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

26. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

280

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bulgaria
      • Burgas, Bulgaria
        • Har ikke rekruttert ennå
        • Medical Center Medconsult Burgas EOOD
      • Kazanlak, Bulgaria
        • Har ikke rekruttert ennå
        • Medical Center Kazanlak EOOD
      • Lovech, Bulgaria
        • Har ikke rekruttert ennå
        • Medical Center Medconsult Pleven-Lovech Branch
      • Pleven, Bulgaria
        • Har ikke rekruttert ennå
        • Medical center Medconsult Pleven OOD
      • Varna, Bulgaria
        • Har ikke rekruttert ennå
        • Medical Centre Pratia Clinic EOOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Har ikke rekruttert ennå
        • Beacon Dermatology
      • Calgary, Alberta, Canada
        • Har ikke rekruttert ennå
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada
        • Rekruttering
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
        • Ta kontakt med:
      • Edmonton, Alberta, Canada
        • Rekruttering
        • Rejuvenation Dermatology Clinic Edmonton South
        • Ta kontakt med:
    • Ontario
      • Mississauga, Ontario, Canada
        • Rekruttering
        • DermEdge Research
        • Ta kontakt med:
      • Toronto, Ontario, Canada
        • Har ikke rekruttert ennå
        • FACET Dermatology
      • Toronto, Ontario, Canada
        • Rekruttering
        • North York Research Inc.
        • Ta kontakt med:
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Rekruttering
        • Centre de Recherche Saint-Louis (Sherbrooke)
        • Ta kontakt med:
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Rekruttering
        • Saskatoon Dermatology Centre
        • Ta kontakt med:
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • Rekruttering
        • Allervie Clinical Research
        • Ta kontakt med:
      • Birmingham, Alabama, Forente stater, 35244
        • Rekruttering
        • Cahaba Dermatology and Skin Health Center
        • Ta kontakt med:
    • Arizona
      • Phoenix, Arizona, Forente stater, 85018
    • Arkansas
      • Bryant, Arkansas, Forente stater, 72022
    • California
      • Huntington Beach, California, Forente stater, 92648
      • Los Angeles, California, Forente stater, 90095
        • Har ikke rekruttert ennå
        • University of California Los Angeles
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90025
      • Los Angeles, California, Forente stater, 90048
        • Rekruttering
        • Dermatology Research Associates
        • Ta kontakt med:
      • Northridge, California, Forente stater, 91325
      • Sacramento, California, Forente stater, 95815
      • Tarzana, California, Forente stater, 91356
    • Colorado
      • Wheat Ridge, Colorado, Forente stater, 80033
        • Rekruttering
        • Paradigm Clinical Research Centers, LLC: Wheat Ridge
        • Ta kontakt med:
    • Florida
      • Cape Coral, Florida, Forente stater, 33904
      • Hollywood, Florida, Forente stater, 33021
        • Rekruttering
        • Skin Care Research
        • Ta kontakt med:
      • Miami, Florida, Forente stater, 33101
      • Miami, Florida, Forente stater, 33155
        • Rekruttering
        • FXM Clinical Research Miami, LLC
        • Ta kontakt med:
      • North Lauderdale, Florida, Forente stater, 33068
        • Har ikke rekruttert ennå
        • Eminent Clinical Research and Associates
        • Ta kontakt med:
      • North Miami Beach, Florida, Forente stater, 33162
      • Tampa, Florida, Forente stater, 33614
        • Har ikke rekruttert ennå
        • NMC Research LLC
        • Ta kontakt med:
    • Georgia
      • Savannah, Georgia, Forente stater, 31406
        • Har ikke rekruttert ennå
        • Georgia Skin & Cancer Center
        • Ta kontakt med:
    • Idaho
      • Meridian, Idaho, Forente stater, 83646
    • Illinois
      • Skokie, Illinois, Forente stater, 60077
    • Indiana
      • Clarksville, Indiana, Forente stater, 47129
        • Rekruttering
        • DS Research of Southern Indiana,LLC
        • Ta kontakt med:
      • Indianapolis, Indiana, Forente stater, 46250
        • Rekruttering
        • Dawes Fretzin Clinical Research Group, LLC
        • Ta kontakt med:
    • Maryland
      • Pasadena, Maryland, Forente stater, 21122
        • Rekruttering
        • Chesapeake Clinical Research, Inc
        • Ta kontakt med:
    • Nevada
      • Reno, Nevada, Forente stater, 89509
        • Rekruttering
        • Skin Cancer and Dermatology Institute
        • Ta kontakt med:
    • New Jersey
      • Clifton, New Jersey, Forente stater, 07013
        • Har ikke rekruttert ennå
        • Trail Horizon
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10021
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58103
    • Ohio
      • Columbus, Ohio, Forente stater, 43213
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forente stater, 17011
        • Rekruttering
        • Best Skin Research, LLC
        • Ta kontakt med:
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Har ikke rekruttert ennå
