A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD (ATLAS)
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ClinicalTrials.gov Identifier: NCT03533751 |
Recruitment Status : Unknown
Verified May 2019 by AnaptysBio, Inc..
Recruitment status was: Recruiting
First Posted : May 23, 2018
Last Update Posted : May 20, 2019
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Sponsor:
AnaptysBio, Inc.
Information provided by (Responsible Party):
AnaptysBio, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | April 27, 2018 | ||||
First Posted Date ICMJE | May 23, 2018 | ||||
Last Update Posted Date | May 20, 2019 | ||||
Actual Study Start Date ICMJE | May 23, 2018 | ||||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ] | ||||
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 |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD | ||||
Official Title ICMJE | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe Atopic Dermatitis | ||||
Brief Summary | This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD). | ||||
Detailed Description | This is a multi-center, randomized, double blind, placebo controlled, parallel group, dose ranging study investigating the efficacy, safety, and pharmacokinetic profile of ANB020 administered to adult subjects with moderate-to-severe atopic dermatitis. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment 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 | Unknown status | ||||
Estimated Enrollment ICMJE |
300 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2019 | ||||
Estimated Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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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 | Canada, Czechia, Germany, Poland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03533751 | ||||
Other Study ID Numbers ICMJE | ANB020-005 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | AnaptysBio, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | AnaptysBio, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | AnaptysBio, Inc. | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |