A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Moderate to Severe Atopic Dermatitis

Обзор

The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).

Вмешательства

• Биопрепарат Galvokimig
  Drug: Galvokimig Pharmaceutical form: Solution for injection
• Препарат Placebo
  Drug: Placebo Pharmaceutical form: Solution for injection

Первичные конечные точки

• Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16 [Срок оценки: Week 16]

Вторичные конечные точки (4)

• Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16 [Срок оценки: Week 16]
• Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16 [Срок оценки: Baseline and Week 16]
• Incidence of Treatment-Emergent (TE) Adverse Events (AE) [Срок оценки: Up to Week 58]
• Incidence of TE Serious Adverse Events (SAEs) [Срок оценки: Up to Week 58]

Критерии участия

Критерии включения

• Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
• Participant has chronic atopic dermatitis (AtD) (according to American Academy of Dermatology Consensus Criteria) that has been present for at least ≥1 year prior to initiating the study (ie, signing of the informed consent form \[ICF\]) and with:

• validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline
• Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline
• Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline
• ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
• Documented recent history (within 6 months prior to Screening) of inadequate response to treatment with topical medications, or study participants for whom topical treatments are otherwise medically inadvisable (eg, due to important side effects or safety risks) and who are candidates for systemic therapy

Критерии исключения

• Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study
• Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, active allergic or irritant contact dermatitis
• Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
• History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline (including herpes zoster) as judged by the investigator
• Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
• Previous treatment with galvokimig
• Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment
• All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
• Treatment with biologic agents must discontinued at least 3 months prior to baseline

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Atd002 52021 — Oceanside
• Atd002 52008 — Santa Monica
• Atd002 52013 — Boca Raton
• Atd002 52007 — Miami
• Atd002 52003 — Miami
• Atd002 52015 — Savannah
• Atd002 52017 — Chicago
• Atd002 52018 — Wheaton
• … и ещё 12 центров

Польша · 13 центров

• Atd002 45011 — Chorzów
• Atd002 45001 — Katowice
• Atd002 45003 — Krakow
• Atd002 45007 — Krakow
• Atd002 45010 — Krakow
• Atd002 45014 — Krakow
• Atd002 45004 — Lodz
• Atd002 45013 — Lodz
• … и ещё 5 центров

Болгария · 7 центров

• Atd002 41004 — Lovech
• Atd002 41001 — Pleven
• Atd002 41007 — Plovdiv
• Atd002 41002 — Sevlievo
• Atd002 41003 — Sofia
• Atd002 41005 — Sofia
• Atd002 41006 — Sofia

Япония · 7 центров

• Atd002 21001 — Habikino
• Atd002 21002 — Nagasaki
• Atd002 21007 — Nagoya
• Atd002 21005 — Sakai
• Atd002 21008 — Sapporo
• Atd002 21004 — Tachikawa-shi
• Atd002 21006 — Yokohama

Германия · 6 центров

• Atd002 43001 — Bad Bentheim
• Atd002 43005 — Dresden
• Atd002 43002 — Frankfurt
• Atd002 43004 — Leipzig
• Atd002 43003 — Lübeck
• Atd002 43007 — Mahlow

Чехия · 5 центров

• Atd002 42002 — Náchod
• Atd002 42001 — Prague
• Atd002 42003 — Prague
• Atd002 42004 — Prague
• Atd002 42005 — Prague

Канада · 4 центра

• Atd002 51002 — Edmonton
• Atd002 51006 — Hamilton
• Atd002 51007 — Toronto
• Atd002 51003 — Vancouver

Великобритания · 4 центра

• Atd002 46004 — London
• Atd002 46007 — London
• Atd002 46003 — Salford
• Atd002 46006 — Sheffield

Венгрия · 2 центра

• Atd002 44003 — Budapest
• Atd002 44001 — Debrecen

Идентификаторы

NCT: NCT07277660 · ATD002 · 2025-522578-35 · U1111-1326-9886

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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