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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Camoteskimab
  Drug Product
• Препарат Placebo
  Inactive substance

Первичные конечные точки

• Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24 [Срок оценки: From Baseline visit until Week 24 visit]

Вторичные конечные точки (3)

• Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75) [Срок оценки: 24 weeks]
• Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline [Срок оценки: 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 [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Age 18-65 inclusive, at the time of signing the informed consent.
• Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
• Participants with moderate-to-severe AD defined by:

• 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.
• AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline.
• EASI score of ≥ 16 at Screening and at Baseline.
• 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.
• 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.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Participant provides signed informed consent

Критерии исключения

• 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.
• Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
• 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.
• Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
• 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.
• 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.
• 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.
• Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
• Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
• 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 (+).
• 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.
• Evidence of active or latent tuberculosis.
• Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
• Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
• Participant is known to have immune deficiency or is immunocompromised
• 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.
• Has had previous exposure to anti-IL-18 therapy.
• Known allergy/sensitivity to any component of IMP.
• History of use of any of these medications as follows:

• Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline.
• Systemic JAKi within 4 weeks prior to Baseline.
• 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.
• 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.
• 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.
• Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening.
• UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study.
• PUVA treatment within 4 weeks prior to Baseline
• Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline
• Topical products containing urea within 1 week prior to Baseline
• Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline
• Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline.
• Female participant who is pregnant or breastfeeding or trying to conceive.
• Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 33 центра

• AllerVie Clinical Research — Birmingham
• Cahaba Dermatology and Skin Health Center — Birmingham
• Saguaro Dermatology Associates — Phoenix
• Dermatology Trial Associates, Inc — Bryant
• Marvel Research, LLC — Huntington Beach
• Metropolis Dermatology — Los Angeles
• Dermatology Research Associates — Los Angeles
• University of California Los Angeles — Los Angeles
• … и ещё 25 центров

Польша · 14 центров

• NZOZ Centrum Medyczne KERmed — Bydgoszcz
• OptiTrial — Chojnice
• Dermedea Clinic — Gdansk
• CM Pratia Katowice — Katowice
• Provita Sp. z o. o. — Katowice
• Klinika Zdybski - Dermedic (Kielce) — Kielce
• Clinical Best Solution Sp. z o.o. — Lublin
• NZOZ Hipokrates — Piotrkow Trybunalski
• … и ещё 6 центров

Канада · 9 центров

• Beacon Dermatology — Calgary
• Laser Rejuvenation Clinics Edmonton D.T. Inc. — Calgary
• Laser Rejuvenation Clinics Edmonton D.T. Inc. — Edmonton
• Rejuvenation Dermatology Clinic Edmonton South — Edmonton
• DermEdge Research — Mississauga
• FACET Dermatology — Toronto
• North York Research Inc. — Toronto
• Centre de Recherche Saint-Louis (Sherbrooke) — Sherbrooke
• … и ещё 1 центр

Германия · 7 центров

• Fachklinik Bad Bentheim — Bad Bentheim
• University Hospital Dresden — Dresden
• Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie — Frankfurt
• Dermatologikum Hamburg GmbH — Hamburg
• University of Luebeck — Lübeck
• University Hospital of Muenster — Münster
• Hautarztpraxis Dr. Hoffmann — Witten

Чехия · 6 центров

• CCR Ostrava s.r.o. — Ostrava
• Pratia Pardubice a.s. — Pardubice
• Clintrial s.r.o. — Prague
• Fakultni Nemocnice Kralovske Vinohrady — Prague
• Praglandia s.r.o. — Prague
• Pratia Prague — Prague

Венгрия · 6 центров

• Trial Pharma Kft. — Békéscsaba
• Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University — Budapest
• Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Med — Debrecen
• Pecsi Tudomanyegyetem — Pécs
• Komplex Labor Kft — Szeged
• University of Szeged — Szeged

Болгария · 5 центров

• Medical Center Medconsult Burgas EOOD — Burgas
• Medical Center Kazanlak EOOD — Kazanlak
• Medical Center Medconsult Pleven-Lovech Branch — Lovech
• Medical Center Medconsult Pleven OOD — Pleven
• Medical Centre Pratia Clinic EOOD — Varna

Испания · 5 центров

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07599813 · AP43CP04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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