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NCT07599813PHASE2Recruiting

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

Apollo Therapeutics Ltd

Start Date

5/28/2026

Completion Date

4/30/2028

Summary

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

Detailed Description

This study contains two parts: Part 1 and Part 2. Part 1 (24-Week Placebo-controlled Period): Eligible patients will be randomized in a 1:1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2, camoteskimab dose 3 or placebo. Part 2 (Extension Period): In part 2, all participants will receive camoteskimab. This study will enroll both treatment-naive participants and those with an inadequate response to previous biologic therapy.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: 1. Age 18-65 inclusive, at the time of signing the informed consent. 2. Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria. 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 Screening and Baseline. 2. AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline. 3. EASI score of ≥ 16 at Screening and at Baseline. 4. 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. 4. 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. 5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. Participant provides signed informed consent Exclusion Criteria: 1. 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. 2. Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline. 3. 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. 4. Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator. 5. 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. 6. 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. 7. 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. 8. Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit. 9. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test. 10. 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 (+). 11. 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. 12. Evidence of active or latent tuberculosis. 13. Receipt of live or attenuated live vaccine within 6 weeks prior to screening. 14. Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study. 15. Participant is known to have immune deficiency or is immunocompromised 16. 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 cell or squamous cell carcinoma of the skin. * Carcinoma in situ of the cervix. 17. Has had previous exposure to anti-IL-18 therapy. 18. Known allergy/sensitivity to any component of IMP. 19. History of use of any of these medications as follows: 1. Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline. 2. Systemic JAKi within 4 weeks prior to Baseline. 3. Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths. 4. Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. 5. Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening. 6. Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening. 7. UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study. 8. PUVA treatment within 4 weeks prior to Baseline 9. Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline 10. Topical products containing urea within 1 week prior to Baseline 11. Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline 12. Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline. 20. Female participant who is pregnant or breastfeeding or trying to conceive. 21. Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.

Interventions

DRUG

Camoteskimab

DRUG

Placebo

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Conditions

Atopic DermatitisAtopicDermatitisDermatitis, AtopicDermatologic DiseaseEczemaEczema Atopic DermatitisEczema, Atopic

Locations

AllerVie Clinical Research

Birmingham, Alabama 35209

United States

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama 35244

United States

Saguaro Dermatology Associates

Phoenix, Arizona 85018

United States

Dermatology Trial Associates, Inc

Bryant, Arkansas 72022

United States

Marvel Research, LLC

Huntington Beach, California 92648

United States

Metropolis Dermatology

Los Angeles, California 90025

United States

Dermatology Research Associates

Los Angeles, California 90048

United States

University of California Los Angeles

Los Angeles, California 90095

United States

Northridge Clinical Trials

Northridge, California 91325

United States

Integrative Skin Science and Research

Sacramento, California 95815

United States

Valiance Clinical Research - Tarzana

Tarzana, California 91356

United States

Paradigm Clinical Research Centers, LLC: Wheat Ridge

Wheat Ridge, Colorado 80033

United States

ABMED Clinical Research Corp.

