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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: UCB Biopharma SRL

NCT ID: NCT07277660

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Galvokimig (biological), Placebo (drug)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
Galvokimig — biological: Drug: Galvokimig Pharmaceutical form: Solution for injection · Placebo — drug: Drug: Placebo Pharmaceutical form: Solution for injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
165
Started
2025-12-29
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for atopic dermatitis
  • • Phase2 - 165 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with atopic dermatitis

Where?

  • • London - Atd002 46004
  • • Salford - Atd002 46003

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Atopic Dermatitis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Participant must be aged greater than or equal (≥)18 years at the time of signing the agreement to take part
  • ✓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

Who cannot take part

  • ✗Presence or family history (first degree) of inflammatory bowel disease (includes Crohn's disease and ulcerative...
  • ✗History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to...
  • ✗Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
  • ✗Previous treatment with galvokimig
  • ✗All systemic therapies (other than biologics), topical therapies and other treatments for AtD must be discontinued...
See the full criteria
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) 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

Where Is This Study? (2 UK sites)

Atd002 46004

London, United Kingdom

Atd002 46003

Salford, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09