Atopic Dermatitis
Conditions
Keywords
Atopic Dermatitis, Galvokimig,, UCB9741
Brief summary
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).
Interventions
BIOLOGICALGalvokimig
Drug: Galvokimig Pharmaceutical form: Solution for injection
DRUGPlacebo
Drug: Placebo Pharmaceutical form: Solution for injection
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16 | 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 | 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." |
| Incidence of Treatment-Emergent (TE) Adverse Events (AE) | 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. |
| Incidence of TE Serious Adverse Events (SAEs) | 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: * 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. |
Countries
Bulgaria, Canada, Czechia, Germany, Hungary, Japan, Poland, United Kingdom, United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 22733
Outcome results
None listed