Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ATLAS  

Official title:

A 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533751
• Other study ID #: ANB020-005
• Secondary ID: 2018-000331-27
• Status: Completed
• Phase: Phase 2
• Start date: June 19, 2018
• Est. completion date: December 3, 2019

Study information

• Verified date: April 2023
• Source: AnaptysBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female participants 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 kilogram per square meter (kg/m^2) at screening.

3. Clinically confirmed diagnosis of 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. Participants 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-interleukin (IL)-33 antibody.

3. Exposure to an investigational or licensed or other anti T-helper 2 (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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• Etokimab
Humanized monoclonal antibody, administered by subcutaneous injection

Drug:
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
Canada	Le centre de Recherche en Dermatologie du Drummondville	Drummondville	Quebec
Canada	Alberta DermaSurgery Centre	Edmonton	Alberta
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	ICLS Dermatology and Plastic Surgery	Oakville	Ontario
Canada	Ottawa Allergy Research Corporation	Ottawa	Ontario
Canada	Centre de Recherche Dermatologique du Quebec Metropolitain	Québec	Quebec
Canada	Windsor Clinical Research Inc.	Windsor	Ontario
Czechia	CCR Brno, s.r.o.	Brno
Czechia	CCR Czech, a.s.	Pardubice
Czechia	Fakultni nemocnice v Motole	Prague
Czechia	Dermatovenereology	Praha
Czechia	CLINTRIAL s.r.o.	Praha 10
Czechia	Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.	Ústí Nad Labem
Germany	Fachklinik Bad Bentheim Dermatologie	Bad Bentheim	Niedersachsen
Germany	Charite Universitaetsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	Praxis fuer Haut- und Geschlechtskrankheiten	Berlin
Germany	Universitaetsklinikum Bonn AoeR	Bonn	Nordrhein Westfalen
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden	Niedersachsen
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Hessen
Germany	SRH Wald-Klinikum Gera gGmbH	Gera	Thueringen
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig Holstein
Germany	Universitaetsklinikum Leipzig AoeR	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig Holstein - Campus Luebeck	Luebeck	Schleswig Holstein
Germany	Klinikum der Ludwigs-Maximilians-Universitaet Muenchen	Muenchen	Bayern
Germany	Universitaetsklinikum Tuebingen	Tuebingen	Baden Wuerttemberg
Poland	ClinicMed Daniluk, Nowak Spólka Jawna	Bialystok
Poland	Centrum Badan Klinicznych P.I. House Sp. z o.o.	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Centrum Medyczne All-Med	Kraków
Poland	Dermoklinika	Lódz
Poland	NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie	Lódz
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"	Lublin
Poland	Centrum Medyczne Medyk	Rzeszów
Poland	Laser Clinic S.C.	Szczecin
Poland	Nasz Lekarz Przychodnie Medyczne	Torun
Poland	Clinical Research Group Sp. z o.o.	Warszawa
Poland	Wojewodzki Szpital Specjalistyczny we Wroclawiu	Wroclaw
United Kingdom	MAC UK Neuroscience Ltd / MAC Clinical Research Ltd	Cannock	Staffordshire
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	MAC UK Neurosciences Ltd / MAC Clinical Research	Manchester	Greater Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Churchill Hospital	Oxford
United States	Georgia Pollens Clinical Research Centers, Inc.	Albany	Georgia
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Ohio State University Clinical Trials Management Office	Columbus	Ohio
United States	Coppell Allergy and Asthma PA	Coppell	Texas
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Encino Research Group	Encino	California
United States	Forest Hills Dermatology Group	Forest Hills	New York
United States	Center for Medical Research	Houston	Texas
United States	Irvine Center for Clinical Research, Inc.	Irvine	California
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	JDR Dermatology Research	Las Vegas	Nevada
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	DermResearch, PLLC	Louisville	Kentucky
United States	Dermatologic Surgery Specialists	Macon	Georgia
United States	Marietta Dermatology & The Skin Cancer Center - Marietta	Marietta	Georgia
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Medical Research Center of Miami	Miami	Florida
United States	SRG	New York	New York
United States	Midwest Allergy, Sinus and Asthma, SC	Normal	Illinois
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Compass Research Main	Orlando	Florida
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Advanced Medical Research, PC	Sandy Springs	Georgia
United States	Clinical Science Institute	Santa Monica	California
United States	DermResearch Center of New York	Stony Brook	New York
United States	Moore Clinical Research Inc. - Brandon	Tampa	Florida
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	The Dermatology Group	Verona	New Jersey
United States	Grekin Skin Institute - Warren	Warren	Michigan
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AnaptysBio, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score	EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).	Baseline and Week 16
Secondary	Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16	EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).	Baseline and Week 16
Secondary	Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16	EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).	Baseline and Week 16
Secondary	Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16	EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none [0], mild [1], moderate [2], or severe [3]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).	Baseline and Week 16
Secondary	Number of Participants Who Achieved a Reduction of = 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16	The vIGA-AD is a static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present; Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting; Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting; Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present; Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread in extent. Oozing or crusting may be present.; Number of participants with =2 points reduction in vIGA-AD is presented.	Baseline and Week 16
Secondary	Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16	vIGA-AD is static 5-point scale to evaluate AD severity globally: 0: Clear - No inflammatory signs of AD (no erythema, no induration/papulation, no lichenification, no oozing/crusting). Postinflammatory hyperpigmentation and/or hypopigmentation may be present; Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting; Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting; Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present; Severe - Marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification. Disease is widespread. Oozing or crusting may be present Participants who achieved vIGA-AD response of 0 (clear) or 1 (almost clear) are reported.	Week 16
Secondary	Number of Participants Who Achieved a Reduction of = 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16	Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.	Baseline and Week 16
Secondary	Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16	Participants were asked to rate itch (pruritis) intensity at its worst (peak) during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch) in a daily electronic diary. Weekly average was calculated as the average of the 7 days before each visit.	Baseline and Week 16
Secondary	Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16	SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). The extent is assessed using the rule of 9 to calculate the affected area (A) as extent of disease (0 [no disease]-102 [worst disease]). The intensity part of the SCORAD (B) consists of 6 items: erythema, oedema/papulation, excoriations, lichenification, oozing/crusts and dryness, each graded on a scale from 0 (none) to 3 (severe), for a total score of 0 (none) to 18 (severe intensity). Subjective items (C) include daily pruritus and sleeplessness, each scored on a visual analogue scale (VAS) from 0 to 10 (itch: 0 [no itch] to 10 [worst imaginable itch] and sleeplessness: 0 [no sleeplessness] to 10 [worst imaginable sleeplessness]) (total score 0-20). SCORAD is calculated as A/5 + 7B/2 + C, and ranges from 0 (no AD present) to 103.4 (worst).	Baseline and Week 16
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16	The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. A negative change from Baseline indicates improvement.	Baseline and Week 16
Secondary	Number of Participants Who Experienced an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent adverse event (TEAE) is any AE that started or worsened in severity on or after the date and time of the study drug administration. A serious adverse event (SAE) is as any untoward medical occurrence that, at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent disability/incapacity; Was a congenital anomaly/birth defect.	From first dose to Week 24

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