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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Drug: Galvokimig Pharmaceutical form: Solution for injection
Drug: Placebo Pharmaceutical form: Solution for injection
Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16
The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. The severity of each clinical sign is scored as: 0=None to 3=Severe.
Time frame: Week 16
Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16
The vIGA score is using descriptors that best describe the overall appearance of the lesions at a given time point. Assessment: vIGA 0=clear to 4=severe
Time frame: Week 16
Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16
The PP-NRS is a single item patient-reported outcome (PRO) measure assessing the worst itch in the last 24 hours. It will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Time frame: Baseline and Week 16
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention until 8 weeks after final administration.
Time frame: Up to Week 58
Incidence of TE Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
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Atd002 52021
Oceanside, California, United States
Atd002 52008
Santa Monica, California, United States
Atd002 52013
Boca Raton, Florida, United States
Atd002 52007
Miami, Florida, United States
Atd002 52003
Miami, Florida, United States
Atd002 52015
Savannah, Georgia, United States
Atd002 52017
Chicago, Illinois, United States
Atd002 52018
Wheaton, Illinois, United States
Atd002 52012
New Albany, Indiana, United States
Atd002 52014
Bowling Green, Kentucky, United States
...and 58 more locations
Time frame: Up to Week 58