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This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).

Primary Purpose

Atopic Dermatitis Eczema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ANB032
Placebo
Sponsored by
AnaptysBio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis Eczema focused on measuring ANB032, B and T lymphocyte attenuator BTLA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Male or female aged 18 to 65 years and in good general health Moderate to severe AD for at least 6 months prior to Randomization History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable EASI score ≥ 16 at Screening and at Randomization vIGA AD score ≥ 3 at Screening and at Randomization AD involved BSA ≥ 10% at Screening and at Randomization Key Exclusion Criteria: Any factors that in the Investigator's opinion would predispose the subject to develop an infection Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status Not able to tolerate SC drug administration Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization

Sites / Locations

  • First Oc DermatologyRecruiting
  • Center For Dermatology Clinical Research Inc.Recruiting
  • Antelope Valley Clinical TrialsRecruiting
  • Torrance Clinical Research Institute Inc.Recruiting
  • Clinical Science InstituteRecruiting
  • Lcc Medical Research Institute, LlcRecruiting
  • Floridian Research Institute LlcRecruiting
  • Advanced Medical ResearchRecruiting
  • Ds Research IndianaRecruiting
  • Southern Indiana Clinical TrialsRecruiting
  • Ds Research - KentuckyRecruiting
  • University of Michigan - Dept. of DermatologyRecruiting
  • Henry Ford Medical Center - New Center OneRecruiting
  • Medisearch Clinical TrialsRecruiting
  • Fife Dermatology PcRecruiting
  • Juva Skin & Laser CenterRecruiting
  • Darst DermatologyRecruiting
  • Wilmington Dermatology CenterRecruiting
  • Dermatologists of Southwest OhioRecruiting
  • Oregon Medical Research CenterRecruiting
  • Tennessee Clinical Research CenterRecruiting
  • Reveal Research InstituteRecruiting
  • North Texas Center For Clinical ResearchRecruiting
  • Progressive Clinical ResearchRecruiting
  • Dermatology Clinical Research Center of San AntonioRecruiting
  • Enverus Medical ResearchRecruiting
  • Simcoderm Medical and Surgical Dermatology CenterRecruiting
  • Kingsway Clinical ResearchRecruiting
  • DermeffectsRecruiting
  • Nectar Research Group, Inc.Recruiting
  • North Bay Dermatology CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ANB032 SC Dose 1

ANB032 SC Dose 2

ANB032 SC Dose 3

Placebo

Arm Description

This arm will receive treatment SC

This arm will receive treatment SC

This arm will receive treatment SC

This arm will receive Placebo SC

Outcomes

Primary Outcome Measures

Mean change from Baseline in EASI at Week 14
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.

Secondary Outcome Measures

Mean percent change from Baseline in EASI at Week 14
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Proportion of subjects who achieve ≥ 75% reduction (improvement) from Baseline in EASI-75 at Week 14
Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14

Full Information

First Posted
June 6, 2023
Last Updated
October 16, 2023
Sponsor
AnaptysBio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05935085
Brief Title
This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).
Official Title
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnaptysBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate to severe atopic dermatitis (AD).
Detailed Description
This is a Phase 2, randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of ANB032 in subjects with moderate to severe atopic dermatitis (AD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
Keywords
ANB032, B and T lymphocyte attenuator BTLA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ANB032 SC Dose 1
Arm Type
Experimental
Arm Description
This arm will receive treatment SC
Arm Title
ANB032 SC Dose 2
Arm Type
Experimental
Arm Description
This arm will receive treatment SC
Arm Title
ANB032 SC Dose 3
Arm Type
Experimental
Arm Description
This arm will receive treatment SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This arm will receive Placebo SC
Intervention Type
Drug
Intervention Name(s)
ANB032
Intervention Description
BTLA agonist antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mean change from Baseline in EASI at Week 14
Description
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
Mean percent change from Baseline in EASI at Week 14
Description
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.
Time Frame
Baseline to Week 14
Title
Proportion of subjects who achieve ≥ 75% reduction (improvement) from Baseline in EASI-75 at Week 14
Time Frame
Baseline to Week 14
Title
Proportion of subjects who achieve a vIGA-AD score of 0 or 1 and ≥ 2-point reduction (improvement) from Baseline in vIGA-AD score at Week 14
Time Frame
Baseline to Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female aged 18 to 65 years and in good general health Moderate to severe AD for at least 6 months prior to Randomization History of inadequate response to treatment for AD with topical medications or for whom topical treatments are otherwise medically inadvisable EASI score ≥ 16 at Screening and at Randomization vIGA AD score ≥ 3 at Screening and at Randomization AD involved BSA ≥ 10% at Screening and at Randomization Key Exclusion Criteria: Any factors that in the Investigator's opinion would predispose the subject to develop an infection Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status Not able to tolerate SC drug administration Tanning booth use or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks before Randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Ilan
Phone
858-732-0100
Email
Clinicaltrialinfo@anaptysbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyne Papacharalambous, MD
Organizational Affiliation
AnaptysBio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Name
Center For Dermatology Clinical Research Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Lcc Medical Research Institute, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Floridian Research Institute Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Medical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Ds Research Indiana
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Indiana Clinical Trials
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Recruiting
Facility Name
Ds Research - Kentucky
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan - Dept. of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Medisearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Name
Fife Dermatology Pc
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Juva Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
11421
Country
United States
Individual Site Status
Recruiting
Facility Name
Darst Dermatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmington Dermatology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28205
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatologists of Southwest Ohio
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Medical Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Name
Reveal Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Center For Clinical Research
City
Frisco
State/Province
Texas
ZIP/Postal Code
75304
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Colombia
ZIP/Postal Code
V3V 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Simcoderm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kingsway Clinical Research
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M8X 1Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dermeffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Nectar Research Group, Inc.
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
North Bay Dermatology Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
P1B327
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD).

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