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Etokimab

Phase 2

Atopic Dermatitis | Monoclonal antibody | Dermatology |AnaptysBio, Inc.|Last Updated: Aug 16, 2023

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment302
FDA Designations
No designations recorded
Clinical trial landscape

Etokimab · 4 trials · 4 indications

Phase 2 4
NCT03614923Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Chronic Rhinosinusitis
COMPLETED105 Analytics
NCT03533751Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic DermatitisAtopic Dermatitis
COMPLETED302 Analytics
NCT03469934Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic AsthmaEosinophilic Asthma
COMPLETED25 Analytics
NCT02920021Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut AllergyPeanut Allergy
COMPLETED20 Analytics
PHASE2COMPLETED
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Chronic RhinosinusitisUnlock trial analytics
PHASE2COMPLETED
Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis
Atopic DermatitisUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Eosinophilic AsthmaUnlock trial analytics
PHASE2COMPLETED
Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy
Peanut AllergyUnlock trial analytics
Study Endpoints
Primary Endpoints
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
Baseline and Week 16

Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer. Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity. The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement.

Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
Baseline and Week 16

SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement.

Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
Baseline and 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).

Change From Baseline in Peripheral Eosinophil Count at Day 22
Baseline, Day 22
Number of Participants With Treatment-Emergent Adverse Events
From first dose to Day 127

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.

Number of Asthma Exacerbations
From first dose to Day 127

Asthma exacerbation was defined as follows: 1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. OR 2. An emergency room/urgent care visit (defined as evaluation and treatment for \<24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). OR 3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).

Number of Participants With Positive Anti-drug Antibody
Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From first dose of study drug up to 45 days.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AEs include any clinical laboratory test results determined to be clinically significant by the investigator. AE was considered "serious" if there was any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Each AE was evaluated for severity (mild, moderate, or severe) and causal relationship to the study drug. AE was considered TEAE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.

Change From Baseline in Cumulative Tolerated Peanut Dose During Oral Food Challenge
Baseline and Day 14

Oral food challenges were performed at Baseline and Day 14 in accordance with the Practical Allergy (PRACTALL) consensus report. Escalating doses of peanut protein (peanut flour mixed with a non-allergic food vehicle such as apple sauce) consisting of 5, 20, 50, 100, 100, 100, and 125 mg (for a cumulative maximum dose of 500 mg) were given at 20 minute intervals. If the participant developed any signs of an objective allergic reaction, the challenge was stopped. The total cumulative tolerated dose of blinded peanut reached prior to reaction was recorded.

Secondary Endpoints
Change From Baseline in Eosinophil Count
Baseline, Week 16, and Week 24
Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16
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
Baseline and Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Etokimab 300 mg + 150 mg Q4WEXPERIMENTALParticipants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID).
Etokimab 300 mg + 150 mg Q8WEXPERIMENTALParticipants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
PlaceboPLACEBO_COMPARATORParticipants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID.
Etokimab 20 mg SC Q4WEXPERIMENTALParticipants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
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.
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.
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.
EtokimabEXPERIMENTALParticipants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks.
Interventions
NameTypeDescription
EtokimabBIOLOGICALAdministered by subcutaneous injection
PlaceboBIOLOGICALAdministered by subcutaneous injection
Mometasone Furoate Nasal SprayDRUGMometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg.
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Clinically confirmed diagnosis of CRSwNP * Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril). * 22 Item Sino-Nasal Outcome Test (SNOT-22) score \> 15. * Presence of at least two of the following symptoms prior to...

Countries:United StatesCanadaCzechiaGermanyPolandUnited Kingdom
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