COMPLETED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-05-01

Study Completion:2025-08-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06436183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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\. 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.	1. Participant has history of use of more than two (2) prior systemic therapies for AD (e.g. 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.

Inclusion Criteria

Exclusion 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.
* 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\*.
* 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.

1. Participant has history of use of more than two (2) prior systemic therapies for AD (e.g.
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.

Contacts and Locations

Study Locations (Sites)

Medical Dermatology Specialists, PC/US Dermatology Partners

Phoenix, Arizona, 85006

United States

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

United States

First OC Dermatology Research, Inc.

Fountain Valley, California, 92708

United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538

United States

California Allergy and Asthma Medical Group

Los Angeles, California, 90025

United States

University of California Los Angeles Dermatology

Los Angeles, California, 90095

United States

Amicis Research Center (Northridge)

Northridge, California, 91324

United States

Cura Clinical Research

Oxnard, California, 93030

United States

VASDHS - Veterans Affairs San Diego Medical Center

San Diego, California, 92161

United States

Clinical Sciences Institute

Santa Monica, California, 90404

United States

Renaissance Research and Medical Group

Cape Coral, Florida, 33991

United States

D&H National Research Centers, Inc.

Miami, Florida, 33155

United States

Avita Clinical Research - Dermatology

Tampa, Florida, 33613

United States

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761

United States

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46250

United States

Skin Sciences, PLLC

Louisville, Kentucky, 40217

United States

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303

United States

Revival Research Institute

Troy, Michigan, 48084

United States

Somerset Skin Centre

Troy, Michigan, 48084

United States

Michigan Dermatology Institute

Waterford, Michigan, 28329

United States

Advanced Dermatology and Skin Cancer Center - Saint Joseph

Saint Joseph, Missouri, 64506

United States

Skin Specialists PC

Omaha, Nebraska, 68144

United States

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612

United States

ObjectiveHealth-The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103

United States

Central Sooner Research

Oklahoma City, Oklahoma, 73071

United States

Unity Clinical Research - Dermatology

Oklahoma City, Oklahoma, 73118

United States

Paddington Testing Co. Inc

Philadelphia, Pennsylvania, 19103

United States

Rodgers Dermatology

Frisco, Texas, 75034

United States

Center for Clinical Studies

Houston, Texas, 77004

United States

Clinical Trial Network

Houston, Texas, 77074

United States

Collaborators and Investigators

Sponsor: Apollo Therapeutics Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2025-08-12

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2025-08-12

Terms related to this study

Additional Relevant MeSH Terms

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