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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 : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Tracking Information
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
 (submitted: May 21, 2018)
Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03533751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Safety of ANB020 in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Week 16 ]
    Number of participants with treatment-related adverse events.
  • Proportion of subjects who achieve Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear) [ Time Frame: Week 16 ]
  • Proportion of subjects who achieve IGA Score reduction of ≥2 [ Time Frame: Week 16 ]
  • Percent change in peak weekly averaged numerical rating scale (NRS) for pruritus score from baseline [ Time Frame: Week 16 ]
  • Proportion of subjects who achieve weekly averaged NRS score reduction from baseline of ≥3 [ Time Frame: Week 16 ]
  • Proportion of subjects with EASI 50 (≥50% improvement from baseline). [ Time Frame: Week 16 ]
  • Proportion of subjects with EASI 75 (≥75% improvement from baseline). [ Time Frame: Week 16 ]
  • Percent change in EASI score from baseline to clinical assessment time points prior to Week 16 [ Time Frame: Through Week 16 ]
  • Absolute change in EASI score from baseline. [ Time Frame: Week 16 ]
  • Percent change in percent Body Surface Area (BSA) from baseline [ Time Frame: Week 16 ]
  • Absolute change in percent BSA from baseline [ Time Frame: Week 16 ]
  • Percent change in Scoring Atopic Dermatitis (SCORAD) score from baseline. [ Time Frame: Week 16 ]
  • Absolute change in SCORAD scores from baseline. [ Time Frame: Week 16 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2018)
  • Cmax - peak ANB020 concentration in serum following multiple dose administration [ Time Frame: Through study completion, Week 24 ]
  • Ctrough - trough ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]
  • Clast - last positive (quantifiable) ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]
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
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Biological: etokimab (ANB020)
    Humanized Monoclonal Antibody
  • Drug: Placebo
    Solution
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Group 1
    etokimab (ANB020)
    Intervention: Biological: etokimab (ANB020)
  • Experimental: Group 2
    etokimab (ANB020)
    Intervention: Biological: etokimab (ANB020)
  • Experimental: Group 3
    etokimab (ANB020)
    Intervention: Biological: etokimab (ANB020)
  • Experimental: Group 4
    etokimab (ANB020)
    Intervention: Biological: etokimab (ANB020)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2018)
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:

  1. Male or female subjects must be 18 to 75 years of age, at the time of signing the informed consent.
  2. Body mass index (BMI) of 18 to ≤35 kg/m2 at screening.
  3. Clinically confirmed diagnosis AD.
  4. Eczema Area and Severity Index (EASI) score ≥16, body surface area (BSA) involvement ≥10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥3 at baseline.
  5. Subjects with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.
  6. Daily use of non-medicated emollient for at least 7 days prior to baseline.

Exclusion Criteria:

  1. Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
  2. Prior exposure to an anti-IL-33 antibody.
  3. Exposure to an investigational or licensed or other anti Th2 type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
  4. History of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study.
  5. Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
  6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AnaptysBio, Inc 858-362-6295 ANB020-005@anaptysbio.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AnaptysBio, Inc.
Study Sponsor  ICMJE AnaptysBio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marco Londei, M.D. AnaptysBio, Inc.
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