Condition or disease | Intervention/treatment | Phase |
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Atopic Dermatitis | Drug: Tezepelumab Other: Placebo | Phase 2 |
All subjects will receive a SC dose of either investigational product or placebo as the first dose on day 1.
Subjects who are determined to be non-responders in Part A will receive tezepelumab SC Q2W following completion of all week 16 study activities. Nonresponders are defined as those subjects who have not achieved at least a 50% improvement in EASI at week 16 compared to baseline (day 1).
Safety follow-up is 18 weeks after the EOT visit (20 weeks after the final dose of investigational product).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 251 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. This study consists of Part A (the main study evaluating tezepelumab as a monotherapy) and Part B (a study evaluating tezepelumab as adjunctive therapy when combined with a topical corticosteroid regimen |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis |
Actual Study Start Date : | March 15, 2019 |
Actual Primary Completion Date : | May 12, 2020 |
Actual Study Completion Date : | December 22, 2020 |
Arm | Intervention/treatment |
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Experimental: Tezepelumab high dose
subcutaneous injection every 2 weeks
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Drug: Tezepelumab
Solution for injection
Other Name: AMG157
Other: Placebo Placebo solution for injection
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Experimental: Tezepelumab low dose
subcutaneous injection every 4 weeks
|
Drug: Tezepelumab
Solution for injection
Other Name: AMG157
Other: Placebo Placebo solution for injection
|
Experimental: Tezepelumab medium dose
subcutaneous injection every 2 weeks
|
Drug: Tezepelumab
Solution for injection
Other Name: AMG157
Other: Placebo Placebo solution for injection
|
Placebo Comparator: Placebo
subcutaneous injection every 2 weeks or every 4 weeks
|
Drug: Tezepelumab
Solution for injection
Other Name: AMG157
Other: Placebo Placebo solution for injection
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
Prior/Concomitant Therapy:
Other Exclusions:
Study Director: | MD | Amgen |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | January 10, 2019 | ||||||||||||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||||||||||||
Last Update Posted Date | February 21, 2021 | ||||||||||||||||||
Actual Study Start Date ICMJE | March 15, 2019 | ||||||||||||||||||
Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0/1) and 75% reduction of EASI at Week 16 [ Time Frame: Week 16 ] Evaluate the effect of tezepelumab compared with placebo, assessed using the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures |
Subject incidence of adverse events [ Time Frame: Day 1 ] Establish the safety and tolerability of tezepelumab compared with placebo
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Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis | ||||||||||||||||||
Official Title ICMJE | A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis | ||||||||||||||||||
Brief Summary | This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. | ||||||||||||||||||
Detailed Description |
All subjects will receive a SC dose of either investigational product or placebo as the first dose on day 1. Subjects who are determined to be non-responders in Part A will receive tezepelumab SC Q2W following completion of all week 16 study activities. Nonresponders are defined as those subjects who have not achieved at least a 50% improvement in EASI at week 16 compared to baseline (day 1). Safety follow-up is 18 weeks after the EOT visit (20 weeks after the final dose of investigational product). |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This phase 2b study is designed to evaluate the safety and efficacy of tezepelumab as a monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe AD. This study consists of Part A (the main study evaluating tezepelumab as a monotherapy) and Part B (a study evaluating tezepelumab as adjunctive therapy when combined with a topical corticosteroid regimen Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE | Atopic Dermatitis | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||||
Actual Enrollment ICMJE |
251 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
300 | ||||||||||||||||||
Actual Study Completion Date ICMJE | December 22, 2020 | ||||||||||||||||||
Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy:
Other Exclusions:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Australia, Canada, Czechia, Estonia, Germany, Hungary, Japan, Korea, Republic of, Latvia, Poland, Spain, Switzerland, Ukraine, United Kingdom, United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03809663 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 20170755 2018-001997-52 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Amgen | ||||||||||||||||||
Study Sponsor ICMJE | Amgen | ||||||||||||||||||
Collaborators ICMJE | AstraZeneca | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | Amgen | ||||||||||||||||||
Verification Date | January 2021 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |