A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The itch NRS is an 11-point scale that participants completed to describe the intensity of their itch using a 24-hour recall period. The itch NRS asked the participants to: Please rate your itching severity due to your psoriasis by circling the number that best describes your worst level of itching in the past 24 hours? The itch NRS scale scores vary between 0, representing no itching and 10, representing worst itch imaginable.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The static Physicians Global Assessment (sPGA) is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5.

Time frame: At Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.

The PSS is a 4-item patient-reported outcome (PRO) instrument that assesses the severity of psoriasis symptoms in participants with moderate to severe psoriasis. The symptoms included are: pain, redness, itching and burning from psoriasis. Current symptom severity is assessed as a daily diary, using a 5-point scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms.

Time frame: Baseline, Week 16

Population: ITT population; the Observed Cases (OC) approach was used to handle missing data-- values for missing evaluations were not imputed, and a participant who had an evaluation on a scheduled visit was included in the OC analysis for that visit.