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Monoclonal Antibodies

Concizumab for Hemophilia (explorer7 Trial)

Phase 3

Waitlist Available

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

Male aged 12 years or older at the time of signing informed consent.

Congenital Haemophilia A or B of any severity with documented history of inhibitor (equal to or above 0.6 Bethesda Units (BU)).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on demand (arm 1): from randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) concizumab (arm 2): from start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)

Awards & highlights

explorer7 Trial Summary

This trial will test how well a new medicine, concizumab, works in the bodies of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use.

Who is the study for?

This trial is for males aged 12 or older with Hemophilia A or B and inhibitors, who have used bypassing agents in the last 24 weeks. It's not for those with thromboembolic disease, high risk of blood clots, ongoing immune treatments, hypersensitivity to similar drugs, or other coagulation disorders.Check my eligibility

What is being tested?

The study tests concizumab's effectiveness in preventing bleeds in people with hemophilia on-demand or prophylaxis treatment. Participants self-inject daily using a pen-injector and are monitored over six years with clinic visits and an electronic diary.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions due to concizumab throughout the study period.

explorer7 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am a male aged 12 or older.

Select...

I have Haemophilia A or B with a history of inhibitors.

explorer7 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on demand (arm 1): from randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) concizumab (arm 2): from start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on demand (arm 1): from randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) concizumab (arm 2): from start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and on demand (arm 1): from randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) concizumab (arm 2): from start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The number of treated spontaneous and traumatic bleeding episodes

Secondary outcome measures

Area under the concizumab plasma concentration-time curve (AUC)

Change in 36 Item short form health survey version 2 (SF36v2) bodily pain

Change in SF36v2 physical functioning

+11 more

Side effects data

From 2020 Phase 2 trial • 36 Patients • NCT03196297

14%

Arthralgia

14%

Upper respiratory tract infection

14%

Pyrexia

14%

Back pain

14%

Fall

Presyncope

Angioedema

Musculoskeletal pain

Influenza

Ligament sprain

Antithrombin III decreased

Basophil count increased

Dental caries

Fibrin D dimer increased

Gastroenteritis viral

Headache

Hepatic enzyme increased

Injection site haemorrhage

Myalgia

Nasopharyngitis

Prothrombin fragment 1.2 increased

Radius fracture

Soluble fibrin monomer complex increased

Tooth abscess

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Concizumab 0.20 mg/kg - Extension Part

Concizumab 0.20 mg/kg - Main Part

Concizumab 0.15 mg/kg - Extension Part

Concizumab 0.25 mg/kg - Extension Part

Concizumab 0.25 mg/kg - Main Part

Concizumab 0.15 mg/kg - Main Part

explorer7 Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4: Concizumab prophylaxisExperimental Treatment1 Intervention

Patients previously on prophylaxis with by-passing agents and on-demand patients who are screened at a timepoint where the required number of patients in arms 1 and 2 have been randomised. These patients will, if eligible, be enrolled into the trial and will initiate concizumab prophylaxis at visit 2a (week 0).

Group II: Arm 3: Concizumab prophylaxisExperimental Treatment1 Intervention

The HAwI and HBwI patients enrolled into the concizumab phase 2 trial (NN7415-4310) at time of transfer will be offered enrolment into this trial. It is required that these patients are on concizumab prophylaxis up until enrolment into the trial. These patients will continue concizumab prophylaxis.

Group III: Arm 2: Concizumab prophylaxisExperimental Treatment1 Intervention

HAwI and HBwI patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.

Group IV: Arm 1: No prophylaxisExperimental Treatment1 Intervention

Haemophilia A with inhibitors (HAwI) and haemophilia B with inhibitors (HBwI) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension part, patients in arm 1 will receive daily concizumab subcutaneous (s.c., under the skin) injections.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Concizumab

2023

Completed Phase 2

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,513 Previous Clinical Trials

2,414,893 Total Patients Enrolled

54 Trials studying Hemophilia B

6,870 Patients Enrolled for Hemophilia B

Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S

104 Previous Clinical Trials

103,118 Total Patients Enrolled

5 Trials studying Hemophilia B

1,022 Patients Enrolled for Hemophilia B

Media Library

Concizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04083781 — Phase 3

Hemophilia B Research Study Groups: Arm 1: No prophylaxis, Arm 2: Concizumab prophylaxis, Arm 4: Concizumab prophylaxis, Arm 3: Concizumab prophylaxis

Hemophilia B Clinical Trial 2023: Concizumab Highlights & Side Effects. Trial Name: NCT04083781 — Phase 3

Concizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083781 — Phase 3

Frequently Asked Questions

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

Are there any available positions for patients in this research?

"As of now, this study is no longer recruiting patients. If you check the date of the last edit on the trial's page, you will see that it was updated on October 27th, 2022. There are currently 91 other trials seeking participants who have hemophilia b with inhibitors and 3 studies for Concizumab are also open."

Answered by AI

Is this a new clinical trial?

"Concizumab has a relatively short history, with the first trials being performed in 2019. These initial tests were sponsored by Novo Nordisk A/S and involved 136 individuals. Phase 3 approval was granted after these successful 2019 trials. At present, there are three ongoing Concizumab clinical trials taking place in 42 cities across 39 countries."

Answered by AI

What are the potential dangers associated with Concizumab?

"Concizumab's safety is estimated to be a 3. This rating comes from the fact that it is a Phase 3 trial, so while there isn't extensive data supporting its efficacy, there are multiple rounds of data indicating that it is safe."

Answered by AI

How many individuals are included in this research project?

"Unfortunately, this study is not currently enrolling patients. Although, it's worth noting that the posting date was October 21st 2019 and the last update was on October 27th 2022. For other trials, there are 91 studies actively recruiting patients with hemophilia b with inhibitors and 3 trials for Concizumab actively recruiting patients."

Answered by AI

Are there any other clinics in Canada conducting this same clinical trial?

"Enrolling patients are currently being recruited from 8 different locations, which include San Antonio, Atlanta, and Orange. If you're interested in enrolling, it's recommended that you choose the closest location to reduce travel time and expenses."

Answered by AI

What other studies have been done that focus on Concizumab?

"The first trial for concizumab was at Novo Nordisk Investigational Site in 2019. So far, 3 trials have completed and there are 3 more active studies. A considerable amount of these ongoing experiments are taking place out of San Antonio, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

2019. "Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083781.

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