A Phase 3 interventional study of Concizumab in Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S. Active, not recruiting at 99 sites in 29 countries. Open to male participants. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This study will test how well a new medicine called concizumab works in the body 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. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about seven years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (31 December 2026 at the latest). The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's enrollment of 134 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Concizumab
HAwI and HBwI patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.
Drug: Concizumab
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.
Drug: Concizumab
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).
Drug: Concizumab
Concizumab will be administered daily subcutaneously (s.c., under the skin). When patients are randomised to concizumab prophylaxis they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week 0: arm 2, 3 \& 4) or visit 9a (week 24: arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (week 6: arm 2, 3 \& 4) or 9a.3 (week 30: arm 1) and will be based on the concizumab exposure level measured at the previous visit 4a (week 4) or 9a.2 (week 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual bypassing product until visit 9a (week 24: end of main part for arm 1).
Rate of Treated Spontaneous and Traumatic Bleeding Episodes
Rate of treated spontaneous and traumatic bleeding episodes is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excl. data on initial regimen for participants exposed to both regimens (OTwoATexIR). It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of annualised bleeding rate (ABR). Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From week 0 up until the primary analysis cut-off (at least 32 weeks)
Rate of Treated Spontaneous Bleeding Episodes
Rate of treated spontaneous bleeding episodes is presented. The observation period used for reporting this endpoint is OTwoATexIR. It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Extension concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off Concizumab (arm 2): From week 0 up until week 56 cut-off
Rate of Treated Spontaneous and Traumatic Joint Bleeds
Rate of treated spontaneous and traumatic joint bleeds is presented. Observation period used for reporting this endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Extension concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off Concizumab (arm 2): From week 0 up until week 56 cut-off
Rate of Treated Spontaneous and Traumatic Target Joint Bleeds
Rate of treated spontaneous and traumatic target joint bleeds is presented. Observation period used for reporting the endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Time frame: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Extension concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off Concizumab (arm 2): From week 0 up until week 56 cut-off
Change in 36-item Short Form Health Survey (SF-36v2) Bodily Pain
Change in 36-item SF-36v2 bodily pain from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic patient-reported outcome (PRO) instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for bodily pain are 21.68 to 62.0. Higher values indicate better functional health and well-being. Observation period for reporting the data is on-treatment without data on initial regimen (OTexIR) which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.
Time frame: Baseline (week 0), Week 24
Change in SF36v2 Physical Functioning
Change in 36-item SF-36v2 physical functioning from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic PRO instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for physical functioning are 19.26 to 57.54. Higher values indicate better functional health and well-being. Observation period used for reporting the data is OTexIR which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.
Time frame: Baseline (week 0), Week 24
Number of Thromboembolic Events
Number of thromboembolic events is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: On demand (arm 1 ): From week 0 until start of concizumab treatment (atleast 24 weeks) Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off
Number of Thromboembolic Events
Number of thromboembolic events is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: From week 0 to end of trial (week 167)
Number of Hypersensitivity Type Reactions
Number of hypersensitivity type reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: On demand (arm 1 ): From week 0 until start of concizumab treatment (atleast 24 weeks) Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off
Number of Hypersensitivity Type Reactions
Number of hypersensitivity type reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: From week 0 to end of trial (week 167)
Number of Injection Site Reactions
Number of injection site reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: On demand (arm 1 ): From week 0 until start of concizumab treatment (atleast 24 weeks) Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off
Number of Injection Site Reactions
Number of injection site reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: From week 0 to end of trial (week 167)
Number of Participants With Antibodies to Concizumab
Number of participants with antibodies to concizumab is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off
Number of Participants With Antibodies to Concizumab
Number of participants with antibodies to concizumab is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Time frame: From week 0 to end of trial (week 167)
Pre-dose (Trough) Concizumab Plasma Concentration (Ctrough)
Pre-dose (trough) concizumab plasma concentration is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
Time frame: Pre-dose (prior to concizumab administration at week 56)
Pre-dose Thrombin Peak
Pre-dose thrombin peak for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
Time frame: Pre-dose (prior to concizumab administration at week 56)
Pre-dose Free Tissue Factor Pathway Inhibitor (TFPI) Concentration
Pre-dose free TFPI concentration for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
Time frame: Pre-dose (prior to concizumab administration at week 56)
Maximum Concizumab Plasma Concentration (Cmax)
Maximum concizumab plasma concentration is presented. The observation period used for reporting the endpoint is on OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
Time frame: Week 24: Predose, 3 hours (h), 6h, 9h, 24h
Area Under the Concizumab Plasma Concentration-time Curve (AUC)
Area under the concizumab plasma concentration-time curve is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
Time frame: Week 24: Predose, 3 hours (h), 6h, 9h, 24h
The trial was conducted in 27 countries. There were 70 sites that randomised participants. The details are as follows: Algeria (2), Australia (2), Austria (1), Bulgaria (1), Canada (0), Croatia (1), Czech Republic (1), Denmark (1), France (4), India (4), Italy (4), Japan (6), Republic of Korea (2), Malaysia (3), Mexico (1), Poland (4), Portugal (1), Russian Federation (5), Serbia (1), South Africa (2), Spain (5), Sweden (1), Thailand (3), Turkey (4), Ukraine (2), UK (3), United States (6).
| Milestone | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Started | 19 | 33 | 21 | 60 |
| Full analysis set (fas) | 19 | 33 | 21 | 60 |
| Safety analysis set (sas) | 19 | 33 | 21 | 60 |
| Completed | 13 | 27 | 15 | 53 |
| Not completed | 6 | 6 | 6 | 7 |
| Withdrew: Physician decision | 0 | 1 | 2 | 0 |
| Withdrew: Death | 1 | 3 | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 2 | 3 | 7 |
| Milestone | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Started | 13 | 27 | 15 | 53 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 13 | 27 | 15 | 53 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Ongoing | 13 | 25 | 15 | 51 |
Rate of treated spontaneous and traumatic bleeding episodes is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excl. data on initial regimen for participants exposed to both regimens (OTwoATexIR). It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of annualised bleeding rate (ABR). Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) |
|---|---|---|
| Rate of Treated Spontaneous and Traumatic Bleeding Episodes | 9.8 (6.5 to 20.2) | 0.0 (0.0 to 3.3) |
Rate of treated spontaneous bleeding episodes is presented. The observation period used for reporting this endpoint is OTwoATexIR. It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) |
|---|---|---|---|
| Rate of Treated Spontaneous Bleeding Episodes | 8.4 (3.9 to 14.3) | 0.0 (0.0 to 1.3) | 0.0 (0.0 to 2.2) |
Rate of treated spontaneous and traumatic joint bleeds is presented. Observation period used for reporting this endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) |
|---|---|---|---|
| Rate of Treated Spontaneous and Traumatic Joint Bleeds | 6.5 (3.2 to 13.1) | 1.3 (0.0 to 1.6) | 0.7 (0.0 to 2.8) |
Rate of treated spontaneous and traumatic target joint bleeds is presented. Observation period used for reporting the endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
| Events per year | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) |
|---|---|---|---|
| Rate of Treated Spontaneous and Traumatic Target Joint Bleeds | 0.0 (0.0 to 2.2) | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
Change in 36-item SF-36v2 bodily pain from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic patient-reported outcome (PRO) instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for bodily pain are 21.68 to 62.0. Higher values indicate better functional health and well-being. Observation period for reporting the data is on-treatment without data on initial regimen (OTexIR) which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.
| Score on a scale | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Change in 36-item Short Form Health Survey (SF-36v2) Bodily Pain | 3.2 ± 10.1 | 9.3 ± 9.2 | 4.3 ± 10.1 | 6.5 ± 10.0 |
Change in 36-item SF-36v2 physical functioning from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic PRO instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for physical functioning are 19.26 to 57.54. Higher values indicate better functional health and well-being. Observation period used for reporting the data is OTexIR which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.
| Score on a scale | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Change in SF36v2 Physical Functioning | 1.6 ± 10.9 | 3.1 ± 6.2 | 3.8 ± 8.7 | 4.9 ± 6.7 |
Number of thromboembolic events is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
| Events | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|---|
| Number of Thromboembolic Events | 0 | 0 | 1 | 0 | 0 |
Number of thromboembolic events is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Results for this outcome have not been posted.
Number of hypersensitivity type reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
| Reactions | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|---|
| Number of Hypersensitivity Type Reactions | 0 | 0 | 1 | 0 | 1 |
Number of hypersensitivity type reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Results for this outcome have not been posted.
Number of injection site reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
| Reactions | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|---|
| Number of Injection Site Reactions | 0 | 1 | 11 | 5 | 43 |
Number of injection site reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Results for this outcome have not been posted.
Number of participants with antibodies to concizumab is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
| Participants | Concizumab PPX |
|---|---|
| Number of Participants With Antibodies to Concizumab | 35 |
Number of participants with antibodies to concizumab is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.
Results for this outcome have not been posted.
Pre-dose (trough) concizumab plasma concentration is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
| nanograms per milliliter (ng/mL) | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Pre-dose (Trough) Concizumab Plasma Concentration (Ctrough) | 808.7 ± 263.4 | 570.9 ± 225.7 | 590.6 ± 600.9 | 717.3 ± 328.5 |
Pre-dose thrombin peak for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
| nanomoles per liter (nmol/L) | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Pre-dose Thrombin Peak | 104.2 ± 39.0 | 67.3 ± 88.7 | 76.2 ± 78.6 | 75.3 ± 43.1 |
Pre-dose free TFPI concentration for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
| ng/mL | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|
| Pre-dose Free Tissue Factor Pathway Inhibitor (TFPI) Concentration | 13.2 ± 106.4 | 15.2 ± 108.7 | 12.1 ± 123.0 | 11.0 ± 95.6 |
Maximum concizumab plasma concentration is presented. The observation period used for reporting the endpoint is on OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
| ng/mL | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|
| Maximum Concizumab Plasma Concentration (Cmax) | 992.2 ± 1.0 | 1514.1 ± 1.7 | 1153.0 ± 1.3 |
Area under the concizumab plasma concentration-time curve is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.
