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

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria
    • Not yet recruiting
    • Medical Center Medconsult Burgas EOOD
  • Kazanlak, Bulgaria
    • Not yet recruiting
    • Medical Center Kazanlak EOOD
  • Lovech, Bulgaria
    • Not yet recruiting
    • Medical Center Medconsult Pleven-Lovech Branch
  • Pleven, Bulgaria
    • Not yet recruiting
    • Medical center Medconsult Pleven OOD
  • Varna, Bulgaria
    • Not yet recruiting
    • Medical Centre Pratia Clinic EOOD
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Not yet recruiting
      • Beacon Dermatology
    • Calgary, Alberta, Canada
      • Not yet recruiting
      • Laser Rejuvenation Clinics Edmonton D.T. Inc.
    • Edmonton, Alberta, Canada
      • Not yet recruiting
      • Laser Rejuvenation Clinics Edmonton D.T. Inc.
    • Edmonton, Alberta, Canada
      • Not yet recruiting
      • Rejuvenation Dermatology Clinic Edmonton South
  • Ontario
    • Mississauga, Ontario, Canada
      • Not yet recruiting
      • DermEdge Research
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • FACET Dermatology
    • Toronto, Ontario, Canada
      • Not yet recruiting
      • North York Research Inc.
  • Quebec
    • Sherbrooke, Quebec, Canada
      • Recruiting
      • Centre de Recherche Saint-Louis (Sherbrooke)
      • Contact: Evelyn Chinchilla; Phone Number: 1-888-728-9142; Email: eachinchilla@recherchestlouis.com
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Not yet recruiting
      • Saskatoon Dermatology Centre
• Czechia
  • Ostrava, Czechia
    • Not yet recruiting
    • CCR Ostrava s.r.o.
  • Pardubice, Czechia
    • Not yet recruiting
    • Pratia Pardubice a.s.
  • Prague, 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
• Germany
  • Bad Bentheim, Germany
    • Not yet recruiting
    • Fachklinik Bad Bentheim
  • Dresden, Germany
    • Not yet recruiting
    • University Hospital Dresden
  • Frankfurt, Germany
    • Not yet recruiting
    • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
  • Hamburg, Germany
    • Not yet recruiting
    • Dermatologikum Hamburg GmbH
  • Lübeck, Germany
    • Not yet recruiting
    • University of Luebeck
  • Münster, Germany
    • Not yet recruiting
    • University Hospital of Muenster
  • Witten, Germany
    • Not yet recruiting
    • Hautarztpraxis Dr. Hoffmann
• Hungary
  • Budapest, Hungary
    • Not yet recruiting
    • Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University
  • Békéscsaba, Hungary
    • Not yet recruiting
    • Trial Pharma Kft.
  • Debrecen, Hungary
    • Not yet recruiting
    • Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
  • Pécs, Hungary
    • Not yet recruiting
    • Pecsi Tudomanyegyetem
  • Szeged, Hungary
    • Not yet recruiting
    • University of Szeged
  • Szeged, Hungary
    • Not yet recruiting
    • Komplex Labor Kft
• Poland
  • Bydgoszcz, Poland
    • Not yet recruiting
    • NZOZ Centrum Medyczne KERmed
  • Chojnice, Poland
    • Not yet recruiting
    • OptiTrial
  • Gdansk, Poland
    • Not yet recruiting
    • Dermedea Clinic
  • Katowice, Poland
    • Not yet recruiting
    • CM Pratia Katowice
  • Katowice, Poland
    • Not yet recruiting
    • Provita Sp. z o. o.
  • Kielce, Poland
    • Not yet recruiting
    • Klinika Zdybski - Dermedic (Kielce)
  • Lublin, Poland
    • Not yet recruiting
    • Clinical Best Solution Sp. z o.o.
  • Piotrkow Trybunalski, Poland
    • Not yet recruiting
    • NZOZ Hipokrates
  • Poznan, Poland
    • Not yet recruiting
    • Twoja Przychodnia Poznanskie Centrum Medyczne Sp.
  • Szczecin, 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.
  • Warsaw, Poland
    • Not yet recruiting
    • Klinika Ambroziak Dermatologia
  • Wroclaw, Poland
    • Not yet recruiting
    • Medicus Clinic
  • Wroclaw, Poland
    • Not yet recruiting
    • Softskin Medical Center Dr Elzbieta Wojtowicz-Prus
• Spain
  • Alicante, Spain
    • Not yet recruiting
    • Hospital General Universitario Dr. Balmis
  • Badalona, Spain
    • Not yet recruiting
    • Hospital Universitari Germans Trias I Pujol
  • La Paz, Spain
    • Not yet recruiting
    • Hospital Universitario La Paz
  • Santiago de Compostela, Spain
    • Not yet recruiting
    • Complejo Hospitalario Universitario de Santiago de Compostela
  • Zaragoza, Spain
    • Not yet recruiting
    • Hospital Universitario Miguel Servet
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Not yet recruiting
      • AllerVie Clinical Research
    • Birmingham, Alabama, United States, 35244
      • Not yet recruiting
      • Cahaba Dermatology and Skin Health Center
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Not yet recruiting
      • Saguaro Dermatology Associates
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Not yet recruiting
