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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.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: etokimab (ANB020) Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Solution
Experimental: Group 1
etokimab (ANB020)
 Biological: etokimab (ANB020)
Humanized Monoclonal Antibody
Experimental: Group 2
etokimab (ANB020)
 Biological: etokimab (ANB020)
Humanized Monoclonal Antibody
Experimental: Group 3
etokimab (ANB020)
 Biological: etokimab (ANB020)
Humanized Monoclonal Antibody
Experimental: Group 4
etokimab (ANB020)
 Biological: etokimab (ANB020)
Humanized Monoclonal Antibody


Outcome Measures
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Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Safety of ANB020 in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Week 16 ]
    Number of participants with treatment-related adverse events.

  2. Proportion of subjects who achieve Investigator's Global Assessment (IGA) response of 0 (clear) or 1 (almost clear) [ Time Frame: Week 16 ]
  3. Proportion of subjects who achieve IGA Score reduction of ≥2 [ Time Frame: Week 16 ]
  4. Percent change in peak weekly averaged numerical rating scale (NRS) for pruritus score from baseline [ Time Frame: Week 16 ]
  5. Proportion of subjects who achieve weekly averaged NRS score reduction from baseline of ≥3 [ Time Frame: Week 16 ]
  6. Proportion of subjects with EASI 50 (≥50% improvement from baseline). [ Time Frame: Week 16 ]
  7. Proportion of subjects with EASI 75 (≥75% improvement from baseline). [ Time Frame: Week 16 ]
  8. Percent change in EASI score from baseline to clinical assessment time points prior to Week 16 [ Time Frame: Through Week 16 ]
  9. Absolute change in EASI score from baseline. [ Time Frame: Week 16 ]
  10. Percent change in percent Body Surface Area (BSA) from baseline [ Time Frame: Week 16 ]
  11. Absolute change in percent BSA from baseline [ Time Frame: Week 16 ]
  12. Percent change in Scoring Atopic Dermatitis (SCORAD) score from baseline. [ Time Frame: Week 16 ]
  13. Absolute change in SCORAD scores from baseline. [ Time Frame: Week 16 ]

Other Outcome Measures:
  1. Cmax - peak ANB020 concentration in serum following multiple dose administration [ Time Frame: Through study completion, Week 24 ]
  2. Ctrough - trough ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]
  3. Clast - last positive (quantifiable) ANB020 concentration in serum [ Time Frame: Through study completion, Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533751


Contacts
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Contact: AnaptysBio, Inc 858-362-6295 ANB020-005@anaptysbio.com

Locations
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Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Marco Londei, M.D. AnaptysBio, Inc.
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT03533751    
Other Study ID Numbers: ANB020-005
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnaptysBio, Inc.:
ANB020
etokimab
eczema
moderate to severe
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases