Galvokimig
BiologicalDrug: Galvokimig Pharmaceutical form: Solution for injection
Other names: UCB9741
NCT Number: NCT07277660
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Atd002 41004, Lovech, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: Galvokimig Pharmaceutical form: Solution for injection
Other names: UCB9741
Drug: Placebo Pharmaceutical form: Solution for injection
Time frame: 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
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: Baseline and 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: Up to Week 58
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
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:
Contact information is provided by the study sponsor or research team.
UCB Biopharma SRL
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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