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Monoclonal Antibodies

Concizumab for Hemophilia A and B (Explorer10 Trial)

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

Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX (coagulation factor IX) below or equal to 2%), or congenital haemophilia with inhibitors

For arm 1 only: Patients without inhibitors (haemophilia A or haemophilia B)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 0 to 24 hours where 0 is the time of the concizumab dose at week 20

Awards & highlights

Explorer10 Trial Summary

This trialwill test a new medicine to prevent bleeds in people with haemophilia A or B, who will take it by injection every day for two years.

Who is the study for?

This trial is for individuals with severe haemophilia A or moderate/severe haemophilia B, with or without inhibitors. Participants must have a history of treatment for at least 26 weeks in the past year and give informed consent. It's not open to those allergic to concizumab, undergoing Immune Tolerance Induction, with thromboembolic disease or risk factors for it, other coagulation disorders besides haemophilia, or a history of thrombosis.Check my eligibility

What is being tested?

The study tests concizumab's effectiveness in preventing bleeding episodes in people with haemophilia A/B. Participants will self-inject concizumab daily using a pen-injector. The trial spans 2-4 years depending on when the drug becomes commercially available.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include reactions similar to other injectable medications used in hemophilia such as injection site reactions, potential allergic responses, and risks associated with altering blood clotting.

Explorer10 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have severe haemophilia A, moderate/severe haemophilia B, or haemophilia with inhibitors.

Select...

I have haemophilia A or B without inhibitors.

Select...

I have been on preventive treatment for at least 26 weeks in the past year.

Select...

I have haemophilia B with inhibitors and have been treated on-demand for at least 26 weeks in the past year.

Select...

I've had at least 3 treated bleeds in the last year while on on-demand treatment.

Explorer10 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 to 24 hours where 0 is the time of the concizumab dose at week 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 to 24 hours where 0 is the time of the concizumab dose at week 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 24 hours where 0 is the time of the concizumab dose at week 20 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

For inhibitor patients with at least 26 weeks on-demand treatment during the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes

For non-inhibitor patients treated on demand during at least the last 52 weeks prior enrolment: Number of treated spontaneous and traumatic bleeding episodes

Secondary outcome measures

Area under the concizumab plasma concentration-time curve (AUC), reported both separately for inhibitor and non-inhibitor patients and combined

Concizumab plasma concentrations prior to dosing, reported both separately for inhibitor and non-inhibitor patients and combined

Concizumab-naïve pateints - Number of treatment emergent adverse events, reported both separately for inhibitor and non-inhibitor patients and combined

+22 more

Side effects data

From 2020 Phase 2 trial • 36 Patients • NCT03196297

13%

Fibrin D dimer increased

13%

Prothrombin level increased

Presyncope

Ligament sprain

Arthropathy

Diabetes mellitus

Pyrexia

Toothache

Otitis externa

Contusion

Haemophilic arthropathy

Headache

Injection site induration

Nasopharyngitis

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Concizumab 0.20 mg/kg - Main Part

Concizumab 0.20 mg/kg - Extension 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

Explorer10 Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients coming from compassionate useExperimental Treatment1 Intervention

Patients previously treated with concizumab via compassionate use, either on an individual patient basis or through the concizumab compassionate use programme NN7415-4807

Group II: Concizumab-naïve patientsExperimental Treatment1 Intervention

Concizumab-naïve participants below 12 years of age at the time of consent/assent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Concizumab

2023

Completed Phase 2

~110

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,978 Total Patients Enrolled

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

106 Previous Clinical Trials

139,736 Total Patients Enrolled

Media Library

Concizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05135559 — Phase 3

Haemophilia A and B Research Study Groups: Patients coming from compassionate use, Concizumab-naïve patients

Haemophilia A and B Clinical Trial 2023: Concizumab Highlights & Side Effects. Trial Name: NCT05135559 — Phase 3

Concizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135559 — 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 research project currently recruiting new participants?

"That is correct, the online information regarding this clinical trial says that it is recruiting. The posting date was March 24th, 2022 and the last update was on November 10th, 2022. They are looking for a total of 90 participants which will be collected from 12 different locations."

Answered by AI

What are the risks associated with taking Concizumab for those who have never tried it before?

"Concizumab-naïve patients are estimated to be a 3 on the Power team's safety scale. This is due to the fact that this is a Phase 3 trial, which provides some evidence of efficacy as well as multiple rounds of safety data."

Answered by AI

Has this research been previously conducted?

"To date, there have been 3 separate clinical trials testing Concizumab on patients who have never used the drug before. These studies took place across 42 cities and 39 countries, with the first one being conducted in 2019. The 2019 study was sponsored by Novo Nordisk A/S, had 136 participants, and reached Phase 3 approval."

Answered by AI

Are there any other research projects that look at the effects of Concizumab on patients who have never taken it before?

"Concizumab-naïve patients were first researched in 2019 at the Novo Nordisk Investigational Site. So far, there have been 3 clinical trials completed with more ongoing research being conducted as we speak. Presently, there are 3 studies looking for participants and many of them are based in Orlando, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

2022. "A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05135559.

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