To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis

Ratio of post-baseline/baseline value of messenger ribonucleic acid (mRNA) expression in lesional skin biopsies is reported.

Time frame: 71 days

Population: The Biological Activity Set (BAS) consisted of all FAS participants who had at least 1 post-baseline skin biopsy (Visit 7, Visit 13), and received 2 doses of drug. The primary analyses on biomarkers of disease activity obtained from biopsy were based on the BAS. Participants were analyzed according to the treatment to which they were randomized.

Epidermal thickness was assessed in Hematoxylin and Eosin stained sections of lesional skin biopsies on Day 1 (baseline), Day 29, and Day 71.

Time frame: Day 1, before dosing (baseline), and Day 29 and Day 71, after dosing.

Population: The Biological Activity Set (BAS) consisted of all FAS subjects who had at least 1 post-baseline skin biopsy (Visit 7, Visit 13), and received 2 doses of study drug. The primary analyses on biomarkers of disease activity obtained from biopsy were based on the BAS. Subjects were analyzed according to the treatment to which they were randomized.

A treatment-emergent adverse event (TEAE) was defined as any new adverse event (AEs) or worsening of an existing condition after administration of the study drug up to and including the follow-up visit.

Time frame: 16 weeks

Population: The Safety Analysis Set consisted of all participants who took at least 1 full or partial dose of study treatment and were used in the assessment and reporting of safety data.

Blood samples were collected at time points to detect anti-drug antibodies (ADAs) to GBR 830, as per procedures similar to collection of PK samples. Antibodies of GBR 830 were detected and confirmed using a validated enzyme-linked immunosorbent assay (ELISA) method.

Time frame: Samples collected for immunogenicity analysis at Baseline (pre-dose), and at Day 15, Day 29 (pre-dose), Day 57, and Day 85.

Population: The Safety Analysis Set consisted of all particpants who took at least 1 full or partial dose of study treatment and were used in the assessment and reporting of safety data.

The IGA is an assessment scale used in clinical studies to determine severity of AD based on a 5-point scale ranging from 0 (clear) to 4 (severe/very severe).

Time frame: Day 4, Day 29, Day 57, Day 71

Population: N is the number of participants in the respective treatment group. Numbers and percentages calculated at each visit are based on the number of participants achieving IGA score of 0 or 1 among those evaluable participants at each visit.

In EASI, four disease characteristics of atopic dermatitis (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs, respectively. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.

Time frame: Day 4, Day 29, Day 57, Day 71

Population: Full Analysis Set (FAS): The FAS consisted of all participants who were randomized and received at least 1 partial or full dose of study treatment. The FAS population was used for the analysis of the efficacy data not obtained from skin biopsy. Participants were analyzed according to the treatment by which they were randomized.

Pharmacokinetics in terms of AUC0-tau \[Trapezoid calculation of area under the serum drug concentration-time curve from time zero (pre dose time point of the infusion) to the end of the dosing interval\] was estimated.

Time frame: Blood samples were collected on Day 1 and Day 29: pre-dose (15 mins), end of infusion (1 hour) and 1.5, 2, 72, and 504 hours post start of infusion

Population: The Pharmacokinetic Analysis Set (PKAS) consisted of the subset of the Safety Analysis Set population for which sufficient serum concentration data were available to facilitate derivation of at least 1 PK parameter, and the time (HH:MM) of dosing on the day of sampling was known for at least 1 of the dosing visits.

Pharmacokinetics in terms of Cmax (maximum observed concentration after second \[last\] dosing interval) was estimated after the first and second dose.

Time frame: Blood samples were collected on Day 1 and Day 29: pre-dose (15 mins), end of infusion (1 hour) and 1.5, 2, 72, and 504 hours post start of infusion

Population: The Pharmacokinetic Analysis Set (PKAS) consisted of the subset of the Safety Analysis Set population for which sufficient serum concentration data were available to facilitate derivation of at least 1 PK parameter, and the time (HH:MM) of dosing on the day of sampling was known for at least 1 of the dosing visits.