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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000331-27 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks. |
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| Etokimab 20 mg SC Q4W | Experimental | Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks. |
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| Etokimab 300 mg load + 150 mg SC Q8W | Experimental | Participants 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. |
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| Etokimab 300 mg load + 150 mg SC Q4W | Experimental | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
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| Etokimab 600 mg load + 300 mg SC Q4W | Experimental | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etokimab | Biological | Humanized monoclonal antibody, administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Randazzo, MD | AnaptysBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Applied Research Center of Arkansas |
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| Label | URL |
|---|---|
| Related Info | View source |
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Participants were equally randomized on Day 1 to one of five treatment groups.
This study was conducted at 75 centers in the United States, United Kingdom, Canada, Czech Republic, Germany, and Poland. The study enrolled adults with moderate to severe atopic dermatitis (AD).
The study included a treatment period of 16 weeks (Week 0 to 16) followed by a safety follow-up for 8 weeks (Week 16 to Week 24).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks. |
| FG001 | Etokimab 20 mg SC Q4W | Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2019 | Mar 29, 2023 |
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| Placebo | Drug | Administered by subcutaneous injection |
|
| Baseline and Week 16 |
| 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 |
| 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 |
| 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
Number of participants with ≥2 points reduction in vIGA-AD is presented. | Baseline and Week 16 |
| 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
| Week 16 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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:
| From first dose to Week 24 |
| Little Rock |
| Arkansas |
| 72212 |
| United States |
| Encino Research Group | Encino | California | 91436 | United States |
| Irvine Center for Clinical Research, Inc. | Irvine | California | 92614 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Medical Research Center of Miami | Miami | Florida | 33134 | United States |
| Compass Research Main | Orlando | Florida | 32806 | United States |
| Moore Clinical Research Inc. - Brandon | Tampa | Florida | 33609 | United States |
| Georgia Pollens Clinical Research Centers, Inc. | Albany | Georgia | 31707 | United States |
| Dermatologic Surgery Specialists | Macon | Georgia | 31217 | United States |
| Marietta Dermatology & The Skin Cancer Center - Marietta | Marietta | Georgia | 30060-1047 | United States |
| Advanced Medical Research, PC | Sandy Springs | Georgia | 30328 | United States |
| Midwest Allergy, Sinus and Asthma, SC | Normal | Illinois | 61761 | United States |
| Kansas City Dermatology, PA | Overland Park | Kansas | 66215-2314 | United States |
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215-5400 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Grekin Skin Institute - Warren | Warren | Michigan | 48088 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63141 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| JDR Dermatology Research | Las Vegas | Nevada | 89148 | United States |
| The Dermatology Group | Verona | New Jersey | 07044-2946 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | United States |
| SRG | New York | New York | 10021 | United States |
| DermResearch Center of New York | Stony Brook | New York | 11790 | United States |
| Wilmington Dermatology Center | Wilmington | North Carolina | 28403 | United States |
| Ohio State University Clinical Trials Management Office | Columbus | Ohio | 43210 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Coppell Allergy and Asthma PA | Coppell | Texas | 75019 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Center for Medical Research | Houston | Texas | 77056 | United States |
| Progressive Clinical Research, PA | San Antonio | Texas | 78213 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | United States |
| Alberta DermaSurgery Centre | Edmonton | Alberta | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| ICLS Dermatology and Plastic Surgery | Oakville | Ontario | L6J 7W5 | Canada |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1G 6C6 | Canada |
| Windsor Clinical Research Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| Le centre de Recherche en Dermatologie du Drummondville | Drummondville | Quebec | J2B 5L4 | Canada |
| Centre de Recherche Dermatologique du Quebec Metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| CCR Brno, s.r.o. | Brno | Czechia |
| CCR Czech, a.s. | Pardubice | Czechia |
| CLINTRIAL s.r.o. | Prague | Czechia |
| Dermatovenereology | Prague | Czechia |
| Fakultni nemocnice v Motole | Prague | Czechia |
| Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. | Ústà nad Labem | Czechia |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Klinikum der Ludwigs-Maximilians-Universitaet Muenchen | Munich | Bavaria | 80337 | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt am Main | Hesse | 60590 | Germany |
| Fachklinik Bad Bentheim Dermatologie | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Lower Saxony | 1307 | Germany |
| Universitaetsklinikum Bonn AoeR | Bonn | North Rhine-Westphalia | 53105 | Germany |
| Universitaetsklinikum Leipzig AoeR | Leipzig | Saxony | 4103 | Germany |
| Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| Universitaetsklinikum Schleswig Holstein - Campus Luebeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| SRH Wald-Klinikum Gera gGmbH | Gera | Thuringia | 7548 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | 10117 | Germany |
| Praxis fuer Haut- und Geschlechtskrankheiten | Berlin | 13055 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| ClinicMed Daniluk, Nowak Spółka Jawna | Bialystok | Poland |
| Centrum Badan Klinicznych P.I. House Sp. z o.o. | Gdansk | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Centrum Medyczne All-Med | Krakow | Poland |
| Dermoklinika | Lodz | Poland |
| NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie | Lodz | 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. | Warsaw | Poland |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu | Wroclaw | Poland |