      • Dermatology Trial Associates, Inc
  • California
    • Huntington Beach, California, United States, 92648
      • Not yet recruiting
      • Marvel Research, LLC
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • University of California Los Angeles
    • Los Angeles, California, United States, 90025
      • Not yet recruiting
      • Metropolis Dermatology
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Dermatology Research Associates
    • Northridge, California, United States, 91324
      • Not yet recruiting
      • Clinical Trials Research Institute
    • Sacramento, California, United States, 95825
      • Not yet recruiting
      • Integrative Skin Science and Research
    • Tarzana, California, United States, 91356
      • Not yet recruiting
      • Valiance Clinical Research - Tarzana
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Not yet recruiting
      • Paradigm Clinical Research Centers, LLC: Wheat Ridge
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Not yet recruiting
      • ABMED Clinical Research Corp.
    • Hollywood, Florida, United States, 33021
      • Not yet recruiting
      • International Dermatology Research, INC
    • Miami, Florida, United States, 33101
      • Not yet recruiting
      • Quality Care Clinical Research
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • FXM Clinical Research Miami, LLC
    • North Lauderdale, Florida, United States, 33068
      • Not yet recruiting
      • Eminent Clinical Research and Associates
    • North Miami Beach, Florida, United States, 33162
      • Not yet recruiting
      • Ziaderm Research LLC
    • Tampa, Florida, United States, 33614
      • Not yet recruiting
      • NMC Research LLC
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Not yet recruiting
      • Elligo - Georgia Skin & Cancer Clinic (Sidney P. Smith, MD, PC)
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Not yet recruiting
      • Ada West Research, LLC
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Not yet recruiting
      • Endeavor Health
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Not yet recruiting
      • DS Research of Southern Indiana,LLC
    • Columbus, Indiana, United States, 47201
      • Not yet recruiting
      • Dawes Fretzin Clinical Research Group, LLC
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Not yet recruiting
      • Chesapeake Clinical Research, Inc
  • Nevada
    • Reno, Nevada, United States, 89502
      • Not yet recruiting
      • Mountain west derm blackhart PLLC Dba Skin Cancer and Dermatology Institute
  • New Jersey
    • Clifton, New Jersey, United States, 07013
      • Not yet recruiting
      • Trail Horizon
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Sadick Research Group, LLC
      • Contact: Sadick; Phone Number: 212-772-7242; Email: nssderm@sadickdermatology.com
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Not yet recruiting
      • Red River Research Partners, LLC
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Not yet recruiting
      • ClinOhio Research Services
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Recruiting
      • Best Skin Research, LLC
      • Contact: Steven Schleicher; Phone Number: 570-459-0029; Email: cutismd@aol.com
    • Pittsburgh, Pennsylvania, United States, 15213
      • Not yet recruiting
      • UPMC Department of Dermatology
  • Texas
    • San Antonio, Texas, United States, 78229
      • Not yet recruiting
      • Progressive Clinical Research, PA

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1; Camoteskimab	Drug: Camoteskimab; Drug Product; Other Names: APL-9109
Experimental: Dose 2; Camoteskimab	Drug: Camoteskimab; Drug Product; Other Names: APL-9109
Placebo Comparator: Placebo; Dummy version of the study drug	Drug: Placebo; Inactive substance
Experimental: Dose 3; Camoteskimab	Drug: Camoteskimab; Drug Product; Other Names: APL-9109

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)	To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).	24 weeks
Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline	To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via Validated Investigator's Global Assessment Scale, which provides a global clinical assessment of AD severity	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	To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Peak Pruritus Numerical Rating Scale, which assesses itch severity.	24 weeks

Collaborators and Investigators

• Sponsor: Apollo Therapeutics Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: May 15, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

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
• Other Study ID Numbers: AP43CP04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No