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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUCB Biopharma SRL

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).

Eligibility criteria

Qualifiers

Participant must be aged greater than or equal (≥)18 years at the time of signing the informed consent

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Galvokimig
  • Placebo

Treatment groups

160 Participants
are divided into 4 treatment groups

Sponsors and collaborators