| MAC UK Neurosciences Ltd / MAC Clinical Research | Manchester | Greater Manchester | M13 9NQ | United Kingdom |
| MAC UK Neuroscience Ltd / MAC Clinical Research Ltd | Cannock | Staffordshire | WS11 0BN | United Kingdom |
| Ninewells Hospital | Dundee | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom |
| Churchill Hospital | Oxford | United Kingdom |
| FG002 | Etokimab 300 mg / 150 mg SC Q8W | Participants 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. |
| FG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| FG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks. |
| BG001 | Etokimab 20 mg SC Q4W | Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks. |
| BG002 | Etokimab 300 mg / 150 mg SC Q8W | Participants 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. |
| BG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| BG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eczema Area and Severity Index (EASI) | 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). | The Full Analysis Set included all randomized participants who received at least 1 dose of etokimab or placebo and had Baseline and post-baseline EASI scores. Number of participants with evaluable data were included. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) | The vIGA-AD is a 5-point scale to evaluate AD severity:
| Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Full Analysis Set. Missing data were imputed using multiple imputation. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 16 |
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| 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). | Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Baseline and Week 16 |
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| 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). | Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Baseline and Week 16 |
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| 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). | Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Baseline and Week 16 |
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| 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
Number of participants with ≥2 points reduction in vIGA-AD is presented. | Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Baseline and Week 16 |
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| 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
| Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Week 16 |
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| 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. | Full Analysis Set. Participants with missing data were counted as non-responders. | Posted | Count of Participants | Participants | Baseline and Week 16 |
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| 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. | Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 16 |
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| 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). | Full Analysis Set. Missing data were imputed using multiple imputation. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 16 |
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| 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. | Full Analysis Set with available data were analyzed. Missing data were imputed using multiple imputation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 16 |
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| 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:
| Safety Analysis Set | Posted | Count of Participants | Participants | From first dose to Week 24 |
|
From first dose to Week 24
Safety Analysis Set
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received matching placebo to etokimab, administered SC Q4W for up to 16 weeks. | 0 | 60 | 1 | 60 | 24 | 60 |
| EG001 | Etokimab 20 mg SC Q4W | Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks. | 0 | 61 | 2 | 61 | 22 | 61 |
| EG002 | Etokimab 300 mg / 150 mg SC Q8W | Participants 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. | 0 | 59 | 3 | 59 | 23 | 59 |
| EG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. | 0 | 60 | 3 | 60 | 18 | 60 |
| EG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. | 0 | 60 | 3 | 60 | 26 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
| |
| Troponin I Increased | Investigations | MedDRA (22.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Joint Instability | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis Exfoliative Generalized | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Eczema Herpeticum | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader | AnaptysBio, Inc. | 858-362-6295 | info@anaptysbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2019 | Mar 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
|
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| ANCOVA |
The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate. |
| 0.5010 |
| LS Mean Difference |
| -6.32 |
| Standard Error of the Mean |
| 9.390 |
| 2-Sided |
| 95 |
| -24.7740 |
| 12.1262 |
Difference = Etokimab - Placebo |
| Superiority |
| ANCOVA | The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate. | 0.8349 | LS Mean Difference | 1.97 | Standard Error of the Mean | 9.454 | 2-Sided | 95 | -16.6037 | 20.5476 | Difference = Etokimab - Placebo | Superiority |
| ANCOVA | The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate. | 0.6662 | LS Mean Difference | 4.82 | Standard Error of the Mean | 11.154 | 2-Sided | 95 | -17.1892 | 26.8275 | Difference = Etokimab - Placebo | Superiority |
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
Participants received etokimab 20 mg administered SC Q4W for up to 16 weeks.
| OG002 | Etokimab 300 mg / 150 mg SC Q8W | Participants 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. |
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| OG002 | Etokimab 300 mg / 150 mg SC Q8W | Participants 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. |
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| Etokimab 300 mg / 150 mg SC Q4W |
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| Etokimab 300 mg / 150 mg SC Q4W |
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| Etokimab 300 mg / 150 mg SC Q8W |
Participants 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. |
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
Participants 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.
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
|
|
| OG003 | Etokimab 300 mg / 150 mg SC Q4W | Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks. |
| OG004 | Etokimab 600 mg / 300 mg SC Q4W | Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks. |
|
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