| nanogram*hour per milliliter (ng*hr/mL) | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|
| Area Under the Concizumab Plasma Concentration-time Curve (AUC) | 25991.5 ± 17069.7 | 47149.3 ± 38192.8 | 32903.5 ± 32741.2 |
Collected over Up to week 56 cut-off. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Previous on Demand: No Prophylaxis | 1/19 (5.3%) | 3/19 (15.8%) | 8/19 (42.1%) |
| Extension Arm 1: Previous on Demand: No Prophylaxis | 0/13 (0%) | 2/13 (15.4%) | 8/13 (61.5%) |
| Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | 4/33 (12.1%) | 9/33 (27.3%) | 15/33 (45.5%) |
| Arm 3: Concizumab Non-naive: Concizumab PPX | 1/21 (4.8%) | 2/21 (9.5%) | 13/21 (61.9%) |
| Arm 4: Concizumab Naive: Concizumab PPX | 1/60 (1.7%) | 9/60 (15%) | 35/60 (58.3%) |
| Event | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|---|
| Functional gastrointestinal disorderGastrointestinal disorders | 0/19 | 1/13 | 0/33 | 0/21 | 0/60 |
| Retroperitoneal haematomaGastrointestinal disorders | 0/19 | 1/13 | 0/33 | 0/21 | 0/60 |
| COVID-19Infections and infestations | 1/19 | 0/13 | 1/33 | 0/21 | 1/60 |
| HaematomaVascular disorders | 1/19 | 0/13 | 0/33 | 0/21 | 0/60 |
| Lower limb fractureInjury, poisoning and procedural complications | 1/19 | 0/13 | 0/33 | 0/21 | 0/60 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/19 | 0/13 | 0/33 | 0/21 | 0/60 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/19 | 0/13 | 1/33 | 0/21 | 0/60 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/19 | 0/13 | 0/33 | 1/21 | 0/60 |
| Haemoglobin decreasedInvestigations | 0/19 | 0/13 | 0/33 | 1/21 | 0/60 |
| EncephalitisInfections and infestations | 0/19 | 0/13 | 1/33 | 0/21 | 0/60 |
| Event | Arm 1: Previous on Demand: No Prophylaxis | Extension Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX |
|---|---|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/19 | 0/13 | 2/33 | 5/21 | 10/60 |
| COVID-19Infections and infestations | 0/19 | 1/13 | 2/33 | 5/21 | 5/60 |
| Upper respiratory tract infectionInfections and infestations | 1/19 | 1/13 | 2/33 | 4/21 | 3/60 |
| Viral upper respiratory tract infectionInfections and infestations | 0/19 | 2/13 | 0/33 | 0/21 | 1/60 |
| NasopharyngitisInfections and infestations | 1/19 | 0/13 | 2/33 | 3/21 | 4/60 |
| PyrexiaGeneral disorders | 1/19 | 0/13 | 3/33 | 3/21 | 4/60 |
| Injection site erythemaGeneral disorders | 0/19 | 0/13 | 1/33 | 1/21 | 7/60 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/19 | 0/13 | 0/33 | 2/21 | 0/60 |
| ConstipationGastrointestinal disorders | 1/19 | 0/13 | 0/33 | 2/21 | 2/60 |
| DiarrhoeaGastrointestinal disorders | 0/19 | 0/13 | 3/33 | 2/21 | 1/60 |
Baseline characteristic data is reported for on-treatment without data on initial regimen (OTexIR) analysis set which included the time period where participants were considered to be affected by on-demand treatment or treatment with the new concizumab dosing regimen excluding observation time during the initial concizumab PPX regimen.
| Age, Continuous(Years) | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX | Total |
|---|---|---|---|---|---|
| Mean | 32.3 ± 17.6 | 24.8 ± 14.4 | 35.1 ± 10.0 | 26.4 ± 11.5 | 28.1 ± 13.5 |
| Sex: Female, Male(Participants) | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 19 | 29 | 15 | 55 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 0 | 2 | 6 |
| Not Hispanic or Latino | 16 | 25 | 15 | 52 | 108 |
| Unknown or Not Reported | 2 | 1 | 0 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Arm 1: Previous on Demand: No Prophylaxis | Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) | Arm 3: Concizumab Non-naive: Concizumab PPX | Arm 4: Concizumab Naive: Concizumab PPX | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 1 | 3 |
| Asian | 6 | 13 | 4 | 12 | 35 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 0 | 3 | 8 |
| White | 9 | 9 | 11 | 38 | 67 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 0 | 1 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
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Studies of the drug tested here: Concizumab