Cape Coral, Florida 33904

United States

International Dermatology Research, INC

Hollywood, Florida 33021

United States

Quality Care Clinical Research

Miami, Florida 33101

United States

FXM Clinical Research Miami, LLC

Miami, Florida 33155

United States

Eminent Clinical Research and Associates

North Lauderdale, Florida 33068

United States

Ziaderm Research LLC

North Miami Beach, Florida 33162

United States

NMC Research LLC

Tampa, Florida 33614

United States

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

Savannah, Georgia 31406

United States

Ada West Research, LLC

Meridian, Idaho 83646

United States

Endeavor Health

Skokie, Illinois 60077

United States

DS Research of Southern Indiana,LLC

Clarksville, Indiana 47129

United States

Dawes Fretzin Clinical Research Group, LLC

Columbus, Indiana 47201

United States

Chesapeake Clinical Research, Inc

Pasadena, Maryland 21122

United States

Skin Cancer and Dermatology Institute

Reno, Nevada 89509

United States

Trail Horizon

Clifton, New Jersey 07013

United States

Sadick Research Group, LLC

New York, New York 10021

United States

Red River Research Partners, LLC

Fargo, North Dakota 58103

United States

ClinOhio Research Services

Columbus, Ohio 43213

United States

Best Skin Research, LLC

Camp Hill, Pennsylvania 17011

United States

UPMC Department of Dermatology

Pittsburgh, Pennsylvania 15213

United States

Progressive Clinical Research, PA

San Antonio, Texas 78213

United States

Medical Center Medconsult Burgas EOOD

Burgas,

Bulgaria

Medical Center Kazanlak EOOD

Kazanlak,

Bulgaria

Medical Center Medconsult Pleven-Lovech Branch

Lovech,

Bulgaria

Medical Center Medconsult Pleven OOD

Pleven,

Bulgaria

Medical Centre Pratia Clinic EOOD

Varna,

Bulgaria

Beacon Dermatology

Calgary, Alberta

Canada

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Calgary, Alberta

Canada

Laser Rejuvenation Clinics Edmonton D.T. Inc.

Edmonton, Alberta

Canada

Rejuvenation Dermatology Clinic Edmonton South

Edmonton, Alberta

Canada

DermEdge Research

Mississauga, Ontario

Canada

FACET Dermatology

Toronto, Ontario

Canada

North York Research Inc.

Toronto, Ontario

Canada

Centre de Recherche Saint-Louis (Sherbrooke)

Sherbrooke, Quebec

Canada

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan

Canada

CCR Ostrava s.r.o.

Ostrava,

Czechia

Pratia Pardubice a.s.

Pardubice,

Czechia

Clintrial s.r.o.

Prague,

Czechia

Fakultni Nemocnice Kralovske Vinohrady

Prague,

Czechia

Praglandia s.r.o.

Prague,

Czechia

Pratia Prague

Prague,

Czechia

Fachklinik Bad Bentheim

Bad Bentheim,

Germany

University Hospital Dresden

Dresden,

Germany

Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie

Frankfurt,

Germany

Dermatologikum Hamburg GmbH

Hamburg,

Germany

University of Luebeck

Lübeck,

Germany

University Hospital of Muenster

Münster,

Germany

Hautarztpraxis Dr. Hoffmann

Witten,

Germany

Trial Pharma Kft.

Békéscsaba,

Hungary

Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University

Budapest,

Hungary

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

Debrecen,

Hungary

Pecsi Tudomanyegyetem

Pécs,

Hungary

Komplex Labor Kft

Szeged,

Hungary

University of Szeged

Szeged,

Hungary

NZOZ Centrum Medyczne KERmed

Bydgoszcz,

Poland

OptiTrial

Chojnice,

Poland

Dermedea Clinic

Gdansk,

Poland

CM Pratia Katowice

Katowice,

Poland

Provita Sp. z o. o.

Katowice,

Poland

Klinika Zdybski - Dermedic (Kielce)

Kielce,

Poland

Clinical Best Solution Sp. z o.o.

Lublin,

Poland

NZOZ Hipokrates

Piotrkow Trybunalski,

Poland

Twoja Przychodnia Poznanskie Centrum Medyczne Sp.

Poznan,

Poland

Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski

Szczecin,

Poland

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

Szczecin,

Poland

Klinika Ambroziak Dermatologia

Warsaw,

Poland

Medicus Clinic

Wroclaw,

Poland

Softskin Medical Center Dr Elzbieta Wojtowicz-Prus

Wroclaw,

Poland

Hospital General Universitario Dr. Balmis

Alicante,

Spain

Hospital Universitari Germans Trias i Pujol

Badalona,

Spain

Hospital Universitario La Paz

La Paz,

Spain

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela,

Spain

Hospital Universitario Miguel Servet

Zaragoza,

Spain