Atopic Dermatitis
Conditions
Brief summary
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
Detailed description
This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe AD. At baseline, the subjects will receive an initial SC dose of 600 mg tralokinumab. For the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.
Interventions
DRUGTralokinumab
Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration
Sponsors
LEO Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 12 years and above. * Subject able and willing to self-administer tralokinumab with Device A. * Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. * History of AD for ≥1 year. * A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable. * AD involvement of ≥10% body surface area at screening and baseline. * An EASI score of ≥12 at screening and ≥16 at baseline. * An IGA score of ≥3 at screening and at baseline. * Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
Exclusion criteria
* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment. * Use of tanning beds or phototherapy within 4 weeks prior to baseline. * Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline. * Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline. * Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline. * Active skin infections within 1 week prior to baseline. * Clinically significant infection within 4 weeks prior to baseline. * A helminth parasitic infection within 6 months prior to the date informed consent is obtained. * Tuberculosis requiring treatment within 12 months prior to screening. * Known primary immunodeficiency disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | At Week 16 | IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) |
| At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | At Week 16 | Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16 | From Week 0 to Week 16 | An AE will be considered treatment emergent if it started after the first injection of trial drug |
| Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | From Week 0 to Week 16 | Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tralokinumab Subcutaneous Dosing by an Autoinjector An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
Tralokinumab: Tralokinumab is a human recombinant monoclonal antibody of immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin-13 (IL-13) and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration | 136 |
| Total | 136 |
Baseline characteristics
| Characteristic | Tralokinumab Subcutaneous Dosing by an Autoinjector |
|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 20.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment United States | 136 participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 131 |
| other Total, other adverse events | 24 / 136 | 0 / 131 |
| serious Total, serious adverse events | 0 / 136 | 0 / 131 |
Outcome results
Primary
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition
Time frame: At Week 16
Population: FAS, full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab Subcutaneous Dosing by an Autoinjector | At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16 | 43.4 percentage of subjects |
Primary
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 participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Time frame: At Week 16
Population: FAS, full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab Subcutaneous Dosing by an Autoinjector | Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16 | 28.7 percentage of subjects |
Secondary
Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16
An AE will be considered treatment emergent if it started after the first injection of trial drug
Time frame: From Week 0 to Week 16
Population: SAF, safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab Subcutaneous Dosing by an Autoinjector | Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16 | 86 events |
Secondary
Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16
Serum samples for determination of presence or absence of ADA will be analysed using a validated bioanalytical method
Time frame: From Week 0 to Week 16
Population: SAF, safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tralokinumab Subcutaneous Dosing by an Autoinjector | Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16 | 0 participants |