Tralokinumab in Combination With Topical Corticosteroids... | NCT03761537

Label	Type	Description	Intervention Names
Tralokinumab + TCS	Experimental	4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.	Drug: Tralokinumab
Placebo + TCS	Placebo Comparator	4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tralokinumab	Drug	Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.

Measure	Description	Time Frame
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16	EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.	Week 0 to Week 16

Measure	Description	Time Frame
Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16	Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.	Week 0 to Week 16

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Age 18 and above
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
History of AD for 1 year or more
Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Key Exclusion Criteria:

Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
History of any active skin infection within 1 week prior to randomisation
History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Name	Affiliation	Role
Medical Expert	LEO Pharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Leo Pharma Investigationel Site		Brussels		1090	Belgium
Leo Pharma Investigationel Site

ID	Title	Description
FG000	Tralokinumab + TCS	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 15, 2020	Sep 21, 2021

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

Years

Title

Denominators

Categories

Title	Measurements
	OG00064.2 OG00150.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.	Mantel Haenszel	Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.	0.018	This endpoint was the first endpoint in the sequential testing hierarchy.	Risk Difference (RD)	14.1			2-Sided	95	2.5	25.7

Secondary

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16

Subjects will assess their worst itch severity over the past 24 hours using an 11-point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).

Posted

Number

Percentage of responders

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts

Secondary

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16

SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

Full analysis set (FAS).

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16

DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on different aspects of their health-related quality of life (HRQoL) over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = not at all ∕not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor HRQoL.

Full Set Analysis (FAS).

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0 to Week 16

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Secondary

Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16

IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Full analysis set (FAS).

Posted

Number

Percentage of responders

Week 16

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at Week 0 followed by a dose of 300 mg tralokinumab Q2W from Week 2 to Week 16.
OG001	Placebo+TCS	Participants in the initial treatment period (Week 0 to Week 16) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at Week 0 followed by administration of placebo every second week from Week 2 to Week 16.

Units	Counts
Participants

Secondary

At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26

Full analysis set (FAS).

Posted

Number

Percentage of responders

Week 0 to Week 26

ID	Title	Description
OG000	Tralokinumab	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
OG001	Placebo	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.

Units	Counts

Secondary

Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26

Subjects will assess their worst itch severity over the past 24 hours using an 11-point numeric rating scale ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Participants in the full analysis set with a Worst Daily Pruritus NRS (weekly average) of at least 4 at baseline (Week 0).

Posted

Number

Percentage of responders

Week 0 to Week 26

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
OG001	Placebo+TCS	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.

Secondary

Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26

SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.

Full analysis set (FAS).

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0 to Week 26

ID	Title	Description
OG000	Tralokinumab	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
OG001	Placebo	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.

Units	Counts
Participants

Secondary

Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26

Full Set Analysis (FAS).

Posted

Least Squares Mean

Standard Error

Units on a scale

Week 0 to Week 26

ID	Title	Description
OG000	Tralokinumab	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
OG001	Placebo	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.

Secondary

Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26

IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Full analysis set (FAS).

Posted

Number

Percentage of responders

Week 26

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
OG001	Placebo+TCS	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.

Units	Counts
Participants

Secondary

Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40

Presence of ADA from Week 0 to Week 40 was measured. Data were reported in the following categories: positive (presence of ADA at baseline and/or presence of ADA at at least 1 post-baseline assessment), perishing (presence of ADA at baseline and absence of ADA at all post-baseline assessments), negative (absence of ADA at all assessments), no post-baseline ADA assessment.

Posted

Count of Participants

Participants

Week 0 to Week 40

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).
OG001	Placebo+TCS	Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).

Units	Counts
Participants

Secondary

Number of Adverse Events From Week 0 to Week 40

All adverse events are presented below under Adverse Events

Posted

Number

number of adverse events

Week 0 to Week 40

ID	Title	Description
OG000	Tralokinumab+TCS	Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).
OG001	Placebo+TCS	Participants in the entire trial period, including the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed, and the safety follow-up period (up to Week 40).

