A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis; Eczema; Eczema Atopic Dermatitis; Dermatologic Disease; Atopic; Dermatitis; Eczema, Atopic
• Interventions: Drug: Camoteskimab; Drug: Placebo

• Registration Number: NCT06436183
• Lead Sponsor: Apollo Therapeutics Ltd

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-09
• Study Start: 2024-05-01
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-02
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	Camoteskimab	Camoteskimab
Dose 2	Camoteskimab	Camoteskimab
Dose 2	Placebo	Camoteskimab
Placebo	Placebo	Dummy version of the study drug

Primary Outcome Measures

Name	Time	Method
To compare the clinical efficacy of camoteskimab with placebo in participants with AD	16 weeks	Percentage change from baseline in Eczema Area and Severity Index between camoteskimab and placebo at Week 16

Secondary Outcome Measures

Name	Time	Method
Change from baseline in EASI score at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	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).
Change from baseline & change from W16 in EASI score at W20, 24, 28, 32	Up to 32 weeks	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).
Vital Signs Assessments - Temperature	Through study completion, an average of 36 weeks	Temperature in Celsius will be measured to assess the safety of camoteskimab versus placebo in participants with AD
Change from baseline in AD involvement by BSA at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	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.
Change from baseline in SP-NRS at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.
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	Up to 16 weeks	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).
Change from baseline in DLQI score at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly	Up to 32 weeks	To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Change from baseline & change from W16 in SP-NRS at W20, 24, 28, 32	Up to 32 weeks	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.
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	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.
Change from baseline in peak pruritus score at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Percent change from baseline in EASI score at Weeks 2, 4, 8, 12 and 16	Up to 16 weeks	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).
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Change from baseline in POEM score at Weeks 2, 4, 8, 12, and 16	Up to 16 weeks	To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
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	Up to 32 weeks	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).
Proportion of participants with an IGA 0/1 & a decrease in IGA of ≥ 2 points at W20, 24, 28, 32	Up to 32 weeks	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.
Vital Signs Assessments - O2 Saturation	Through study completion, an average of 36 weeks	O2 saturation (%) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
Change from baseline & change from W16 in peak pruritus score at W20, 24, 28, 32	Up to 32 weeks	To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
Change from baseline & change from W16 in POEM score at W20, 24, 28, 32	Up to 32 weeks	To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
Change from baseline & change from W16 in PROMIS-SRI-SF-8a score at W20, 24, 28, 32	Up to 32 weeks	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.
Physical examinations	Through study completion, an average of 36 weeks	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
Vital Signs Assessments - Blood Pressure	Through study completion, an average of 36 weeks	Systolic and diastolic blood pressure (mmHg) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
Vital Signs Assessments - Pulse	Through study completion, an average of 36 weeks	Pulse (beats/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
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)	Through study completion, an average of 36 weeks	To assess the PK of camoteskimab in participants with AD
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)	Through study completion, an average of 36 weeks	To assess the PK of camoteskimab in participants with AD
Change from baseline in PROMIS-SRI-SF-8a score at Weeks 2, 4, 8, 12, and 16 reported outcomes	Up to 16 weeks	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.
Percent change from baseline & change from W16 in EASI score at W20, 24, 28, 32	Up to 32 weeks	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).
Change from baseline & change from W16 in DLQI score at W20, 24, 28, 32	Up to 32 weeks	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.
Change from baseline & change from W16 in AD involvement by BSA at W20, 24, 28, 32	Up to 32 weeks	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.
ECGs	Through study completion, an average of 36 weeks	PR, QRS, QT, and QTc(F) intervals will be collected to assess the safety of camoteskimab versus placebo in participants with AD
ECGs - Heart Rate	Through study completion, an average of 36 weeks	Heart rate will be collected to assess the safety of camoteskimab versus placebo in participants with AD
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)	Through study completion, an average of 36 weeks	To assess the PK of camoteskimab in participants with AD
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	Through study completion, an average of 36 weeks	All AEs and SAEs will be collected to assess the safety of camoteskimab versus placebo in participants with AD
Vital Signs Assessments - Respiratory Rate	Through study completion, an average of 36 weeks	Respiratory rate (breaths/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD

Trial Locations

Locations (35)

Renaissance Research and Medical Group; 🇺🇸 Cape Coral, Florida, United States

Medical Dermatology Specialists, PC/US Dermatology Partners; 🇺🇸 Phoenix, Arizona, United States

California Dermatology & Clinical Research Institute; 🇺🇸 Encinitas, California, United States

First OC Dermatology Research, Inc.; 🇺🇸 Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

California Allergy and Asthma Medical Group; 🇺🇸 Los Angeles, California, United States

University of California Los Angeles Dermatology; 🇺🇸 Los Angeles, California, United States

Amicis Research Center (Northridge); 🇺🇸 Northridge, California, United States

Cura Clinical Research; 🇺🇸 Oxnard, California, United States

VASDHS - Veterans Affairs San Diego Medical Center; 🇺🇸 San Diego, California, United States

Clinical Sciences Institute; 🇺🇸 Santa Monica, California, United States

D&H National Research Centers, Inc.; 🇺🇸 Miami, Florida, United States

Avita Clinical Research - Dermatology; 🇺🇸 Tampa, Florida, United States

Sneeze, Wheeze & Itch Associates, LLC; 🇺🇸 Normal, Illinois, United States

Dawes Fretzin Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

Skin Sciences, PLLC; 🇺🇸 Louisville, Kentucky, United States

Owensboro Dermatology Associates; 🇺🇸 Owensboro, Kentucky, United States

Revival Research Institute; 🇺🇸 Troy, Michigan, United States

Somerset Skin Centre; 🇺🇸 Troy, Michigan, United States

Michigan Dermatology Institute; 🇺🇸 Waterford, Michigan, United States

Advanced Dermatology and Skin Cancer Center - Saint Joseph; 🇺🇸 Saint Joseph, Missouri, United States

Skin Specialists PC; 🇺🇸 Omaha, Nebraska, United States

M3 Wake Research, Inc.; 🇺🇸 Raleigh, North Carolina, United States

ObjectiveHealth-The Skin Surgery Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Central Sooner Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Unity Clinical Research - Dermatology; 🇺🇸 Oklahoma City, Oklahoma, United States

Paddington Testing Co. Inc; 🇺🇸 Philadelphia, Pennsylvania, United States

Rodgers Dermatology; 🇺🇸 Frisco, Texas, United States

Center for Clinical Studies; 🇺🇸 Houston, Texas, United States

Clinical Trial Network; 🇺🇸 Houston, Texas, United States

Youthful Image; 🇨🇦 Edmonton, Alberta, Canada

Rejuvenation Dermatology Clinic Edmonton South; 🇨🇦 Edmonton, Alberta, Canada

Kingsway Clinical Research; 🇨🇦 Etobicoke, Ontario, Canada

Clinique Medicale Saint-Louis; 🇨🇦 Québec, Quebec, Canada

Clinique Dermatologique de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada