The purpose of this research study is to investigate if KY1005 results in improvement of eczema when given to participants with moderate to severe disease. Side effects of KY1005 will also be explored.
Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of two doses of KY1005 in adults with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
Kymab investigational site 106
Kiel, Germany
Kymab investigational site 113
Leipzig, Germany
Percentage change in Eczema Area and Severity Index (EASI)
Time frame: Baseline to day 113
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to day 113
Percentage and absolute change from Baseline in EASI over time
Time frame: Baseline to day 113
Change in epidermal thickness
Time frame: Baseline to day 113
Change in keratin 16 staining of skin biopsies
Time frame: Baseline to day 113
Percentage of patients with at least a 50% reduction in EASI (EASI 50)
Time frame: Baseline to day 113
Percentage of patients with at least a 75% reduction in EASI (EASI 75)
Time frame: Baseline to day 113
Percentage of patients with at least a 90% reduction in EASI (EASI 90)
Time frame: Baseline to day 113
Change in Validated Investigator Global Assessment (vIGA)
Time frame: Baseline to day 113
Percentage of patients with a response of vIGA 0 or 1
Time frame: Baseline to day 113
Change in SCORing of Atopic Dermatis (SCORAD) Index
Time frame: Baseline to day 113
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Kymab investigational site 207
Gdansk, Poland
Kymab investigational site 216
Katowice, Poland
Kymab investigational site 206
Krakow, Poland
Kymab investigational site 212
Krakow, Poland
Kymab investigational site 213
Krakow, Poland
Kymab investigational site 214
Krakow, Poland
Kymab investigational site 203
Olsztyn, Poland
Kymab investigational site 210
Poznan, Poland
...and 9 more locations
Change in affected body surface area (BSA)
Time frame: Baseline to day 113
Change in Patient Orientated Eczema Measure (POEM)
Time frame: Baseline to Day 113
Change in Patient Orientated SCORing of Atopic Dermatitis (PO-SCORAD) Index
Time frame: Baseline to day 113
Change in Dermatology Quality of Life Index (DLQI)
Time frame: Baseline to Day 113
Change in Numerical Rating Scale (NRS) for pruritus
Time frame: Baseline to day 113