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

Last updated: January 2, 2025
Sponsor: Apollo Therapeutics Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Dermatitis, Atopic

Molluscum Contagiosum (Pediatric)

Treatment

Camoteskimab

Placebo

Clinical Study ID

NCT06436183
AP43CP03
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must be 18-75 years of age inclusive, at the time of signing theinformed consent.

  2. Chronic AD for at least 1 year.

  3. Participants with moderate to severe AD defined by:

  4. Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, inwhich three is moderate and four is severe) at Baseline.

  5. AD involvement of ≥ 10% body surface area (BSA) at Baseline.

  6. EASI score of ≥ 12 at Baseline.

  7. Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.

  8. Participants who are candidates for systemic therapy, defined as inadequate responseto treatment with topical medications, or for whom topical treatments are otherwisemedically inadvisable.

  9. Contraceptive use should be consistent with local regulations regarding the methodsof contraception for those participating in clinical studies. Female participants:

  • Sexually active females of childbearing potential must agree to use two formsof accepted methods of highly effective forms of contraception during thecourse 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 killsperm); or

  • A vasectomized partner*. Male participants:

  • Sexually active male participants and males and who are partners of females ofchildbearing potential agree to use two forms of contraception as above and tonot donate sperm or try to conceive during the treatment period and for atleast 3 months after the last dose of study drug.

  1. Participant provides signed informed consent.

Exclusion

Exclusion Criteria:

  1. 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:

  2. Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.

  3. Systemic JAKi within 4 weeks prior to Baseline.

  4. TCS, TCI, topical phosphodiesterase-4 (PDE4) inhibitors, and topical JAKiwithin 7 days prior to enrollment (at Baseline) or more than five half-liveswhichever is longer.

  5. Participant has a current diagnosis of other active skin disease (e.g., psoriasis orlupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affectthe evaluation of AD or would interfere with the study assessments.

  6. Participant has a severe comorbidity that may require systemic steroids therapy orother interventions or requires active frequent monitoring (e.g., unstable chronicasthma).

  7. Any clinically significant abnormalities in rhythm, conduction or morphology of theresting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with theinterpretation of QTc interval changes.

  8. Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, orkeratitis diagnosed within the last 60 days prior to the screening visit, requiringchronic ocular corticosteroid treatment.

  9. Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or anyother non-AD disease as judged by the Investigator. Participants with seasonal orallergic rhinitis, asthma or any other non-AD disease requiring use of intranasal orinhaled corticosteroid that is stable and well-controlled are not excluded.

  10. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIVAb) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBsAg) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Activehepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence ofactive or latent TB

  11. Diagnosed with a malignancy within 5 years of enrollment (suspected malignancyshould 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.

  1. Has had previous exposure to anti-IL-18 therapy.

  2. Treatment with any investigational agent, or any investigational device orprocedure, within 28 days (or 5 half- lives, whichever is greater) of screening.

  3. Has any of the following laboratory findings

  4. Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2.

  5. Hemoglobin ≤8 g/dL.

  6. Neutrophils ≤1,500/μL.

  7. Platelets ≤75,000/μL.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Camoteskimab
Phase: 2
Study Start date:
May 01, 2024
Estimated Completion Date:
June 30, 2025

Study Description

This study contains two parts: Parts 1 and Part 2.

Part 1 (Blinded Period):

Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo.

Part 2 (Extension Period):

In part 2, all participants will receive camoteskimab.

Connect with a study center

  • Rejuvenation Dermatology Clinic Edmonton South

    Edmonton, Alberta T6W 0J5
    Canada

    Site Not Available

  • Youthful Image

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

  • Kingsway Clinical Research

    Etobicoke, Ontario M8X 1Y9
    Canada

    Active - Recruiting

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario K1H 1E4
    Canada

    Site Not Available

  • Clinique Medicale Saint-Louis

    Québec, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Clinique Dermatologique de Sherbrooke

    Sherbrooke, Quebec J1G 1X9
    Canada

    Active - Recruiting

  • Medical Dermatology Specialists, PC/US Dermatology Partners

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Active - Recruiting

  • First OC Dermatology Research, Inc.

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Active - Recruiting

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Keck School of Medicine of USC

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Los Angeles Dermatology

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Amicis Research Center (Northridge)

    Northridge, California 91324
    United States

    Active - Recruiting

  • Cura Clinical Research

    Oxnard, California 93030
    United States

    Active - Recruiting

  • VASDHS - Veterans Affairs San Diego Medical Center

    San Diego, California 92161
    United States

    Site Not Available

  • Clinical Sciences Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Renaissance Research and Medical Group

    Cape Coral, Florida 33991
    United States

    Active - Recruiting

  • Floridian Research Institute, Llc

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • D&H National Research Centers, Inc.

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Avita Clinical Research - Dermatology

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • GCP Clinical Research

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Owensboro Dermatology Associates

    Owensboro, Kentucky 42303
    United States

    Active - Recruiting

  • Revival Research Institute

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Somerset Skin Centre

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Michigan Dermatology Institute

    Waterford, Michigan 28329
    United States

    Active - Recruiting

  • Advanced Dermatology and Skin Cancer Center - Saint Joseph

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Skin Specialists PC

    Omaha, Nebraska 68144
    United States

    Active - Recruiting

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • ObjectiveHealth-The Skin Surgery Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73071
    United States

    Active - Recruiting

  • Unity Clinical Research - Dermatology

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • Paddington Testing Co. Inc

    Philadelphia, Pennsylvania 19103
    United States

    Active - Recruiting

  • Rodgers Dermatology

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Active - Recruiting

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