        • UPMC Department of Dermatology
        • Ta kontakt med:
    • Texas
      • San Antonio, Texas, Forente stater, 78213
        • Rekruttering
        • Progressive Clinical Research, PA
        • Ta kontakt med:
  • Polen
      • Bydgoszcz, Polen
        • Har ikke rekruttert ennå
        • NZOZ Centrum Medyczne KERmed
      • Chojnice, Polen
        • Har ikke rekruttert ennå
        • OptiTrial
      • Gdansk, Polen
        • Har ikke rekruttert ennå
        • Dermedea Clinic
      • Katowice, Polen
        • Har ikke rekruttert ennå
        • CM Pratia Katowice
      • Katowice, Polen
        • Har ikke rekruttert ennå
        • Provita Sp. z o. o.
      • Kielce, Polen
        • Har ikke rekruttert ennå
        • Klinika Zdybski - Dermedic (Kielce)
      • Lublin, Polen
        • Har ikke rekruttert ennå
        • Clinical Best Solution Sp. z o.o.
      • Piotrkow Trybunalski, Polen
        • Har ikke rekruttert ennå
        • NZOZ Hipokrates
      • Poznan, Polen
        • Har ikke rekruttert ennå
        • Twoja Przychodnia Poznanskie Centrum Medyczne Sp.
      • Szczecin, Polen
        • Har ikke rekruttert ennå
        • Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski
      • Szczecin, Polen
        • Har ikke rekruttert ennå
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
      • Warsaw, Polen
        • Har ikke rekruttert ennå
        • Klinika Ambroziak Dermatologia
      • Wroclaw, Polen
        • Har ikke rekruttert ennå
        • Medicus Clinic
      • Wroclaw, Polen
        • Har ikke rekruttert ennå
        • Softskin Medical Center Dr Elzbieta Wojtowicz-Prus
  • Spania
      • Alicante, Spania
        • Har ikke rekruttert ennå
        • Hospital General Universitario Dr. Balmis
      • Badalona, Spania
        • Har ikke rekruttert ennå
        • Hospital Universitari Germans Trias i Pujol
      • La Paz, Spania
        • Har ikke rekruttert ennå
        • Hospital Universitario La Paz
      • Santiago de Compostela, Spania
        • Har ikke rekruttert ennå
        • Complejo Hospitalario Universitario de Santiago de Compostela
      • Zaragoza, Spania
        • Har ikke rekruttert ennå
        • Hospital Universitario Miguel Servet
  • Tsjekkia
      • Ostrava, Tsjekkia
        • Har ikke rekruttert ennå
        • CCR Ostrava s.r.o.
      • Pardubice, Tsjekkia
        • Har ikke rekruttert ennå
        • Pratia Pardubice a.s.
      • Prague, Tsjekkia
        • Har ikke rekruttert ennå
        • CLINTRIAL s.r.o.
      • Prague, Tsjekkia
        • Har ikke rekruttert ennå
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Tsjekkia
        • Har ikke rekruttert ennå
        • Praglandia s.r.o.
      • Prague, Tsjekkia
        • Har ikke rekruttert ennå
        • Pratia Prague
  • Tyskland
      • Bad Bentheim, Tyskland
        • Har ikke rekruttert ennå
        • Fachklinik Bad Bentheim
      • Dresden, Tyskland
        • Har ikke rekruttert ennå
        • University Hospital Dresden
      • Frankfurt, Tyskland
        • Har ikke rekruttert ennå
        • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
      • Hamburg, Tyskland
        • Har ikke rekruttert ennå
        • Dermatologikum Hamburg Gmbh
      • Lübeck, Tyskland
        • Har ikke rekruttert ennå
        • University of Luebeck
      • Münster, Tyskland
        • Har ikke rekruttert ennå
        • University Hospital of Muenster
      • Witten, Tyskland
        • Har ikke rekruttert ennå
        • Hautarztpraxis Dr. Hoffmann
  • Ungarn
      • Budapest, Ungarn
        • Har ikke rekruttert ennå
        • Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University
      • Békéscsaba, Ungarn
        • Har ikke rekruttert ennå
        • Trial Pharma Kft.
      • Debrecen, Ungarn
        • Har ikke rekruttert ennå
        • Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
      • Pécs, Ungarn
        • Har ikke rekruttert ennå
        • Pecsi Tudomanyegyetem
      • Szeged, Ungarn
        • Har ikke rekruttert ennå
        • University Of Szeged
      • Szeged, Ungarn
        • Har ikke rekruttert ennå
        • Komplex Labor Kft

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Dummy version of the study drug administered subcutaneously
Legemiddel: Placebo
Inaktivt stoff
Eksperimentell: Camoteskimab Dose Level 1
Camoteskimab administered subcutaneously
Legemiddel: Camoteskimab
Medikamentprodukt
Andre navn:
  • APL-9109
Eksperimentell: Camoteskimab Dose Level 2
Camoteskimab administered subcutaneously
Legemiddel: Camoteskimab
Medikamentprodukt
Andre navn:
  • APL-9109
Eksperimentell: Camoteskimab Dose Level 3
Camoteskimab administered subcutaneously
Legemiddel: Camoteskimab
Medikamentprodukt
Andre navn:
  • APL-9109

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Apollo Therapeutics Ltd

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mai 2026

Primær fullføring (Antatt)

31. oktober 2027

Studiet fullført (Antatt)

30. april 2028

Datoer for studieregistrering

Først innsendt

15. mai 2026

Først innsendt som oppfylte QC-kriteriene

15. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AP43CP04

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere