Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating Galvokimig in Adults With Moderate to Severe Atopic Dermatitis
Led by UCB Biopharma SRL · Updated on 2026-06-05
160
Participants Needed
64
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how different doses of galvokimig compare with a placebo in adults with moderate-to-severe atopic dermatitis, a chronic skin condition. This Phase 2 study aims to understand the relationship between the dose given and its effects on the condition, focusing on safety, how the drug moves through and acts in the body, and its overall impact on the disease. Participants will be randomly assigned to receive one of three different doses of galvokimig or a placebo during the initial treatment period. After 16 weeks, participants will either continue on the same dose or switch to a modified dose based on the study plan. Galvokimig and placebo are given as injections, and the study is designed to be double-blind, meaning neither participants nor researchers know who receives which treatment during the initial phase. During the study, participants will be regularly evaluated for changes in their eczema severity, itch intensity, and overall response to treatment using specific scales like the Eczema Area and Severity Index (EASI) and Peak Pruritus Numerical Rating Scale (PP-NRS). Safety is closely monitored through reports of adverse events up to week 58. The study lasts at least 16 weeks with ongoing assessments to track treatment effects and safety over time.
CONDITIONS
Brief Title
A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be aged 18 years or older at the time of signing informed consent
- Diagnosis of chronic atopic dermatitis for at least 1 year according to American Academy of Dermatology criteria
- Validated Investigator Global Assessment (vIGA) score of 3 or higher at Screening and Baseline
- Eczema Area and Severity Index (EASI) score of 16 or higher at Screening and Baseline
- Peak Pruritus Numerical Rating Scale (PP-NRS) score of 4 or higher at Screening and Baseline
- Atopic dermatitis involvement of at least 10% body surface area at Screening and Baseline
- Documented history within 6 months prior to Screening of inadequate response to topical treatments or topical treatments medically inadvisable, and candidate for systemic therapy
You will not qualify if you...
- Any medical or psychiatric condition, lab test result, physical exam finding, or ECG signal that poses risk or interferes with study participation
- Active skin conditions that could confuse atopic dermatitis diagnosis or assessment, including scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis, psoriasis, or active allergic or irritant contact dermatitis
- Personal or first-degree family history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- History of chronic, recurrent, or serious infections within 6 months prior to Baseline
- Meeting tuberculosis exclusion criteria
- Prior treatment with galvokimig
- Safety issues causing discontinuation of interleukin-13 biologic treatments like dupilumab, tralokinumab, or lebrikizumab
- Use of systemic therapies (other than biologics), topical therapies, or other atopic dermatitis treatments within 4 weeks prior to Baseline
- Use of biologic agents within 3 months prior to Baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 58 weeks
Participants receive predefined doses of Galvokimig or placebo during the initial intervention period and continue on the same or a modified dose after week 16.
Regular visits during treatment period
Trial Site Locations
Total: 64 locations
1
Atd002 52021
Oceanside, California, United States, 92056
Actively Recruiting
2
Atd002 52008
Santa Monica, California, United States, 90404
Actively Recruiting
3
Atd002 52013
Boca Raton, Florida, United States, 33486
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4
Atd002 52007
Coral Gables, Florida, United States, 33134
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5
Atd002 52003
Miami, Florida, United States, 33133
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6
Atd002 52015
Savannah, Georgia, United States, 31419
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7
Atd002 52017
Chicago, Illinois, United States, 60611
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8
Atd002 52018
Wheaton, Illinois, United States, 60189
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9
Atd002 52012
New Albany, Indiana, United States, 47150
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10
Atd002 52014
Bowling Green, Kentucky, United States, 42104
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11
Atd002 52001
Troy, Michigan, United States, 48084
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12
Atd002 52009
Troy, Michigan, United States, 48084
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13
Atd002 52010
Omaha, Nebraska, United States, 68144
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14
Atd002 52022
New York, New York, United States, 10029-6574
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15
Atd002 52020
The Bronx, New York, United States, 10455
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16
Atd002 52019
Philadelphia, Pennsylvania, United States, 19114
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17
Atd002 52005
Dallas, Texas, United States, 75230
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18
Atd002 52016
Frisco, Texas, United States, 75033
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19
Atd002 52011
Frisco, Texas, United States, 75034
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20
Atd002 52004
Sugar Land, Texas, United States, 77479
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21
Atd002 41004
Lovech, Bulgaria
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22
Atd002 41001
Pleven, Bulgaria
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23
Atd002 41007
Plovdiv, Bulgaria
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24
Atd002 41002
Sevlievo, Bulgaria
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25
Atd002 41005
Sofia, Bulgaria
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26
Atd002 41006
Sofia, Bulgaria
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27
Atd002 51006
Hamilton, Canada
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28
Atd002 51007
Toronto, Canada
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29
Atd002 42002
Náchod, Czechia
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30
Atd002 42001
Prague, Czechia
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31
Atd002 42004
Prague, Czechia
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32
Atd002 42005
Prague, Czechia
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33
Atd002 43001
Bad Bentheim, Germany
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34
Atd002 43005
Dresden, Germany
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35
Atd002 43002
Frankfurt, Germany
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36
Atd002 43004
Leipzig, Germany
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37
Atd002 43003
Lübeck, Germany
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38
Atd002 43007
Mahlow, Germany
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39
Atd002 44003
Budapest, Hungary
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40
Atd002 44001
Debrecen, Hungary
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41
Atd002 21001
Habikino, Japan
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42
Atd002 21002
Nagasaki, Japan
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43
Atd002 21007
Nagoya, Japan
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44
Atd002 21005
Sakai, Japan
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45
Atd002 21008
Sapporo, Japan
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46
Atd002 21004
Tachikawa-shi, Japan
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47
Atd002 21006
Yokohama, Japan
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48
Atd002 45011
Chorzów, Poland
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49
Atd002 45001
Katowice, Poland
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50
Atd002 45003
Krakow, Poland
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51
Atd002 45007
Krakow, Poland
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52
Atd002 45010
Krakow, Poland
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53
Atd002 45014
Krakow, Poland
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54
Atd002 45013
Lodz, Poland
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55
Atd002 45005
Sosnowiec, Poland
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56
Atd002 45009
Tarnów, Poland
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57
Atd002 45002
Warsaw, Poland
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58
Atd002 45004
Warsaw, Poland
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59
Atd002 45006
Warsaw, Poland
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60
Atd002 45008
Wroclaw, Poland
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61
Atd002 46004
London, United Kingdom
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62
Atd002 46007
London, United Kingdom
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63
Atd002 46003
Salford, United Kingdom
Actively Recruiting
64
Atd002 46006
Sheffield, United Kingdom
Actively Recruiting
Research Team
U
UCB Cares
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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