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

29. maj 2026 opdateret af: Apollo Therapeutics Ltd

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

280

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Burgas, Bulgarien
        • Ikke rekrutterer endnu
        • Medical Center Medconsult Burgas EOOD
      • Kazanlak, Bulgarien
        • Ikke rekrutterer endnu
        • Medical Center Kazanlak EOOD
      • Lovech, Bulgarien
        • Ikke rekrutterer endnu
        • Medical Center Medconsult Pleven-Lovech Branch
      • Pleven, Bulgarien
        • Ikke rekrutterer endnu
        • Medical Center Medconsult Pleven OOD
      • Varna, Bulgarien
        • Ikke rekrutterer endnu
        • Medical Centre Pratia Clinic EOOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Ikke rekrutterer endnu
        • Beacon Dermatology
      • Calgary, Alberta, Canada
        • Ikke rekrutterer endnu
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada
        • Ikke rekrutterer endnu
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada
        • Ikke rekrutterer endnu
        • Rejuvenation Dermatology Clinic Edmonton South
    • Ontario
      • Mississauga, Ontario, Canada
        • Ikke rekrutterer endnu
        • DermEdge Research
      • Toronto, Ontario, Canada
        • Ikke rekrutterer endnu
        • Facet Dermatology
      • Toronto, Ontario, Canada
        • Ikke rekrutterer endnu
        • North York Research Inc.
    • Quebec
      • Sherbrooke, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Rekruttering
        • Saskatoon Dermatology Centre
        • Kontakt:
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Ikke rekrutterer endnu
        • AllerVie Clinical Research
      • Birmingham, Alabama, Forenede Stater, 35244
        • Ikke rekrutterer endnu
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85018
        • Ikke rekrutterer endnu
        • Saguaro Dermatology Associates
    • Arkansas
      • Bryant, Arkansas, Forenede Stater, 72022
        • Ikke rekrutterer endnu
        • Dermatology Trial Associates, Inc
    • California
      • Huntington Beach, California, Forenede Stater, 92648
        • Ikke rekrutterer endnu
        • Marvel Research, LLC
      • Los Angeles, California, Forenede Stater, 90095
        • Ikke rekrutterer endnu
        • University of California Los Angeles
      • Los Angeles, California, Forenede Stater, 90025
        • Ikke rekrutterer endnu
        • Metropolis Dermatology
      • Los Angeles, California, Forenede Stater, 90048
        • Ikke rekrutterer endnu
        • Dermatology Research Associates
      • Northridge, California, Forenede Stater, 91325
      • Sacramento, California, Forenede Stater, 95815
      • Tarzana, California, Forenede Stater, 91356
        • Ikke rekrutterer endnu
        • Valiance Clinical Research - Tarzana
    • Colorado
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Ikke rekrutterer endnu
        • Paradigm Clinical Research Centers, LLC: Wheat Ridge
    • Florida
      • Cape Coral, Florida, Forenede Stater, 33904
        • Ikke rekrutterer endnu
        • ABMED Clinical Research Corp.
      • Hollywood, Florida, Forenede Stater, 33021
        • Ikke rekrutterer endnu
        • International Dermatology Research, INC
      • Miami, Florida, Forenede Stater, 33101
        • Ikke rekrutterer endnu
        • Quality Care Clinical Research
      • Miami, Florida, Forenede Stater, 33155
        • Ikke rekrutterer endnu
        • FXM Clinical Research Miami, LLC
      • North Lauderdale, Florida, Forenede Stater, 33068
        • Ikke rekrutterer endnu
        • Eminent Clinical Research and Associates
      • North Miami Beach, Florida, Forenede Stater, 33162
        • Ikke rekrutterer endnu
        • Ziaderm Research LLC
      • Tampa, Florida, Forenede Stater, 33614
        • Ikke rekrutterer endnu
        • NMC Research LLC
    • Georgia
      • Savannah, Georgia, Forenede Stater, 31406
        • Ikke rekrutterer endnu
        • Elligo - Georgia Skin & Cancer Clinic (Sidney P. Smith, MD, PC)
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Rekruttering
        • Ada West Research, LLC
        • Kontakt:
    • Illinois
      • Skokie, Illinois, Forenede Stater, 60077
        • Ikke rekrutterer endnu
        • Endeavor Health
    • Indiana
      • Clarksville, Indiana, Forenede Stater, 47129
        • Rekruttering
        • DS Research of Southern Indiana,LLC
        • Kontakt:
      • Columbus, Indiana, Forenede Stater, 47201
        • Ikke rekrutterer endnu
        • Dawes Fretzin Clinical Research Group, LLC
    • Maryland
      • Pasadena, Maryland, Forenede Stater, 21122
        • Ikke rekrutterer endnu
        • Chesapeake Clinical Research, Inc
    • Nevada
      • Reno, Nevada, Forenede Stater, 89509
        • Rekruttering
        • Skin Cancer and Dermatology Institute
        • Kontakt:
    • New Jersey
      • Clifton, New Jersey, Forenede Stater, 07013
        • Ikke rekrutterer endnu
        • Trail Horizon
    • New York
      • New York, New York, Forenede Stater, 10021
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • Ikke rekrutterer endnu
        • Red River Research Partners, LLC
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Rekruttering
        • ClinOhio Research Services
        • Kontakt:
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
