A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD (ATLAS)

• Sponsor: AnaptysBio, Inc.
• Information provided by (Responsible Party): AnaptysBio, Inc.

Tracking Information

• First Submitted Date: April 27, 2018
• First Posted Date: May 23, 2018
• Last Update Posted Date: May 20, 2019
• Actual Study Start Date: May 23, 2018
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 21, 2018): Percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Week 16 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03533751 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe AD
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Atopic Dermatitis

Intervention

• Biological: etokimab (ANB020)
  Humanized Monoclonal Antibody
• Drug: Placebo
  Solution

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 21, 2018): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2019
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Canada, Czechia, Germany, Poland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03533751
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: AnaptysBio, Inc.
• Study Sponsor: AnaptysBio, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Marco Londei, M.D.; AnaptysBio, Inc.

• PRS Account: AnaptysBio, Inc.
• Verification Date: May 2019