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

Purpose

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).

Condition

  • Atopic Dermatitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Galvokimig Arm 1 		Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
  • Biological: Galvokimig
    Drug: Galvokimig Pharmaceutical form: Solution for injection
    Other names:
    • UCB9741
Experimental
Galvokimig Arm 2 		Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
  • Biological: Galvokimig
    Drug: Galvokimig Pharmaceutical form: Solution for injection
    Other names:
    • UCB9741
Experimental
Galvokimig Arm 3 		Participants will receive a predefined Galvokimig Dose during Initial Intervention Period. After week 16 participants will continue on the same or a modfied dose.
  • Biological: Galvokimig
    Drug: Galvokimig Pharmaceutical form: Solution for injection
    Other names:
    • UCB9741
Placebo Comparator
Placebo 		Participants will receive matching placebo during Initial Intervention Period. After week 16 participants will continue on the same or a dose galvokimig.
  • Biological: Galvokimig
    Drug: Galvokimig Pharmaceutical form: Solution for injection
    Other names:
    • UCB9741
  • Drug: Placebo
    Drug: Placebo Pharmaceutical form: Solution for injection

Recruiting Locations

Atd002 52015
Savannah 4221552, Georgia 4197000 31419

Atd002 52012
New Albany 4262045, Indiana 4921868 47150

Atd002 52014
Bowling Green 4285268, Kentucky 6254925 42104

Atd002 52001
Troy 5012639, Michigan 5001836 48084

Atd002 52009
Troy 5012639, Michigan 5001836 48084

Atd002 52010
Omaha 5074472, Nebraska 5073708 68144

Atd002 52020
The Bronx 5110266, New York 5128638 10455

Atd002 52005
Dallas 4684888, Texas 4736286 75230

Atd002 52011
Frisco 4692559, Texas 4736286 75034

More Details

Status
Recruiting
Sponsor
UCB Biopharma SRL

Study Contact

UCB Cares
+18445992273
ucbcares@ucb.com