A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07599813 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AP43CP04
• Study Type: interventional
• Target: 280
• Locations: 8 countries
• Sites: 85

Brief Summary

This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.

Conditions

Atopic Dermatitis; Atopic; Dermatitis; Dermatitis, Atopic; 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 24

  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.

  From Baseline visit until Week 24 visit

Secondary Outcomes (3)

• Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)

  24 weeks

• Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline

  24 weeks

• Proportion of participants with an improvement of ≥ 4 or more points from baseline in peak pruritus NRS (PP-NRS) weekly average of the daily scores

  24 weeks

Study Arms (4)

Dose 1

EXPERIMENTAL

Camoteskimab

Drug: Camoteskimab

Dose 2

EXPERIMENTAL

Camoteskimab

Drug: Camoteskimab

Dose 3

EXPERIMENTAL

Camoteskimab

Drug: Camoteskimab

Placebo

PLACEBO COMPARATOR

Dummy version of the study drug

Drug: Placebo

Interventions

Camoteskimab DRUG

Drug Product

Also known as: APL-9109

Dose 1; Dose 2; Dose 3

Placebo DRUG

Inactive substance

Placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-65 inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
• 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 Screening and Baseline.
• AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
• EASI score of ≥ 16 at Screening and at Baseline.
• Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed.
• Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant provides signed informed consent

You may not qualify if:

• History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
• Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
• 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 based on the Investigator's judgement.
• Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
• Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
• 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 Investigator that may interfere with the interpretation of QTc interval changes.
• Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
• Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
• Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
• Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
• Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
• Evidence of active or latent tuberculosis.
• Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
• Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
• Participant is known to have immune deficiency or is immunocompromised

Sponsors & Collaborators

• Apollo Therapeutics Ltd: lead

Study Sites (85)

AllerVie Clinical Research

Birmingham, Alabama, 35209, United States

NOT YET RECRUITING

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, 35244, United States

NOT YET RECRUITING

Saguaro Dermatology Associates

Phoenix, Arizona, 85018, United States

NOT YET RECRUITING

Dermatology Trial Associates, Inc

Bryant, Arkansas, 72022, United States

NOT YET RECRUITING

Marvel Research, LLC

Huntington Beach, California, 92648, United States

NOT YET RECRUITING

Metropolis Dermatology

Los Angeles, California, 90025, United States

NOT YET RECRUITING

Dermatology Research Associates

Los Angeles, California, 90048, United States

NOT YET RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Clinical Trials Research Institute

Northridge, California, 91324, United States

NOT YET RECRUITING

Integrative Skin Science and Research

Sacramento, California, 95825, United States

NOT YET RECRUITING

Valiance Clinical Research - Tarzana

Tarzana, California, 91356, United States

NOT YET RECRUITING

Paradigm Clinical Research Centers, LLC: Wheat Ridge

Wheat Ridge, Colorado, 80033, United States

NOT YET RECRUITING

ABMED Clinical Research Corp.

Cape Coral, Florida, 33904, United States

NOT YET RECRUITING

International Dermatology Research, INC

Hollywood, Florida, 33021, United States

NOT YET RECRUITING

Quality Care Clinical Research

Miami, Florida, 33101, United States

NOT YET RECRUITING

FXM Clinical Research Miami, LLC

Miami, Florida, 33155, United States

NOT YET RECRUITING

Eminent Clinical Research and Associates

North Lauderdale, Florida, 33068, United States

NOT YET RECRUITING

Ziaderm Research LLC

North Miami Beach, Florida, 33162, United States

NOT YET RECRUITING

NMC Research LLC

Tampa, Florida, 33614, United States

NOT YET RECRUITING

Elligo - Georgia Skin & Cancer Clinic (Sidney P. Smith, MD, PC)

Savannah, Georgia, 31406, United States

NOT YET RECRUITING

Ada West Research, LLC

Meridian, Idaho, 83642, United States

NOT YET RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

NOT YET RECRUITING

DS Research of Southern Indiana,LLC

Clarksville, Indiana, 47129, United States

NOT YET RECRUITING

Dawes Fretzin Clinical Research Group, LLC

Columbus, Indiana, 47201, United States

NOT YET RECRUITING

Chesapeake Clinical Research, Inc

Pasadena, Maryland, 21122, United States

NOT YET RECRUITING

Mountain west derm blackhart PLLC Dba Skin Cancer and Dermatology Institute

Reno, Nevada, 89502, United States

NOT YET RECRUITING

Trail Horizon

Clifton, New Jersey, 07013, United States

NOT YET RECRUITING

Sadick Research Group, LLC

New York, New York, 10021, United States

RECRUITING

Red River Research Partners, LLC

Fargo, North Dakota, 58103, United States

NOT YET RECRUITING

ClinOhio Research Services

Columbus, Ohio, 43214, United States

NOT YET RECRUITING

Best Skin Research, LLC

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

Progressive Clinical Research, PA

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

Medical Center Medconsult Burgas EOOD

Burgas, Bulgaria

NOT YET RECRUITING

Medical Center Kazanlak EOOD

Kazanlak, Bulgaria

NOT YET RECRUITING

Medical Center Medconsult Pleven-Lovech Branch

Lovech, Bulgaria

NOT YET RECRUITING

Medical Center Medconsult Pleven OOD

Pleven, Bulgaria

NOT YET RECRUITING

Medical Centre Pratia Clinic EOOD

Varna, Bulgaria

NOT YET RECRUITING

Beacon Dermatology

Calgary, Alberta, Canada

NOT YET RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Calgary, Alberta, Canada

NOT YET RECRUITING

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Edmonton, Alberta, Canada

NOT YET RECRUITING

Rejuvenation Dermatology Clinic Edmonton South

Edmonton, Alberta, Canada

NOT YET RECRUITING

DermEdge Research

Mississauga, Ontario, Canada

NOT YET RECRUITING

FACET Dermatology

Toronto, Ontario, Canada

NOT YET RECRUITING

North York Research Inc.

Toronto, Ontario, Canada

NOT YET RECRUITING

Centre de Recherche Saint-Louis (Sherbrooke)

Sherbrooke, Quebec, Canada

RECRUITING

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

NOT YET RECRUITING

CCR Ostrava s.r.o.

Ostrava, Czechia

NOT YET RECRUITING

Pratia Pardubice a.s.

Pardubice, Czechia

NOT YET RECRUITING

Clintrial s.r.o.

Prague, Czechia

NOT YET RECRUITING

Fakultni Nemocnice Kralovske Vinohrady

Prague, Czechia

NOT YET RECRUITING

Praglandia s.r.o.

Prague, Czechia

NOT YET RECRUITING

Pratia Prague

Prague, Czechia

NOT YET RECRUITING

Fachklinik Bad Bentheim

Bad Bentheim, Germany

NOT YET RECRUITING

University Hospital Dresden

Dresden, Germany

NOT YET RECRUITING

Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie

Frankfurt, Germany

NOT YET RECRUITING

Dermatologikum Hamburg GmbH

Hamburg, Germany

NOT YET RECRUITING

University of Luebeck

Lübeck, Germany

NOT YET RECRUITING

University Hospital of Muenster

Münster, Germany

NOT YET RECRUITING

Hautarztpraxis Dr. Hoffmann

Witten, Germany

NOT YET RECRUITING

Trial Pharma Kft.

Békéscsaba, Hungary

NOT YET RECRUITING

Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University

Budapest, Hungary

NOT YET RECRUITING

Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

Debrecen, Hungary

NOT YET RECRUITING

Pecsi Tudomanyegyetem

Pécs, Hungary

NOT YET RECRUITING

Komplex Labor Kft

Szeged, Hungary

NOT YET RECRUITING

University of Szeged

Szeged, Hungary

NOT YET RECRUITING

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

NOT YET RECRUITING

OptiTrial

Chojnice, Poland

NOT YET RECRUITING

Dermedea Clinic

Gdansk, Poland

NOT YET RECRUITING

CM Pratia Katowice

Katowice, Poland

NOT YET RECRUITING

Provita Sp. z o. o.

Katowice, Poland

NOT YET RECRUITING

Klinika Zdybski - Dermedic (Kielce)

Kielce, Poland

NOT YET RECRUITING

Clinical Best Solution Sp. z o.o.

Lublin, Poland

NOT YET RECRUITING

NZOZ Hipokrates

Piotrkow Trybunalski, Poland

NOT YET RECRUITING

Twoja Przychodnia Poznanskie Centrum Medyczne Sp.

Poznan, Poland

NOT YET RECRUITING

Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski

Szczecin, Poland

NOT YET RECRUITING

Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.

Szczecin, Poland

NOT YET RECRUITING

Klinika Ambroziak Dermatologia

Warsaw, Poland

NOT YET RECRUITING

Medicus Clinic

Wroclaw, Poland

NOT YET RECRUITING

Softskin Medical Center Dr Elzbieta Wojtowicz-Prus

Wroclaw, Poland

NOT YET RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, Spain

NOT YET RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

La Paz, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Spain

NOT YET RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

NOT YET RECRUITING

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: May 15, 2026
• First Posted: May 20, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

BU (5); ES (5); DE (7); CZ (6); CA (9); HU (6); US (33); PL (14)