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

29 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Bulgaria
      • Burgas, Bulgaria
        • Non ancora reclutamento
        • Medical Center Medconsult Burgas EOOD
      • Kazanlak, Bulgaria
        • Non ancora reclutamento
        • Medical Center Kazanlak EOOD
      • Lovech, Bulgaria
        • Non ancora reclutamento
        • Medical Center Medconsult Pleven-Lovech Branch
      • Pleven, Bulgaria
        • Non ancora reclutamento
        • Medical Center Medconsult Pleven OOD
      • Varna, Bulgaria
        • Non ancora reclutamento
        • Medical Centre Pratia Clinic EOOD
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Non ancora reclutamento
        • Beacon Dermatology
      • Calgary, Alberta, Canada
        • Non ancora reclutamento
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada
        • Non ancora reclutamento
        • Laser Rejuvenation Clinics Edmonton D.T. Inc.
      • Edmonton, Alberta, Canada
        • Non ancora reclutamento
        • Rejuvenation Dermatology Clinic Edmonton South
    • Ontario
      • Mississauga, Ontario, Canada
        • Non ancora reclutamento
        • DermEdge Research
      • Toronto, Ontario, Canada
        • Non ancora reclutamento
        • Facet Dermatology
      • Toronto, Ontario, Canada
        • Non ancora reclutamento
        • North York Research Inc.
    • Quebec
      • Sherbrooke, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Reclutamento
        • Saskatoon Dermatology Centre
        • Contatto:
  • Cechia
      • Ostrava, Cechia
        • Non ancora reclutamento
        • CCR Ostrava s.r.o.
      • Pardubice, Cechia
        • Non ancora reclutamento
        • Pratia Pardubice a.s.
      • Prague, Cechia
        • Non ancora reclutamento
        • CLINTRIAL s.r.o.
      • Prague, Cechia
        • Non ancora reclutamento
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Cechia
        • Non ancora reclutamento
        • Praglandia s.r.o.
      • Prague, Cechia
        • Non ancora reclutamento
        • Pratia Prague
  • Germania
      • Bad Bentheim, Germania
        • Non ancora reclutamento
        • Fachklinik Bad Bentheim
      • Dresden, Germania
        • Non ancora reclutamento
        • University Hospital Dresden
      • Frankfurt, Germania
        • Non ancora reclutamento
        • Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie
      • Hamburg, Germania
        • Non ancora reclutamento
        • Dermatologikum Hamburg GmbH
      • Lübeck, Germania
        • Non ancora reclutamento
        • University of Luebeck
      • Münster, Germania
        • Non ancora reclutamento
        • University Hospital of Muenster
      • Witten, Germania
        • Non ancora reclutamento
        • Hautarztpraxis Dr. Hoffmann
  • Polonia
      • Bydgoszcz, Polonia
        • Non ancora reclutamento
        • NZOZ Centrum Medyczne KERmed
      • Chojnice, Polonia
        • Non ancora reclutamento
        • OptiTrial
      • Gdansk, Polonia
        • Non ancora reclutamento
        • Dermedea Clinic
      • Katowice, Polonia
        • Non ancora reclutamento
        • CM Pratia Katowice
      • Katowice, Polonia
        • Non ancora reclutamento
        • Provita Sp. z o. o.
      • Kielce, Polonia
        • Non ancora reclutamento
        • Klinika Zdybski - Dermedic (Kielce)
      • Lublin, Polonia
        • Non ancora reclutamento
        • Clinical Best Solution Sp. z o.o.
      • Piotrkow Trybunalski, Polonia
        • Non ancora reclutamento
        • NZOZ Hipokrates
      • Poznan, Polonia
        • Non ancora reclutamento
        • Twoja Przychodnia Poznanskie Centrum Medyczne Sp.
      • Szczecin, Polonia
        • Non ancora reclutamento
        • Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski
      • Szczecin, Polonia
        • Non ancora reclutamento
        • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
      • Warsaw, Polonia
        • Non ancora reclutamento
        • Klinika Ambroziak Dermatologia
      • Wroclaw, Polonia
        • Non ancora reclutamento
        • Medicus Clinic
      • Wroclaw, Polonia
        • Non ancora reclutamento
        • Softskin Medical Center Dr Elzbieta Wojtowicz-Prus
  • Spagna
      • Alicante, Spagna
        • Non ancora reclutamento
        • Hospital General Universitario Dr. Balmis
      • Badalona, Spagna
        • Non ancora reclutamento
        • Hospital Universitari Germans Trias i Pujol
      • La Paz, Spagna
        • Non ancora reclutamento
        • Hospital Universitario La Paz
      • Santiago de Compostela, Spagna
        • Non ancora reclutamento
        • Complejo Hospitalario Universitario de Santiago de Compostela
      • Zaragoza, Spagna
        • Non ancora reclutamento
        • Hospital Universitario Miguel Servet
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35209
        • Non ancora reclutamento
        • AllerVie Clinical Research
      • Birmingham, Alabama, Stati Uniti, 35244
        • Non ancora reclutamento
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85018
        • Non ancora reclutamento
        • Saguaro Dermatology Associates
    • Arkansas
      • Bryant, Arkansas, Stati Uniti, 72022
        • Non ancora reclutamento
        • Dermatology Trial Associates, Inc
    • California
      • Huntington Beach, California, Stati Uniti, 92648
