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

Atopic Dermatitis Clinical Trial

Official title:

A Phase 2a, Multicenter, Randomized, Double-blind, 16-week Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436183
• Other study ID #: AP43CP03
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Atopic
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dermatologic Disease
• Eczema
• Eczema Atopic Dermatitis
• Eczema, Atopic
• Skin Diseases

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