Atopic Dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : tezepelumab
INN of investigational material : tezepelumab
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investi
Sponsors
Amgen K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided informed consent prior to initiation of any study specific activities/procedures. 2. Age greater than or equal to 18 to less than or equal to 75 years at screening. 3. Clinical diagnosis of chronic AD (also known as atopic eczema) for at least 2 years prior to screening and has confirmed AD (Hanifin and Rajka criteria for AD (Hanifin and Rajka, 1980). 4. AD that affects greater than or equal to' 10% body surface area as assessed by EASI at screening and on day 1. 5. An IGA score of greater than or equal to 3 at screening and on day 1. 6. An EASI score of greater than or equal to 16 at screening and on day 1. 7. Subject discontinued treatment with TCS, topical calcineurin inhibitors (TCI), and prescription moisturizers containing TCS or topical calcineurin inhibitors (TCI) for at least the 7 days immediately prior to the first dose of investigational product. 8. Documented recent history (within 12 months before the screening visit) of inadequate response to treatment with topical TCS or subjects for whom topical treatments are otherwise medically inadvisable (ie, because of important side effects or safety risks). - Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to IGA 0 = clear to IGA 2 = mild) despite treatment with a daily regimen of TCS of medium or higher potency (with or without TCI as appropriate).
Exclusion criteria
Exclusion criteria: 1. Active dermatologic conditions, which might confound the diagnosis of AD or would interfere with the assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, allergic contact dermatitis, or irritant contact dermatitis. 2. History of a clinically significant infection within 28 days prior to day 1 that, in the opinion of the investigator or medical monitor, might compromise the safety of the subject in the study, interfere with evaluation of the investigational product, or reduce the subject's ability to participate in the study. Clinically significant infections are defined as either of the following: 1) a systemic infection; or 2) a serious skin infection requiring parenteral antibiotic, antiviral, or antifungal medication. 3. Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or had failed to respond to standard of care therapy. 4. Documented medical history of chronic alcohol or drug abuse within 12 months prior to screening. 5. History of anaphylaxis following any biologic therapy. 6. Evidence of active liver disease at screening, including jaundice or aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase greater than twice the upper limit of normal (ULN). 7. Subjects who, in the opinion of the investigator, have evidence of active tuberculosis (TB), either treated or untreated, or a positive QuantiFERON-tuberculosis Gold (QFT-G) test for TB during screening. Subjects with an indeterminate QFT-G may be enrolled if they have ALL of the following: - No symptoms of TB: productive, prolonged cough (> 3 weeks); coughing up blood; fever; night sweats; unexplained appetite loss; unintentional weight loss - No evidence of active TB on chest radiograph within 3 months prior to the first dose of investigational product. Note: Chest radiograph is not part of screening procedure and will be the responsibility 8. Positive hepatitis B surface antigen or hepatitis C antibody serology. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll in the study. 9. Positive human immunodeficiency virus (HIV) test at screening or the subject is taking antiretroviral medications, as determined by medical history, prior medications, and/or the subject's verbal report. 10. History of malignancy, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >= 12 months prior to screening or other malignancies treated with apparent success with curative therapy >= 5 years prior to screening. 11. History or evidence of severe depression, schizophrenia, previous suicide attempts, or suicidal ideation. 12. Subjects who are unwilling to abstain from the use of TCS, TCI, and prescription moisturizers (those that contain TCS and TCI) from screening through week 16 (applies only to Part A subjects) 13. Subjects who have had side effects of topical medications including intolerance to treatment, hypersensitivity reactions, significant skin atrophy, or systemic effects as assessed by the investigator or by the subject's treating physician (applies only to Part B subjects) 14. More than or equal to 30% of the total lesional surface is located on areas of thin skin that cannot be safely treated with medium or higher potency TCS (eg, face, neck, intertriginous a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 1. Number of Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) (IGA 0/1) at Week 16 [ Time Frame: Week 16 ] The IGA allows investigators to assess overall disease severity at 1 given time point and consists of a 6-point severity scale from clear to severe disease - 0 = clear - 1 = almost clear - 2 = mild disease - 3 = moderate disease - 4 = severe disease - 5 = very severe disease The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment (Breuer et al, 2004). Participants who took rescue medication between Day 29 to Week 16 were considered non-responders. 2. Number of Participants Who Experienced a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16 [ Time Frame: Baseline and Week 16 ] The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders. | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics efficacy 1. Number of Participants Who Experienced a 50% or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI 50/90) at Week 16 [ Time Frame: Baseline and Week 16 ] The EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on key acute and chronic signs of inflammation (ie, erythema, induration/papulation, excoriation, and lichenification). A reduction in the EASI score indicates an improvement in severity. Participants who took rescue medication between Day 29 to Week 16 were considered non-responders. 2. Time to Achievement of 50%, 75% or 90% Reduction From Day 1 in Eczema Area and Severity Index (EASI 50/75/90) [ Time Frame: Day 1 up to End of Study Visit (Week 70) ] 3. Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 16 [ Time Frame: Baseline and Week 16 ] The SCORAD is a clinical tool for assessing the severity (ie, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with subjective symptoms (Kunz et al, 1997). The total score ranges from 0 to 103, with higher values indicating more severe disease. A negative change from baseline indicates an improvement in severity of disease. 4. Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16 [ Time Frame: Baseline and Week 16 ] Pruritus was assessed using an NRS (0-10) with 0 = no itch and 10 = worst imaginable itch. A negative change from baseline indicates an improvement in symptoms. 5. Serum Trough Concentrations of Tezepelumab After Q2W or Q4W Administration [ Time Frame: Pre-dose on Day 1, Week 2, 4, 12, 16, 24, 32, 40, 48, 50, 52, 58 and 70 ] Switchers were included up to Week 16 and were then excluded from the analysis after switching. All Tezepelumab participants received 420 mg of Tezepelumab on Day 1. 6. Serum Trough Concentrations of Tezepelumab After Switching to 420 mg Q2W Administration After Week 16 [ Time Frame: P | — |
Countries
Australia, Canada, Czechia, Estonia, Germany, Hungary, Korea, Latvia, Poland, Spain, Switzerland, Ukraine, United Kingdom, United States
Contacts
Public ContactContact Local
Amgen K.K.
Outcome results
None listed