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

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis; Eczema; Atopic Dermatitis; Atopic; Eczema, Atopic; Dermatologic Disease; Eczema Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Camoteskimab

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Youthful Image
    • Edmonton, Alberta, Canada, T6W 0J5
      • Rejuvenation Dermatology Clinic Edmonton South
  • Ontario
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
  • Quebec
    • Québec, Quebec, Canada, G1W 4R4
      • Clinique Medicale Saint-Louis
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Clinique Dermatologique de Sherbrooke
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists, PC/US Dermatology Partners
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology Research, Inc.
    • Fremont, California, United States, 94538
      • Center For Dermatology Clinical Research, Inc.
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Dermatology
    • Northridge, California, United States, 91324
      • Amicis Research Center (Northridge)
    • Oxnard, California, United States, 93030
      • Cura Clinical Research
    • San Diego, California, United States, 92161
      • VASDHS - Veterans Affairs San Diego Medical Center
    • Santa Monica, California, United States, 90404
      • Clinical Sciences Institute
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Renaissance Research and Medical Group
    • Miami, Florida, United States, 33155
      • D&H National Research Centers, Inc.
    • Tampa, Florida, United States, 33613
      • Avita Clinical Research - Dermatology
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze & Itch Associates, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Skin Sciences, PLLC
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Dermatology Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
    • Troy, Michigan, United States, 48084
      • Revival Research Institute
    • Waterford, Michigan, United States, 28329
      • Michigan Dermatology Institute
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Advanced Dermatology and Skin Cancer Center - Saint Joseph
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Winston-Salem, North Carolina, United States, 27103
      • ObjectiveHealth-The Skin Surgery Center for Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73071
      • Central Sooner Research
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research - Dermatology
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co. Inc
  • Texas
    • Frisco, Texas, United States, 75034
      • Rodgers Dermatology
    • Houston, Texas, United States, 77004
      • Center For Clinical Studies
    • Houston, Texas, United States, 77074
      • Clinical Trial Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1; Camoteskimab	Drug: Camoteskimab; Drug Product; Other Names: APL-9109; AVTX-007; CERC-007; AEVI-007; MEDI2338
Experimental: Dose 2; Camoteskimab	Drug: Placebo; Inactive substance; Drug: Camoteskimab; Drug Product; Other Names: APL-9109; AVTX-007; CERC-007; AEVI-007; MEDI2338
Placebo Comparator: Placebo; Dummy version of the study drug	Drug: Placebo; Inactive substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12	An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in EASI score at Week 12	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).	12 Weeks
Change from baseline in EASI score at Week 12	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).	12 weeks
Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12	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).	12 weeks
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12	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.	12 weeks
Change from baseline in peak pruritus score at Week 12	To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.	12 weeks
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12	To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.	12 weeks
Change from baseline in POEM score at Week 12	To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.	12 weeks
Change from baseline in DLQI score at Week 12	To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.	12 weeks
Change from baseline in AD involvement by BSA at Week 12	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.	12 weeks
Change from baseline in SP-NRS at Week 12	To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.	12 weeks
Change from baseline in PROMIS-SRI-SF-8a score at Week 12 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.	12 weeks

Collaborators and Investigators

• Sponsor: Apollo Therapeutics Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): August 12, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: AP43CP03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No