A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
Recruiting · NCT07277660 · Interventional (participants receive a specific treatment) · Lead sponsor: UCB Biopharma SRL
View the official record on ClinicalTrials.gov →Interventions studied
GalvokimigPlacebo
What this trial is about
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
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 11 US states.
- Atd002 52021 - Oceanside, California, United States
- Atd002 52008 - Santa Monica, California, United States
- Atd002 52013 - Boca Raton, Florida, United States
- Atd002 52007 - Miami, Florida, United States
- Atd002 52003 - Miami, Florida, United States
- Atd002 52015 - Savannah, Georgia, United States
- Atd002 52017 - Chicago, Illinois, United States
- Atd002 52018 - Wheaton, Illinois, United States
- Atd002 52012 - New Albany, Indiana, United States
- Atd002 52014 - Bowling Green, Kentucky, United States
- Atd002 52001 - Troy, Michigan, United States
- Atd002 52009 - Troy, Michigan, United States
- Atd002 52010 - Omaha, Nebraska, United States
- Atd002 52022 - New York, New York, United States
- Atd002 52020 - The Bronx, New York, United States
- Atd002 52019 - Philadelphia, Pennsylvania, United States
- Atd002 52005 - Dallas, Texas, United States
- Atd002 52016 - Frisco, Texas, United States
- Atd002 52011 - Frisco, Texas, United States
- Atd002 52004 - Sugar Land, Texas, United States
- Atd002 43001 - Bad Bentheim, Germany
- Atd002 44003 - Budapest, Hungary
- Atd002 45011 - Chorzów, Poland
- Atd002 44001 - Debrecen, Hungary
- Atd002 43005 - Dresden, Germany
- Atd002 51002 - Edmonton, Canada
- Atd002 43002 - Frankfurt, Germany
- Atd002 21001 - Habikino, Japan
- Atd002 51006 - Hamilton, Canada
- Atd002 45001 - Katowice, Poland
- Atd002 45003 - Krakow, Poland
- Atd002 45007 - Krakow, Poland
- Atd002 45010 - Krakow, Poland
- Atd002 45014 - Krakow, Poland
- Atd002 43004 - Leipzig, Germany
- Atd002 45004 - Lodz, Poland
- Atd002 45013 - Lodz, Poland
- Atd002 46004 - London, United Kingdom
- Atd002 46007 - London, United Kingdom
- Atd002 41004 - Lovech, Bulgaria
- Atd002 43003 - Lübeck, Germany
- Atd002 43007 - Mahlow, Germany
- Atd002 21002 - Nagasaki, Japan
- Atd002 21007 - Nagoya, Japan
- Atd002 42002 - Náchod, Czechia
- Atd002 41001 - Pleven, Bulgaria
- Atd002 41007 - Plovdiv, Bulgaria
- Atd002 42001 - Prague, Czechia
- Atd002 42003 - Prague, Czechia
- Atd002 42004 - Prague, Czechia
- Atd002 42005 - Prague, Czechia
- Atd002 21005 - Sakai, Japan
- Atd002 46003 - Salford, United Kingdom
- Atd002 21008 - Sapporo, Japan
- Atd002 41002 - Sevlievo, Bulgaria
- Atd002 46006 - Sheffield, United Kingdom
- Atd002 41003 - Sofia, Bulgaria
- Atd002 41005 - Sofia, Bulgaria
- Atd002 41006 - Sofia, Bulgaria
- Atd002 45005 - Sosnowiec, Poland
Showing 60 of 68 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →