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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06436183
Other study ID # AP43CP03
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source Apollo Therapeutics Ltd
Contact Apollo Therapeutics
Phone +1 781 479 2267
Email AP43@apollotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.


Description:

This study contains two parts: Parts 1 and Part 2. Part 1 (Blinded Period): Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo. Part 2 (Extension Period): In part 2, all participants will receive camoteskimab.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Participants must be 18-75 years of age inclusive, at the time of signing the informed consent. 2. Chronic AD for at least 1 year. 3. Participants with moderate to severe AD defined by: 1. Investigator global assessment (IGA) score of = 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Baseline. 2. AD involvement of = 10% body surface area (BSA) at Baseline. 3. EASI score of = 12 at Baseline. 4. Pruritus numerical rating scale (NRS) = 4 at Baseline. 4. Participants who are candidates for systemic therapy, defined as inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable. 5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants: - Sexually active females of childbearing potential must agree to use two forms of accepted methods of highly effective forms of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes: - IUD plus one barrier method. - Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method. - 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or - A vasectomized partner*. Male participants: - Sexually active male participants and males and who are partners of females of childbearing potential agree to use two forms of contraception as above and to not donate sperm or try to conceive during the treatment period and for at least 3 months after the last dose of study drug. 6. Participant provides signed informed consent. Exclusion Criteria: 1. Participant has history of use of more than two (2) prior systemic therapies for AD (e.g. biologics or JAKi) and who used any of these medications as follows: 1. Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline. 2. Systemic JAKi within 4 weeks prior to Baseline. 3. TCS, TCI, topical phosphodiesterase-4 (PDE4) inhibitors, and topical JAKi within 7 days prior to enrollment (at Baseline) or more than five half-lives whichever is longer. 2. Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments. 3. Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma). 4. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with the interpretation of QTc interval changes. 5. Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, or keratitis diagnosed within the last 60 days prior to the screening visit, requiring chronic ocular corticosteroid treatment. 6. Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or any other non-AD disease as judged by the Investigator. Participants with seasonal or allergic rhinitis, asthma or any other non-AD disease requiring use of intranasal or inhaled corticosteroid that is stable and well-controlled are not excluded. 7. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Active hepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence of active or latent TB 8. Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of - Completely resected basal call or squamous cell carcinoma of the skin. - Carcinoma in situ of the cervix. 9. Has had previous exposure to anti-IL-18 therapy. 10. Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening. 11. Has any of the following laboratory findings 1. Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2. 2. Hemoglobin =8 g/dL. 3. Neutrophils =1,500/µL. 4. Platelets =75,000/µL.

Study Design


Intervention

Drug:
Camoteskimab
Drug Product
Placebo
Inactive substance

Locations

Country Name City State
Canada Rejuvenation Dermatology Clinic Edmonton South Edmonton Alberta
Canada Youthful Image Edmonton Alberta
Canada Kingsway Clinical Research Etobicoke Ontario
Canada Ottawa Allergy Research Corporation Ottawa Ontario
Canada Clinique Medicale Saint-Louis Québec Quebec
Canada Clinique Dermatologique de Sherbrooke Sherbrooke Quebec
United States University Hospitals Case Medical Center Cleveland Ohio
United States California Dermatology & Clinical Research Institute Encinitas California
United States Floridian Research Institute, Llc Fort Myers Florida
United States Rodgers Dermatology Frisco Texas
United States Center for Clinical Studies Houston Texas
United States Clinical Trial Network Houston Texas
United States Dawes Fretzin Clinical Research Indianapolis Indiana
United States California Allergy and Asthma Medical Group Los Angeles California
United States Keck School of Medicine of USC Los Angeles California
United States Skin Sciences, Pllc Louisville Kentucky
United States D&H National Research Centers, Inc. Miami Florida
United States Sneeze, Wheeze & Itch Associates, LLC Normal Illinois
United States Central Sooner Research Oklahoma City Oklahoma
United States Skin Specialists PC Omaha Nebraska
United States Owensboro Dermatology Associates Owensboro Kentucky
United States Paddington Testing Co. Inc Philadelphia Pennsylvania
United States Medical Dermatology Specialists, PC/US Dermatology Partners Phoenix Arizona
United States M3 Wake Research, Inc. Raleigh North Carolina
United States Advanced Dermatology and Skin Cancer Center - Saint Joseph Saint Joseph Missouri
United States VASDHS - Veterans Affairs San Diego Medical Center San Diego California
United States GCP Clinical Research Tampa Florida
United States Somerset Skin Centre Troy Michigan

Sponsors (1)

Lead Sponsor Collaborator
Apollo Therapeutics Ltd

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the clinical efficacy of camoteskimab with placebo in participants with AD Percentage change from baseline in Eczema Area and Severity Index between camoteskimab and placebo at Week 16 16 weeks
Secondary Percent change from baseline in EASI score at Weeks 2, 4, 8, 12 and 16 To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 16 weeks
Secondary Change from baseline in EASI score at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 16 weeks
Secondary Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 16 weeks
Secondary Proportion of participants with an IGA 0/1 and a decrease in IGA of = 2 points at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity. Up to 16 weeks
Secondary Change from baseline in peak pruritus score at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. Up to 16 weeks
Secondary Proportion of participants with an improvement of = 4 or more points in peak pruritus weekly score at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. Up to 16 weeks
Secondary Change from baseline in POEM score at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems. Up to 16 weeks
Secondary Change from baseline in DLQI score at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life. Up to 16 weeks
Secondary Change from baseline in AD involvement by BSA at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD. Up to 16 weeks
Secondary Change from baseline in SP-NRS at Weeks 2, 4, 8, 12, and 16 To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain. Up to 16 weeks
Secondary Change from baseline in PROMIS-SRI-SF-8a score at Weeks 2, 4, 8, 12, and 16 reported outcomes To further assess the efficacy of camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being. Up to 16 weeks
Secondary Percent change from baseline & change from W16 in EASI score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 32 weeks
Secondary Change from baseline & change from W16 in EASI score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 32 weeks
Secondary Proportion of participants achieving a 50, 75, 90 & 100% improvement from baseline line in EASI (EASI-50, 75, 90 & 100) at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). Up to 32 weeks
Secondary Proportion of participants with an IGA 0/1 & a decrease in IGA of = 2 points at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity. Up to 32 weeks
Secondary Change from baseline & change from W16 in peak pruritus score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. Up to 32 weeks
Secondary Proportion of participants with an improvement of = 4 or more points in peak pruritus weekly To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. Up to 32 weeks
Secondary Change from baseline & change from W16 in POEM score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems. Up to 32 weeks
Secondary Change from baseline & change from W16 in DLQI score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life. Up to 32 weeks
Secondary Change from baseline & change from W16 in AD involvement by BSA at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD. Up to 32 weeks
Secondary Change from baseline & change from W16 in SP-NRS at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain. Up to 32 weeks
Secondary Change from baseline & change from W16 in PROMIS-SRI-SF-8a score at W20, 24, 28, 32 To assess the efficacy of extended treatment with camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being. Up to 32 weeks
Secondary All AEs and SAEs will be collected from the signing of the ICF until the EOS visit and all SAEs will be collected from the signing of the ICF until 3 months after the last dose of IMP All AEs and SAEs will be collected to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Physical examinations A general PE or symptom directed PE will be performed and abnormalities will be recorded and reported as AEs if appropriate to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Vital Signs Assessments - Temperature Temperature in Celsius will be measured to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Vital Signs Assessments - Blood Pressure Systolic and diastolic blood pressure (mmHg) will be measured to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Vital Signs Assessments - Pulse Pulse (beats/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Vital Signs Assessments - Respiratory Rate Respiratory rate (breaths/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary Vital Signs Assessments - O2 Saturation O2 saturation (%) will be measured to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary ECGs PR, QRS, QT, and QTc(F) intervals will be collected to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary ECGs - Heart Rate Heart rate will be collected to assess the safety of camoteskimab versus placebo in participants with AD Through study completion, an average of 36 weeks
Secondary PK sampling of unbound camoteskimab in nanograms per milliliter for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225) To assess the PK of camoteskimab in participants with AD Through study completion, an average of 36 weeks
Secondary PK Total LCMS sampling in ng/mL to determine camoteskimab exposures in the body over time for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225) To assess the PK of camoteskimab in participants with AD Through study completion, an average of 36 weeks
Secondary PK Total Immunoassay sampling (sum of bound and free) in ng/mL for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225) To assess the PK of camoteskimab in participants with AD Through study completion, an average of 36 weeks
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