Galvokimig dose-ranging for adults with moderate-to-severe atopic dermatitis
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
This trial tests different doses of galvokimig versus placebo to see if it reduces symptoms in adults with moderate-to-severe atopic dermatitis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UCB Pharma Industry-sponsored |
| Drugs / interventions | dupilumab, tralokinumab, lebrikizumab |
| Locations | 57 sites (Oceanside, California and 56 other locations) |
| Trial ID | NCT07277660 on ClinicalTrials.gov |
What this trial studies
This Phase 2 dose-ranging trial compares multiple doses of galvokimig with placebo in adults who have moderate-to-severe atopic dermatitis. Eligible participants meeting severity thresholds (vIGA ≥3, EASI ≥16, PP-NRS ≥4, and ≥10% BSA) and with inadequate response to topical therapies will be assigned to receive galvokimig or placebo and followed over time. The study collects measures of symptom relief, skin lesion improvement, itch scores, and drug pharmacokinetics/pharmacodynamics, alongside safety monitoring. Results will be used to define the dose–response relationship and inform selection of doses for later studies.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic moderate-to-severe atopic dermatitis who meet vIGA ≥3, EASI ≥16, PP-NRS ≥4, have ≥10% BSA involvement, and have had an inadequate response to topical treatments are the intended participants.
Not a fit: Patients with mild atopic dermatitis, children under 18, those who respond well to topical therapy, or those with contraindications to the investigational drug are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, galvokimig could offer a new systemic option that reduces inflammation and itch and improves skin clearance for adults with moderate-to-severe atopic dermatitis.
How similar studies have performed: Other biologic and JAK-inhibitor therapies for atopic dermatitis have shown clear clinical benefits, but galvokimig is a newer agent with limited public Phase 2 data so far.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
Oceanside, California and 56 other locations
- Atd002 52021 — Oceanside, California, United States (Recruiting)
- Atd002 52008 — Santa Monica, California, United States (Recruiting)
- Atd002 52013 — Boca Raton, Florida, United States (Recruiting)
- Atd002 52007 — Coral Gables, Florida, United States (Recruiting)
- Atd002 52003 — Miami, Florida, United States (Recruiting)
- Atd002 52015 — Savannah, Georgia, United States (Recruiting)
- Atd002 52017 — Chicago, Illinois, United States (Recruiting)
- Atd002 52018 — Wheaton, Illinois, United States (Recruiting)
- Atd002 52012 — New Albany, Indiana, United States (Recruiting)
- Atd002 52014 — Bowling Green, Kentucky, United States (Recruiting)
- Atd002 52001 — Troy, Michigan, United States (Recruiting)
- Atd002 52009 — Troy, Michigan, United States (Recruiting)
- Atd002 52010 — Omaha, Nebraska, United States (Recruiting)
- Atd002 52020 — The Bronx, New York, United States (Recruiting)
- Atd002 52019 — Philadelphia, Pennsylvania, United States (Recruiting)
- Atd002 52005 — Dallas, Texas, United States (Recruiting)
- Atd002 52016 — Frisco, Texas, United States (Recruiting)
- Atd002 52011 — Frisco, Texas, United States (Recruiting)
- Atd002 52004 — Sugar Land, Texas, United States (Recruiting)
- Atd002 41004 — Lovech, Bulgaria (Recruiting)
- Atd002 41001 — Pleven, Bulgaria (Recruiting)
- Atd002 41007 — Plovdiv, Bulgaria (Recruiting)
- Atd002 41002 — Sevlievo, Bulgaria (Recruiting)
- Atd002 41005 — Sofia, Bulgaria (Recruiting)
- Atd002 41006 — Sofia, Bulgaria (Recruiting)
- Atd002 51006 — Hamilton, Canada (Recruiting)
- Atd002 51007 — Toronto, Canada (Recruiting)
- Atd002 42002 — Náchod, Czechia (Recruiting)
- Atd002 42001 — Prague, Czechia (Recruiting)
- Atd002 42004 — Prague, Czechia (Recruiting)
- Atd002 42005 — Prague, Czechia (Recruiting)
- Atd002 43001 — Bad Bentheim, Germany (Recruiting)
- Atd002 43002 — Frankfurt, Germany (Recruiting)
- Atd002 43004 — Leipzig, Germany (Recruiting)
- Atd002 43007 — Mahlow, Germany (Recruiting)
- Atd002 44003 — Budapest, Hungary (Recruiting)
- Atd002 21001 — Habikino, Japan (Recruiting)
- Atd002 21007 — Nagoya, Japan (Recruiting)
- Atd002 21005 — Sakai, Japan (Recruiting)
- Atd002 21008 — Sapporo, Japan (Recruiting)
- Atd002 21004 — Tachikawa-shi, Japan (Recruiting)
- Atd002 21006 — Yokohama, Japan (Recruiting)
- Atd002 45001 — Katowice, Poland (Recruiting)
- Atd002 45003 — Krakow, Poland (Recruiting)
- Atd002 45007 — Krakow, Poland (Recruiting)
- Atd002 45010 — Krakow, Poland (Recruiting)
- Atd002 45014 — Krakow, Poland (Recruiting)
- Atd002 45013 — Lodz, Poland (Recruiting)
- Atd002 45005 — Sosnowiec, Poland (Recruiting)
- Atd002 45009 — Tarnów, Poland (Recruiting)
+7 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: UCB Cares
- Email: ucbcares@ucb.com
- Phone: +18445992273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.