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

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 |
- Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]
- 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 ]
- 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 ]

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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 |
Inclusion Criteria:
- Male or female subjects must be 18 to 75 years of age, at the time of signing the informed consent.
- Body mass index (BMI) of 18 to ≤35 kg/m2 at screening.
- Clinically confirmed diagnosis AD.
- 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.
- 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.
- Daily use of non-medicated emollient for at least 7 days prior to baseline.
Exclusion Criteria:
- Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
- Prior exposure to an anti-IL-33 antibody.
- 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.
- 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.
- 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.
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Director: | Marco Londei, M.D. | AnaptysBio, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ANB020 etokimab eczema moderate to severe |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |