Trial Outcomes & Findings for Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND (NCT NCT03587805)
NCT ID: NCT03587805
Last Updated: 2025-03-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1672 participants
Primary outcome timeframe
From Week 0 up to Week 268
Results posted on
2025-03-11
Participant Flow
This trial was conducted at 309 sites that screened subjects in 11 countries.
Participant milestones
| Measure |
Tralokinumab, All Subjects
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266\*: SC injection of tralokinumab maintenance dose.
\*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Overall Study
STARTED
|
1672
|
|
Overall Study
COMPLETED
|
1143
|
|
Overall Study
NOT COMPLETED
|
529
|
Reasons for withdrawal
| Measure |
Tralokinumab, All Subjects
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266\*: SC injection of tralokinumab maintenance dose.
\*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Overall Study
Adverse Event
|
72
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
78
|
|
Overall Study
Withdrawal by Subject
|
105
|
|
Overall Study
Lack of Efficacy
|
119
|
|
Overall Study
Reason unknown
|
26
|
|
Overall Study
COVID_19 pandemic
|
4
|
|
Overall Study
Various reasons
|
121
|
|
Overall Study
Withdrawal by parent/guardian
|
3
|
Baseline Characteristics
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND
Baseline characteristics by cohort
| Measure |
Tralokinumab, All Subjects
n=1672 Participants
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266\*: SC injection of tralokinumab maintenance dose.
\*The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Age, Categorical
<=18 years
|
103 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1498 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
71 Participants
n=5 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
709 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
963 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1558 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1194 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or african american
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
312 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American indian or alaska native
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific islander
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
237 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
69 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
384 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
181 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
228 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
70 participants
n=5 Participants
|
|
Region of Enrollment
France
|
73 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
268 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
127 participants
n=5 Participants
|
|
Weight (kg)
|
77.1 Kg
STANDARD_DEVIATION 19.1 • n=5 Participants
|
|
Height (cm)
|
170.3 cm
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
BMI (kg/m^2)
|
26.52 kg/m^2
STANDARD_DEVIATION 6.04 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Week 0 up to Week 268Outcome measures
| Measure |
Tralokinumab, All Subjects
n=1672 Participants
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose.The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Number of Adverse Events From Baseline Through the Last Treatment Visit (up to Week 268)
|
8119 events
|
SECONDARY outcome
Timeframe: From Week 16 up to Week 248Population: Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders.
The IGA is an instrument used in clinical trials to rate the severity of the subject's global atopic dermatitis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Tralokinumab, All Subjects
n=1647 Participants
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose.The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 16
|
47.3 percentage of responders
Interval 44.9 to 49.8
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 56
|
48.5 percentage of responders
Interval 45.9 to 51.1
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 88
|
48.6 percentage of responders
Interval 46.1 to 51.1
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 104
|
47.1 percentage of responders
Interval 44.6 to 49.6
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 136
|
48.7 percentage of responders
Interval 46.2 to 51.3
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 152
|
46.8 percentage of responders
Interval 44.1 to 49.4
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 184
|
46.7 percentage of responders
Interval 44.1 to 49.3
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 216
|
47.2 percentage of responders
Interval 44.4 to 50.0
|
|
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
IGA 0/1 at Week 248
|
46.9 percentage of responders
Interval 44.1 to 49.7
|
SECONDARY outcome
Timeframe: From Week 16 up to Week 248Population: Modified non-responder analysis with data multiply imputed using a hypothetical strategy. Response is based on observed and multiply imputed data. If a participant permanently discontinued IMP due to lack of efficacy or adverse event before the analyzed visit, they are considered non-responders.
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.
Outcome measures
| Measure |
Tralokinumab, All Subjects
n=1639 Participants
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose.The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 16
|
77.0 percentage of responders
Interval 74.9 to 79.0
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 56
|
75.2 percentage of responders
Interval 72.9 to 77.4
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 88
|
75.1 percentage of responders
Interval 72.9 to 77.3
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 104
|
74.6 percentage of responders
Interval 72.3 to 76.8
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 136
|
74.1 percentage of responders
Interval 71.7 to 76.3
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 152
|
73.0 percentage of responders
Interval 70.6 to 75.2
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 184
|
72.3 percentage of responders
Interval 69.7 to 74.6
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 216
|
72.1 percentage of responders
Interval 69.7 to 74.5
|
|
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) Relative to Baseline in Parent Trial, at Weeks 16, 56, 88, 104, 136, 152, 184, 216, and 248
EASI75 at Week 248
|
71.7 percentage of responders
Interval 69.2 to 74.1
|
Adverse Events
Tralokinumab, All Subjects
Serious events: 151 serious events
Other events: 924 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Tralokinumab, All Subjects
n=1672 participants at risk
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Cardiac disorders
Acute myocardial infarction
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Cardiac disorders
Atrial flutter
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Atrial tachycardia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Coronary artery disease
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Coronary artery occlusion
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Coronary artery stenosis
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Cardiac disorders
Myocardial infarction
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Cardiac disorders
Pericarditis
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Cardiac disorders
Tachycardia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Atopic cataract
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Cataract
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Eye disorders
Cataract nuclear
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Corneal disorder
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Glaucoma
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Retinal detachment
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Eye disorders
Ulcerative keratitis
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Eye disorders
Vitreous haemorrhage
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Eye disorders
Vogt-Koyanagi-Harada disease
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Crohn disease
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
General disorders
Adverse drug reaction
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
General disorders
Pyrexia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Hepatobiliary disorders
cholelithiasis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Immune system disorders
Anaphylactic reaction
|
0.24%
4/1672 • Number of events 4 • From baseline up to week 268
|
|
Immune system disorders
Corneal graft rejection
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Immune system disorders
Hypersensitivity
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Appendicitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Appendicitis perforated
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Arthritis infective
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Colonic abscess
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Covid-19
|
0.30%
5/1672 • Number of events 5 • From baseline up to week 268
|
|
Infections and infestations
Dermatitis infected
|
0.12%
2/1672 • Number of events 3 • From baseline up to week 268
|
|
Infections and infestations
Diverticulitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Eczema herpeticum
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Infections and infestations
Encephalitis herpes
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Endocarditis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Giardiasis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Herpes zoster pharyngitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Infectious mononucleosis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Infectious pleural effusion
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Intervertebral discitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Localised infection
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Medical device site joint infection
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Peritonsillar abscess
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Pneumonia
|
0.06%
1/1672 • Number of events 2 • From baseline up to week 268
|
|
Infections and infestations
Pneumonia aspiration
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Pneumonia bacterial
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Post procedural infection
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Infections and infestations
Tonsilitis
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Infections and infestations
Tooth abscess
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Fall
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Seroma
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Investigations
Blood creatinine increased
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Musculoskeletal and connective tissue disorders
Intervertebral protrusion
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoid cystic carcinoma
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Encephalopathy
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Hypoaesthesia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Ischaemic stroke
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Nervous system disorders
Migraine with aura
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Multiple sclerosis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Radiculopathy
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Nervous system disorders
Transient ischaemic attack
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Pregnancy, puerperium and perinatal conditions
ruptured ectopic pregnancy
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Product Issues
Device dislocation
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Acute psychosis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Bipolar disorder
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Depression
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Irritability
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Major depression
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Psychotic disorder
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Schizophrenia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Suicidal ideation
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Psychiatric disorders
Suicide attempt
|
0.12%
2/1672 • Number of events 3 • From baseline up to week 268
|
|
Renal and urinary disorders
Bladder metaplasia
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
2/1672 • Number of events 2 • From baseline up to week 268
|
|
Renal and urinary disorders
Proteinuria
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Reproductive system and breast disorders
Endometriosis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
3/1672 • Number of events 3 • From baseline up to week 268
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
0.72%
12/1672 • Number of events 12 • From baseline up to week 268
|
|
Skin and subcutaneous tissue disorders
dermatitis psoriasiform
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Surgical and medical procedures
Alcohol detoxication
|
0.06%
1/1672 • Number of events 2 • From baseline up to week 268
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Vascular disorders
Hypertension
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.06%
1/1672 • Number of events 1 • From baseline up to week 268
|
Other adverse events
| Measure |
Tralokinumab, All Subjects
n=1672 participants at risk
Week 0: subcutaneous (SC) injection of tralokinumab loading dose.
From Week 2 up to Week 266: SC injection of tralokinumab maintenance dose. The length of treatment for each subject will depend on when they enter the trial, and on which parent trial and country they come from.
Tralokinumab: Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
|
|---|---|
|
Infections and infestations
Conjuctivitis
|
6.2%
103/1672 • Number of events 131 • From baseline up to week 268
|
|
Infections and infestations
Covid-19
|
17.6%
295/1672 • Number of events 317 • From baseline up to week 268
|
|
Infections and infestations
Nasopharyngitis
|
22.2%
372/1672 • Number of events 599 • From baseline up to week 268
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
147/1672 • Number of events 233 • From baseline up to week 268
|
|
Nervous system disorders
Headache
|
6.8%
114/1672 • Number of events 143 • From baseline up to week 268
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
21.0%
351/1672 • Number of events 620 • From baseline up to week 268
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER