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Atopic DermatitisPhase 2ATLASNCT03533751

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

A Phase 2 study testing Etokimab in people with Atopic Dermatitis, run by AnaptysBio, Inc. at 81 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Etokimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
81 sitesin 6 countries
Study dates
19 Jun 2018to 3 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
  • Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m^2) at screening.
  • Clinically confirmed diagnosis of 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.
  • 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.
  • Daily use of non-medicated emollient for at least 7 days prior to baseline.

Who cannot join

  • Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
  • Prior exposure to an anti-interleukin (IL)-33 antibody.
  • 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.
  • 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.

Trial locations and contacts

81 sites in 6 countries.

81 sites in 6 countries

United States37 sites

  • Georgia Pollens Clinical Research Centers, Inc.

    Albany, Georgia, 31707

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400

  • Ohio State University Clinical Trials Management Office

    Columbus, Ohio, 43210

  • Coppell Allergy and Asthma PA

    Coppell, Texas, 75019

  • Dermatology Treatment and Research Center

    Dallas, Texas, 75230

  • Encino Research Group

    Encino, California, 91436

  • Forest Hills Dermatology Group

    Forest Hills, New York, 11375

  • Center for Medical Research

    Houston, Texas, 77056

  • Irvine Center for Clinical Research, Inc.

    Irvine, California, 92614

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • JDR Dermatology Research

    Las Vegas, Nevada, 89148

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • DermResearch, PLLC

    Louisville, Kentucky, 40217

  • Dermatologic Surgery Specialists

    Macon, Georgia, 31217

  • Marietta Dermatology & The Skin Cancer Center - Marietta

    Marietta, Georgia, 30060-1047

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Medical Research Center of Miami

    Miami, Florida, 33134

  • SRG

    New York, New York, 10021

  • Midwest Allergy, Sinus and Asthma, SC

    Normal, Illinois, 61761

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Skin Specialists, PC

    Omaha, Nebraska, 68144

  • Compass Research Main

    Orlando, Florida, 32806

  • Kansas City Dermatology, PA

    Overland Park, Kansas, 66215-2314

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220

  • Progressive Clinical Research, PA

    San Antonio, Texas, 78213

  • Advanced Medical Research, PC

    Sandy Springs, Georgia, 30328

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Washington University School of Medicine

    St Louis, Missouri, 63141

  • DermResearch Center of New York

    Stony Brook, New York, 11790

  • Moore Clinical Research Inc. - Brandon

    Tampa, Florida, 33609

  • Vital Prospects Clinical Research Institute, P.C.

    Tulsa, Oklahoma, 74136

  • The Dermatology Group

    Verona, New Jersey, 07044-2946

  • Grekin Skin Institute - Warren

    Warren, Michigan, 48088

  • Wilmington Dermatology Center

    Wilmington, North Carolina, 28403

Other trials in United States

Germany13 sites

  • Fachklinik Bad Bentheim Dermatologie

    Bad Bentheim, Lower Saxony, 48455

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Praxis fuer Haut- und Geschlechtskrankheiten

    Berlin, 13055

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53105

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Lower Saxony, 1307

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt am Main, Hesse, 60590

  • SRH Wald-Klinikum Gera gGmbH

    Gera, Thuringia, 7548

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, Saxony, 4103

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

    Munich, Bavaria, 80337

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Poland13 sites

  • ClinicMed Daniluk, Nowak Spółka Jawna

    Bialystok

  • Centrum Badan Klinicznych P.I. House Sp. z o.o.

    Gdansk

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Centrum Medyczne All-Med

    Krakow

  • Dermoklinika

    Lodz

  • NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

    Lodz

  • KO-MED Centra Kliniczne Lublin II

    Lublin

  • Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

    Lublin

  • Centrum Medyczne Medyk

    Rzeszów

  • Laser Clinic S.C.

    Szczecin

  • Nasz Lekarz Przychodnie Medyczne

    Torun

  • Clinical Research Group Sp. z o.o.

    Warsaw

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    Wroclaw

Other trials in Poland

Canada7 sites

  • Le centre de Recherche en Dermatologie du Drummondville

    Drummondville, Quebec, J2B 5L4

  • Alberta DermaSurgery Centre

    Edmonton, Alberta

  • Lynderm Research Inc.

    Markham, Ontario, L3P 1X2

  • ICLS Dermatology and Plastic Surgery

    Oakville, Ontario, L6J 7W5

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1G 6C6

  • Centre de Recherche Dermatologique du Quebec Metropolitain

    Québec, Quebec, G1V 4X7

  • Windsor Clinical Research Inc.

    Windsor, Ontario, N8W 5L7

Other trials in Canada

Czechia6 sites

  • CCR Brno, s.r.o.

    Brno

  • CCR Czech, a.s.

    Pardubice

  • CLINTRIAL s.r.o.

    Prague

  • Dermatovenereology

    Prague

  • Fakultni nemocnice v Motole

    Prague

  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

    Ústí nad Labem

Other trials in Czechia

United Kingdom5 sites

  • MAC UK Neuroscience Ltd / MAC Clinical Research Ltd

    Cannock, Staffordshire, WS11 0BN

  • Ninewells Hospital

    Dundee

  • MAC UK Neurosciences Ltd / MAC Clinical Research

    Manchester, Greater Manchester, M13 9NQ

  • Royal Victoria Infirmary

    Newcastle upon Tyne

  • Churchill Hospital

    Oxford

Other trials in United Kingdom

About this study

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

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).

Being tested
Etokimab, Placebo
Keywords
ANB020, etokimab, eczema, moderate to severe
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtokimabBiological

    Also called ANB020

    Humanized monoclonal antibody, administered by subcutaneous injection

  • PlaceboDrug

    Administered by subcutaneous injection

Study groups in NCT03533751
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.
Receives: Drug: Placebo
Etokimab 20 mg SC Q4WExperimentalParticipants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
Receives: Biological: Etokimab
Etokimab 300 mg load + 150 mg SC Q8WExperimentalParticipants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.
Receives: Biological: Etokimab; Drug: Placebo
Etokimab 300 mg load + 150 mg SC Q4WExperimentalParticipants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
Receives: Biological: Etokimab
Etokimab 600 mg load + 300 mg SC Q4WExperimentalParticipants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
Receives: Biological: Etokimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and Week 16

Secondary outcomes (10)

  1. 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).

    Measured: Baseline and Week 16

  2. 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).

    Measured: Baseline and Week 16

  3. 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).

    Measured: Baseline and Week 16

  4. 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

    1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting
    2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting
    3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present
    4. 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.

    Measured: Baseline and Week 16

  5. 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

    1. Almost clear - Barely perceptible erythema, barely perceptible induration/papulation, and/or minimal lichenification. No oozing or crusting
    2. Mild - Slight but definite erythema (pink), slight but definite induration/papulation, and/or slight but definite lichenification. No oozing or crusting
    3. Moderate - Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present
    4. 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.

    Measured: Week 16

  6. 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.

    Measured: Baseline and Week 16

  7. 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.

    Measured: Baseline and Week 16

  8. 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).

    Measured: Baseline and Week 16

  9. 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.

    Measured: Baseline and Week 16

  10. 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.

    Measured: From first dose to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2018
  2. Study start19 Jun 2018
  3. Primary completion3 Dec 2019
  4. Study completion3 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03533751
Sponsor's protocol ID
ANB020-005
Other IDs
2018-000331-27, 2018
Acronym
ATLAS
Status last verified
Apr 2023
First submitted
27 Apr 2018
Last updated
24 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etokimab in people with Atopic Dermatitis, run by AnaptysBio, Inc. at 81 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Germany, Poland, Canada, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03533751.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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