        • Rekruttering
        • Best Skin Research, LLC
        • Kontakt:
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Ikke rekrutterer endnu
        • UPMC Department of Dermatology
    • Texas
      • San Antonio, Texas, Forenede Stater, 78213
        • Rekruttering
        • Progressive Clinical Research, PA
        • Kontakt:
  • Polen
      • Bydgoszcz, Polen
        • Ikke rekrutterer endnu
        • NZOZ Centrum Medyczne KERmed
      • Chojnice, Polen
        • Ikke rekrutterer endnu
        • OptiTrial
      • Gdansk, Polen
        • Ikke rekrutterer endnu
        • Dermedea Clinic
      • Katowice, Polen
        • Ikke rekrutterer endnu
        • CM Pratia Katowice
      • Katowice, Polen
        • Ikke rekrutterer endnu
        • Provita Sp. z o. o.
      • Kielce, Polen
        • Ikke rekrutterer endnu
        • Klinika Zdybski - Dermedic (Kielce)
      • Lublin, Polen
        • Ikke rekrutterer endnu
        • Clinical Best Solution Sp. z o.o.
      • Piotrkow Trybunalski, Polen
        • Ikke rekrutterer endnu
        • NZOZ Hipokrates
      • Poznan, Polen
        • Ikke rekrutterer endnu
        • Twoja Przychodnia Poznanskie Centrum Medyczne Sp.
      • Szczecin, Polen
        • Ikke rekrutterer endnu
        • Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski
      • Szczecin, Polen
        • Ikke rekrutterer endnu
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
      • Warsaw, Polen
        • Ikke rekrutterer endnu
        • Klinika Ambroziak Dermatologia
      • Wroclaw, Polen
        • Ikke rekrutterer endnu
        • Medicus Clinic
      • Wroclaw, Polen
        • Ikke rekrutterer endnu
        • Softskin Medical Center Dr Elzbieta Wojtowicz-Prus
  • Spanien
      • Alicante, Spanien
        • Ikke rekrutterer endnu
        • Hospital General Universitario Dr. Balmis
      • Badalona, Spanien
        • Ikke rekrutterer endnu
        • Hospital Universitari Germans Trias i Pujol
      • La Paz, Spanien
        • Ikke rekrutterer endnu
        • Hospital Universitario La Paz
      • Santiago de Compostela, Spanien
        • Ikke rekrutterer endnu
        • Complejo Hospitalario Universitario de Santiago de Compostela
      • Zaragoza, Spanien
        • Ikke rekrutterer endnu
        • Hospital Universitario Miguel Servet
  • Tjekkiet
      • Ostrava, Tjekkiet
        • Ikke rekrutterer endnu
        • CCR Ostrava s.r.o.
      • Pardubice, Tjekkiet
        • Ikke rekrutterer endnu
        • Pratia Pardubice a.s.
      • Prague, Tjekkiet
        • Ikke rekrutterer endnu
        • CLINTRIAL s.r.o.
      • Prague, Tjekkiet
        • Ikke rekrutterer endnu
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tjekkiet
        • Ikke rekrutterer endnu
        • Praglandia s.r.o.
      • Prague, Tjekkiet
        • Ikke rekrutterer endnu
        • Pratia Prague
  • Tyskland
      • Bad Bentheim, Tyskland
        • Ikke rekrutterer endnu
        • Fachklinik Bad Bentheim
      • Dresden, Tyskland
        • Ikke rekrutterer endnu
        • University Hospital Dresden
      • Frankfurt, Tyskland
        • Ikke rekrutterer endnu
        • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
      • Hamburg, Tyskland
        • Ikke rekrutterer endnu
        • Dermatologikum Hamburg GmbH
      • Lübeck, Tyskland
        • Ikke rekrutterer endnu
        • University of Luebeck
      • Münster, Tyskland
        • Ikke rekrutterer endnu
        • University Hospital of Muenster
      • Witten, Tyskland
        • Ikke rekrutterer endnu
        • Hautarztpraxis Dr. Hoffmann
  • Ungarn
      • Budapest, Ungarn
        • Ikke rekrutterer endnu
        • Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University
      • Békéscsaba, Ungarn
        • Ikke rekrutterer endnu
        • Trial Pharma Kft.
      • Debrecen, Ungarn
        • Ikke rekrutterer endnu
        • Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
      • Pécs, Ungarn
        • Ikke rekrutterer endnu
        • Pecsi Tudomanyegyetem
      • Szeged, Ungarn
        • Ikke rekrutterer endnu
        • University Of Szeged
      • Szeged, Ungarn
        • Ikke rekrutterer endnu
        • Komplex Labor Kft

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose 1
Camoteskimab administered subcutaneously
Medicin: Camoteskimab
Lægemiddelprodukt
Andre navne:
  • APL-9109
Eksperimentel: Dose 2
Camoteskimab administered subcutaneously
Medicin: Camoteskimab
Lægemiddelprodukt
Andre navne:
  • APL-9109
Eksperimentel: Dose 3
Camoteskimab administered subcutaneously
Medicin: Camoteskimab
Lægemiddelprodukt
Andre navne:
  • APL-9109
Placebo komparator: Placebo
Dummy version of the study drug administered subcutaneously
Medicin: Placebo
Inaktivt stof

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24
Tidsramme: From Baseline visit until Week 24 visit
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)
Tidsramme: 24 weeks
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
Tidsramme: 24 weeks
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
Tidsramme: 24 weeks
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Apollo Therapeutics Ltd

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

30. april 2028

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AP43CP04

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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