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Period: Tralokinumab+TCS	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24. For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.	138	1	138	107	138
EG001	Treatment Period: Placebo+TCS	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24. For the treatment period, only AEs with a frequency above 2% will be reported. The exception is that AEs reported in the safety follow-up period will also be reported for the treatment period. The total AEs will represent all AEs reported in the treatment period.	137	5	137	108	137
EG002	Safety Follow-up Period: Tralokinumab+TCS	Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND). For the safety follow-up period, all AEs will be reported.	75	0	75	4	75
EG003	Safety Follow-up Period: Placebo+TCS	Participants who spent any amount of time in the safety follow-up period, independently of the treatment(s) received before. No treatment was administered to the participants during the safety follow-up period. Eligible participants were invited to enter a long-term extension trial conducted under a separate protocol (LP0162-1337, ECZTEND). For the safety follow-up period, all AEs will be reported.	83	1	83	6	83

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG0030 events0 affected83 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Peripheral nerve injury	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00053 events37 affected138 at risk EG00146 events35 affected137 at risk EG0022 events2 affected75 at risk EG0031 events1 affected83 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG00012 events10 affected138 at risk EG00111 events10 affected137 at risk EG0020 events0 affected75 at risk EG003
Folliculitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0006 events6 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0006 events6 affected138 at risk EG0013 events2 affected137 at risk EG0020 events0 affected75 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0008 events5 affected138 at risk EG0016 events6 affected137 at risk EG0020 events0 affected75 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0006 events5 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0004 events4 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0004 events4 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0004 events3 affected138 at risk EG0015 events5 affected137 at risk EG0020 events0 affected75 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0014 events4 affected137 at risk EG0020 events0 affected75 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0004 events3 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0002 events2 affected138 at risk EG00110 events5 affected137 at risk EG0020 events0 affected75 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0016 events6 affected137 at risk EG0020 events0 affected75 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0014 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG00011 events7 affected138 at risk EG00126 events16 affected137 at risk EG0020 events0 affected75 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG00012 events6 affected138 at risk EG0016 events5 affected137 at risk EG0020 events0 affected75 at risk EG003
Diffuse alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Non-systematic Assessment	EG00025 events21 affected138 at risk EG00118 events13 affected137 at risk EG0020 events0 affected75 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0006 events6 affected138 at risk EG0014 events4 affected137 at risk EG0020 events0 affected75 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0005 events4 affected138 at risk EG0012 events2 affected137 at risk EG0020 events0 affected75 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0002 events2 affected138 at risk EG0013 events3 affected137 at risk EG0021 events1 affected75 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Non-systematic Assessment	EG0000 events0 affected138 at risk EG0014 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0004 events4 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Injection site pain	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0005 events4 affected138 at risk EG0013 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Influenza like illness	General disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0005 events4 affected138 at risk EG0019 events8 affected137 at risk EG0020 events0 affected75 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0005 events4 affected138 at risk EG0017 events7 affected137 at risk EG0020 events0 affected75 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0018 events8 affected137 at risk EG0020 events0 affected75 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0018 events5 affected137 at risk EG0020 events0 affected75 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Non-systematic Assessment	EG0001 events1 affected138 at risk EG0013 events3 affected137 at risk EG0020 events0 affected75 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 20.0	Non-systematic Assessment	EG0008 events6 affected138 at risk EG0015 events5 affected137 at risk EG0020 events0 affected75 at risk EG003
Dry eye	Eye disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0011 events1 affected137 at risk EG0020 events0 affected75 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Non-systematic Assessment	EG0003 events3 affected138 at risk EG0017 events7 affected137 at risk EG0020 events0 affected75 at risk EG003
Urinary tract infection	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Lower respiratory tract infection	Infections and infestations		Non-systematic Assessment	EG0000 affected138 at risk EG0012 affected137 at risk EG0020 events0 affected75 at risk EG003
Pyelonephritis	Infections and infestations		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Renal cyst	Renal and urinary disorders		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0020 events0 affected75 at risk EG003
Cholelithiasis	Hepatobiliary disorders		Non-systematic Assessment	EG0000 events0 affected138 at risk EG0010 events0 affected137 at risk EG0021 events1 affected75 at risk EG003

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Tralokinumab + TCS	Participants in the treatment period (Week 0 to Week 26) treated with tralokinumab every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants received a loading dose of 600 mg tralokinumab at baseline followed by a dose of 300 mg tralokinumab Q2W from Week 2. The last dose of IMP was administered at Week 24.
BG001	Placebo + TCS	Participants in the treatment period (Week 0 to Week 26) treated with placebo every second week (Q2W) and topical corticosteroid (TCS) as needed. Participants were administered placebo at baseline followed by administration of placebo every second week from Week 2. The last dose of IMP was administered at Week 24.
BG002	Total	Total of all reporting groups