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

NCT06436183 | Completed Phase 2 FDA Drug

• 1 other identifier: AP43CP03
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 35

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.

Conditions

Atopic Dermatitis; Atopic; Dermatitis; Dermatologic Disease; Eczema; Eczema Atopic Dermatitis; Eczema, Atopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Percent change from baseline in EASI score at Week 12

  12 Weeks

• Change from baseline in EASI score at Week 12

  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

  12 weeks

• Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12

  12 weeks

• Change from baseline in peak pruritus score at Week 12

  12 weeks

Study Arms (3)

Dose 1

EXPERIMENTAL

Camoteskimab

Drug: Camoteskimab

Dose 2

EXPERIMENTAL

Camoteskimab

Drug: Camoteskimab; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Dummy version of the study drug

Drug: Placebo

Interventions

Camoteskimab DRUG

Drug Product

Also known as: APL-9109, AVTX-007, CERC-007, AEVI-007, MEDI2338

Dose 1; Dose 2

Placebo DRUG

Inactive substance

Dose 2; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year.
• Participants with moderate to severe AD defined by:
• 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.
• AD involvement of ≥ 10% body surface area (BSA) at Baseline.
• EASI score of ≥ 12 at Baseline.
• Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.
• 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.
• 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.
• 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\*.

You may not qualify if:

• 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:
• Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
• Systemic JAKi within 4 weeks prior to Baseline.
• 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.
• 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.
• Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
• 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.
• 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.
• 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.
• 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
• 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.
• Has had previous exposure to anti-IL-18 therapy.

Sponsors & Collaborators

• Apollo Therapeutics Ltd: lead

Study Sites (35)

Medical Dermatology Specialists, PC/US Dermatology Partners

Phoenix, Arizona, 85006, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

Location

First OC Dermatology Research, Inc.

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

University of California Los Angeles Dermatology

Los Angeles, California, 90095, United States

Location

Amicis Research Center (Northridge)

Northridge, California, 91324, United States

Location

Cura Clinical Research

Oxnard, California, 93030, United States

Location

VASDHS - Veterans Affairs San Diego Medical Center

San Diego, California, 92161, United States

Location

Clinical Sciences Institute

Santa Monica, California, 90404, United States

Location

Renaissance Research and Medical Group

Cape Coral, Florida, 33991, United States

Location

D&H National Research Centers, Inc.

Miami, Florida, 33155, United States

Location

Avita Clinical Research - Dermatology

Tampa, Florida, 33613, United States

Location

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46250, United States

Location

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 28329, United States

Location

Advanced Dermatology and Skin Cancer Center - Saint Joseph

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists PC

Omaha, Nebraska, 68144, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

ObjectiveHealth-The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73071, United States

Location

Unity Clinical Research - Dermatology

Oklahoma City, Oklahoma, 73118, United States

Location

Paddington Testing Co. Inc

Philadelphia, Pennsylvania, 19103, United States

Location

Rodgers Dermatology

Frisco, Texas, 75034, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Youthful Image

Edmonton, Alberta, T5J 3S9, Canada

Location

Rejuvenation Dermatology Clinic Edmonton South

Edmonton, Alberta, T6W 0J5, Canada

Location

Kingsway Clinical Research

Etobicoke, Ontario, M8X 1Y9, Canada

Location

Clinique Medicale Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Clinique Dermatologique de Sherbrooke

Sherbrooke, Quebec, J1G 1X9, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Skin Diseases; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 30, 2024
• Study Start: May 1, 2024
• Primary Completion: March 26, 2025
• Study Completion: August 12, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-05

Locations

US (30); CA (5)