Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07277660

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atd002 41004, Lovech, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • ≥10% body surface area (BSA) of AtD involvement at both Screening and Baseline
  • 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) exclusion criteria
  • Previous treatment with galvokimig
  • Participant has relevant safety events to one or more interleukin (IL)-13 biologic response modifiers (ie, dupilumab, tralokinumab and lebrikizumab) that resulted in discontinuation and change of treatment
  • All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued at least 4 weeks prior to Baseline
  • Treatment with biologic agents must discontinued at least 3 months prior to baseline

Treatment and study plan

Galvokimig

Biological

Drug: Galvokimig Pharmaceutical form: Solution for injection

Other names: UCB9741

Placebo

Drug

Drug: Placebo Pharmaceutical form: Solution for injection

Primary outcomes

  1. Percentage of participants with Eczema Area and Severity Index (EASI)75 response at Week 16

    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.

Secondary outcomes

  1. Percentage of Participants with validated Investigator Global Assessment (vIGA) response at Week 16

    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

  2. Change from Baseline in weekly averaged Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16

    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."

  3. Incidence of Treatment-Emergent (TE) Adverse Events (AE)

    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.

  4. Incidence of TE Serious Adverse Events (SAEs)

    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:

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

UCB Cares

CONTACT

[email protected]

+18445992273

UCB Cares

CONTACT

[email protected]

0018445992273

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 11, 2025
Registry last updated
Jul 17, 2026

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.

Published trials that share one or more normalized conditions with this study.