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).
Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent
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
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
Parallel
Galvokimig
Biological/VaccineDrug: Galvokimig Pharmaceutical form: Solution for injection
Placebo
DrugDrug: 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.
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
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."
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.
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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