New Orleans and other cities."

Answered by AI

How many people are eligible to participate in this experiment?

"That is correct, the trial is ongoing and currently recruiting patients. According to information on clinicaltrials.gov, the study was originally posted on December 2nd 2021 and last updated November 10th 2022. There are 21 sites enrolling a total of 267 participants."

Answered by AI

Are we still enrolling participants for this research project?

"That is accurate. The website clinicaltrials.gov contains information revealing that this trial is looking for 267 individuals from 21 different locations. This study was originally posted on December 2, 2021 and updated November 10, 2022."

Answered by AI