A Phase 2 interventional study of Galvokimig and Placebo in Atopic Dermatitis, sponsored by UCB Biopharma SRL. Active, not recruiting at 59 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by UCB Biopharma SRL · Phase 2, Interventional, and Treatment
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).
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 165 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Biological: Galvokimig
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Biological: Galvokimig
Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
Biological: Galvokimig
Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
Biological: Galvokimig · Drug: Placebo
Drug: Galvokimig Pharmaceutical form: Solution for injection
Also known as: UCB9741
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.
Time frame: Up to Week 58
Plan to share: Yes — Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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UCB Biopharma SRL