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Набира участници Фаза 2 NCT07277660

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Atopic Dermatitis

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
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).
Кой може да участва
Inclusion Criteria: * 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: 1. validated Investigator Global Assessment (vIGA) score ≥3 at Screening and Baseline 2. Eczema Area and Severity Index (EASI) score ≥16 at both Screening and Baseline 3. Peak Pruritus Numerical Rating Scale (PP-NRS) score of ≥4 at both Screening and Baseline 4. ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline 5. 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 Exclusion Criteria: * 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
Интервенции
Galvokimig
BIOLOGICAL
Placebo
DRUG
Места на провеждане 50
България (5)
Atd002 41004
Lovech
Atd002 41001
Pleven
Atd002 41002
Sevlievo
Atd002 41005
Sofia
Atd002 41006
Sofia
Канада (2)
Atd002 51006
Hamilton
Atd002 51007
Toronto
Чехия (4)
Atd002 42002
Náchod
Atd002 42001
Prague
Atd002 42004
Prague
Atd002 42005
Prague
Германия (2)
Atd002 43004
Leipzig
Atd002 43007
Mahlow
Унгария (1)
Atd002 44003
Budapest
Япония (6)
Atd002 21001
Habikino
Atd002 21007
Nagoya
Atd002 21005
Sakai
Atd002 21008
Sapporo
Atd002 21004
Tachikawa-shi
Atd002 21006
Yokohama
Полша (9)
Atd002 45003
Krakow
Atd002 45007
Krakow
Atd002 45014
Krakow
Atd002 45005
Sosnowiec
Atd002 45009
Tarnów
Atd002 45002
Warsaw
Atd002 45004
Warsaw
Atd002 45006
Warsaw
Atd002 45008
Wroclaw
Великобритания (2)
Atd002 46004
London
Atd002 46003
Salford
САЩ (19)
Atd002 52013
Boca Raton , Florida
Atd002 52014
Bowling Green , Kentucky
Atd002 52017
Chicago , Illinois
Atd002 52007
Coral Gables , Florida
Atd002 52005
Dallas , Texas
Atd002 52016
Frisco , Texas
Atd002 52011
Frisco , Texas
Atd002 52003
Miami , Florida
Atd002 52012
New Albany , Indiana
Atd002 52021
Oceanside , California
Atd002 52010
Omaha , Nebraska
Atd002 52019
Philadelphia , Pennsylvania
Atd002 52008
Santa Monica , California
Atd002 52015
Savannah , Georgia
Atd002 52004
Sugar Land , Texas
Atd002 52020
The Bronx , New York
Atd002 52001
Troy , Michigan
Atd002 52009
Troy , Michigan
Atd002 52018
Wheaton , Illinois
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
29.12.2025
Крайна дата
06.03.2028
Регистрационен номер
NCT07277660
Източник
clinicaltrials.gov
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