        • Non ancora reclutamento
        • Marvel Research, LLC
      • Los Angeles, California, Stati Uniti, 90095
        • Non ancora reclutamento
        • University of California Los Angeles
      • Los Angeles, California, Stati Uniti, 90025
        • Non ancora reclutamento
        • Metropolis Dermatology
      • Los Angeles, California, Stati Uniti, 90048
        • Non ancora reclutamento
        • Dermatology Research Associates
      • Northridge, California, Stati Uniti, 91325
      • Sacramento, California, Stati Uniti, 95815
      • Tarzana, California, Stati Uniti, 91356
        • Non ancora reclutamento
        • Valiance Clinical Research - Tarzana
    • Colorado
      • Wheat Ridge, Colorado, Stati Uniti, 80033
        • Non ancora reclutamento
        • Paradigm Clinical Research Centers, LLC: Wheat Ridge
    • Florida
      • Cape Coral, Florida, Stati Uniti, 33904
        • Non ancora reclutamento
        • ABMED Clinical Research Corp.
      • Hollywood, Florida, Stati Uniti, 33021
        • Non ancora reclutamento
        • International Dermatology Research, INC
      • Miami, Florida, Stati Uniti, 33101
        • Non ancora reclutamento
        • Quality Care Clinical Research
      • Miami, Florida, Stati Uniti, 33155
        • Non ancora reclutamento
        • FXM Clinical Research Miami, LLC
      • North Lauderdale, Florida, Stati Uniti, 33068
        • Non ancora reclutamento
        • Eminent Clinical Research and Associates
      • North Miami Beach, Florida, Stati Uniti, 33162
        • Non ancora reclutamento
        • Ziaderm Research LLC
      • Tampa, Florida, Stati Uniti, 33614
        • Non ancora reclutamento
        • NMC Research LLC
    • Georgia
      • Savannah, Georgia, Stati Uniti, 31406
        • Non ancora reclutamento
        • Elligo - Georgia Skin & Cancer Clinic (Sidney P. Smith, MD, PC)
    • Idaho
      • Meridian, Idaho, Stati Uniti, 83646
        • Reclutamento
        • Ada West Research, LLC
        • Contatto:
    • Illinois
      • Skokie, Illinois, Stati Uniti, 60077
        • Non ancora reclutamento
        • Endeavor Health
    • Indiana
      • Clarksville, Indiana, Stati Uniti, 47129
        • Reclutamento
        • DS Research of Southern Indiana,LLC
        • Contatto:
      • Columbus, Indiana, Stati Uniti, 47201
        • Non ancora reclutamento
        • Dawes Fretzin Clinical Research Group, LLC
    • Maryland
      • Pasadena, Maryland, Stati Uniti, 21122
        • Non ancora reclutamento
        • Chesapeake Clinical Research, Inc
    • Nevada
      • Reno, Nevada, Stati Uniti, 89509
        • Reclutamento
        • Skin Cancer and Dermatology Institute
        • Contatto:
    • New Jersey
      • Clifton, New Jersey, Stati Uniti, 07013
        • Non ancora reclutamento
        • Trail Horizon
    • New York
      • New York, New York, Stati Uniti, 10021
    • North Dakota
      • Fargo, North Dakota, Stati Uniti, 58103
        • Non ancora reclutamento
        • Red River Research Partners, LLC
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43213
        • Reclutamento
        • ClinOhio Research Services
        • Contatto:
    • Pennsylvania
      • Camp Hill, Pennsylvania, Stati Uniti, 17011
        • Reclutamento
        • Best Skin Research, LLC
        • Contatto:
          • Steven Schleicher
          • Numero di telefono: 570-459-0029
          • Email: cutismd@aol.com
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Non ancora reclutamento
        • UPMC Department of Dermatology
    • Texas
      • San Antonio, Texas, Stati Uniti, 78213
        • Reclutamento
        • Progressive Clinical Research, PA
        • Contatto:
  • Ungheria
      • Budapest, Ungheria
        • Non ancora reclutamento
        • Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University
      • Békéscsaba, Ungheria
        • Non ancora reclutamento
        • Trial Pharma Kft.
      • Debrecen, Ungheria
        • Non ancora reclutamento
        • Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
      • Pécs, Ungheria
        • Non ancora reclutamento
        • Pecsi Tudomanyegyetem
      • Szeged, Ungheria
        • Non ancora reclutamento
        • University Of Szeged
      • Szeged, Ungheria
        • Non ancora reclutamento
        • Komplex Labor Kft

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dose 1
Camoteskimab administered subcutaneously
Droga: Camoteskimab
Prodotto farmaceutico
Altri nomi:
  • APL-9109
Sperimentale: Dose 2
Camoteskimab administered subcutaneously
Droga: Camoteskimab
Prodotto farmaceutico
Altri nomi:
  • APL-9109
Sperimentale: Dose 3
Camoteskimab administered subcutaneously
Droga: Camoteskimab
Prodotto farmaceutico
Altri nomi:
  • APL-9109
Comparatore placebo: Placebo
Dummy version of the study drug administered subcutaneously
Droga: Placebo
Sostanza inattiva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Apollo Therapeutics Ltd

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 maggio 2026

Completamento primario (Stimato)

31 ottobre 2027

Completamento dello studio (Stimato)

30 aprile 2028

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

20 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AP43CP04

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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