BridgeMD
Tests treatment safety and results for Atopic Dermatitis
Official title A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
ClinicalTrials.gov ID: NCT07277660
What this study is testing
What is Galvokimig?
Galvokimig is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for atopic dermatitis.
Also referred to as UCB9741.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or...
- Active dermatologic conditions that may confound the diagnosis of AtD or would interfere with assessment of treatment, such as but not limited to...
- 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...
- Participants are not permitted to enroll into the study if they meet tuberculosis (TB) exclusion criteria
- Previous treatment with galvokimig
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oceanside, California, United States
- Santa Monica, California, United States
- Boca Raton, Florida, United States
- Miami, Florida, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Wheaton, Illinois, United States
- New Albany, Indiana, United States
- Bowling Green, Kentucky, United States
- Troy, Michigan, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- The Bronx, New York, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Frisco, Texas, United States
- Sugar Land, Texas, United States
- Lovech, Bulgaria
- Pleven, Bulgaria
- Plovdiv, Bulgaria
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oceanside, California, United States; Santa Monica, California, United States; Boca Raton, Florida, United States; Miami, Florida, United States; Savannah, Georgia, United States; Chicago, Illinois, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.