EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis

Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis

NCT ID

Therapeutic Area

Research Site

A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects with Moderate-to-Severe Atopic Dermatitis

EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.

The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment.

The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.

Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12

The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category "Number Analyzed" is number of participants analyzed for this outcome measure.

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12

TEAEs

TESAEs

An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.

As-treated population included all treated participants, grouped according to actual treatment received.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Blood pressure increased

Pyrexia

Acute coronary syndrome

Angina pectoris

Hypertension

Pallor

Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were  present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.

Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events

Anaemia

Lymphopenia

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Blood creatinine increased

Blood immunoglobulin E increased

Gamma-glutamyltransferase increased

Hepatic function abnormal

Hyperbilirubinaemia

Liver function test abnormal

Glycosuria

Leukocyturia

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.

Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events

AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.

Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events

EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.

Adjusted Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12

The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.

Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12

SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.

Adjusted Percentage of Participants Achieving 50 percent (%) Reduction From Baseline in SCORAD at Week 12

Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.

Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day mean score) at Week 12

Overall Study

95 participants were considered screen failures and 204 participants were randomized and treated in the study.

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.	Other: Placebo Subcutaneous injection with placebo
Experimental: Tralokinumab Dose 1 Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.	Biological/Vaccine: Tralokinumab Dose 1 Subcutaneous injection with tralokinumab
Experimental: Tralokinumab Dose 2 Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.	Biological/Vaccine: Tralokinumab Dose 2 Subcutaneous injection with tralokinumab
Experimental: Tralokinumab Dose 3 Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.	Biological/Vaccine: Tralokinumab Dose 3 Subcutaneous injection with tralokinumab

Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults with Atopic Dermatitis - D2213C00001

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

Study type

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Study design

Verification:

Sponsors

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Documents available

Trial Results Summaries

Contacts

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