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Monoclonal Antibodies

Concizumab for Hemophilia (explorer8 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on demand (arm 1): from randomisation after the pause (wk 0) up until start of concizumab treatment (wk 24). concizumab (arm 2): from start of the new concizumab dosing regimen (wk 0) up until the confirmatory analyses cut-off (at least 32 weeks)

Awards & highlights

explorer8 Trial Summary

This trial is testing a new medicine for hemophilia A or B, to see if it can prevent bleeds and is safe to use. Participants who only use medicine to treat bleeds on-demand will be in one of two groups- one group will receive the study medicine from the start, and the other group will continue with their normal medicine and receive the study medicine after 6 months. The study will last for approximately three years, and participants will have to come to the clinic for up to 33 visits.

Who is the study for?

This trial is for males aged 12 or older with severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%), without inhibitors. Participants must consent and be able to inject themselves daily with the study drug, concizumab. They cannot join if they have other coagulation disorders, a history of blood clots, are at high risk for clotting events, or are allergic to ingredients in the trial product.Check my eligibility

What is being tested?

The effectiveness of concizumab in preventing bleeds in people with haemophilia A or B is being tested. Some participants will start on concizumab immediately while others will begin after six months; assignment is random. Those already on prophylaxis treatment will receive it from the start. The medicine is self-administered daily via a pen-injector.See study design

What are the potential side effects?

Potential side effects of concizumab may include reactions at the injection site, increased risk of bleeding episodes due to its blood-thinning properties, and possible allergic reactions among those sensitive to its components.

explorer8 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.

explorer8 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame is presented under 'outcome measure description'

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame is presented under 'outcome measure description'

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame is presented under 'outcome measure description' for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

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

Hemophilia A

For haemophilia A patients without inhibitors: Number of treated spontaneous and traumatic target joint bleeds

+14 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

explorer8 Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 4: Concizumab prophylaxisExperimental Treatment1 Intervention

Arm 4 will include patients previously on prophylaxis with factor products with a minimum of 24 weeks observation in NN7415-4322 (explorer 6) (at least 30 HA and 30 HB patients). In addition, arm 4 will also include: 1) Patients who were randomised to arms 1 and 2 before the treatment pause. 2) HA patients who were in NN7415-4255 (explorer 5) at the time of the treatment pause, and who have now completed explorer 5. 3) On demand patients included after arms 1 and 2 are closed.

Group II: Arm 3: Concizumab prophylaxisExperimental Treatment1 Intervention

The HA patients enrolled into the concizumab phase 2 trial NN7415-4255 (explorer 5) will be offered enrolment into this arm.

Group III: Arm 2: Concizumab prophylaxisExperimental Treatment1 Intervention

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

Group IV: Arm 1: No prophylaxis (PPX)Experimental Treatment1 Intervention

Haemophilia A (HA) and haemophilia B (HB) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension phase, this group will receive treatment with concizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Concizumab

2023

Completed Phase 2

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,513 Previous Clinical Trials

2,414,871 Total Patients Enrolled

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

104 Previous Clinical Trials

103,096 Total Patients Enrolled

Media Library

Concizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04082429 — Phase 3

Haemophilia A Research Study Groups: Arm 3: Concizumab prophylaxis, Arm 4: Concizumab prophylaxis, Arm 1: No prophylaxis (PPX), Arm 2: Concizumab prophylaxis

Haemophilia A Clinical Trial 2023: Concizumab Highlights & Side Effects. Trial Name: NCT04082429 — Phase 3

Concizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082429 — Phase 3

Frequently Asked Questions

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

Are we enrolling patients for this experiment right now?

"According to the listing on clinicaltrials.gov, this study is not currently enrolling new patients. This trial was initially posted on November 13th, 2019 but was edited most recently on September 20th, 2022. There are, however, 94 other trials that are actively looking for new participants."

Answered by AI

Has Concizumab been cleared by the FDA for medical use?

"Concizumab's safety is supported by multiple rounds of data, as is typical of a Phase 3 trial. Therefore, it received a score of 3."

Answered by AI

Is this the inaugural clinical trial testing this treatment?

"Concizumab has been the focus of medical research since 2019. Novo Nordisk A/S sponsored the first trial in 2019, which resulted in the drug's Phase 3 approval. As of now, there are 3 active trials in 31 different cities and 36 countries."

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 Without Inhibitors

2019. "Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04082429.

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