Trial Outcomes & Findings for A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis (NCT NCT05044234)

Last Updated: 2023-11-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

156 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2023-11-29

Participant Flow

ITT population: all randomized participants

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Overall Study STARTED	39	39	39	39
Overall Study COMPLETED	10	13	12	12
Overall Study NOT COMPLETED	29	26	27	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Overall Study Lost to Follow-up	2	1	1	2
Overall Study Withdrawal by Subject	6	4	5	8
Overall Study Study terminated by Sponsor	21	21	20	14
Overall Study Other, not specified	0	0	1	2
Overall Study Delayed data entry	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=39 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=39 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=39 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=39 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.	Total n=156 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 12.14 • n=5 Participants	49.3 years STANDARD_DEVIATION 10.13 • n=7 Participants	45.3 years STANDARD_DEVIATION 13.46 • n=5 Participants	47.5 years STANDARD_DEVIATION 12.11 • n=4 Participants	46.6 years STANDARD_DEVIATION 12.07 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	46 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	27 Participants n=4 Participants	110 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants	6 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	31 Participants n=7 Participants	24 Participants n=5 Participants	33 Participants n=4 Participants	120 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	30 Participants n=4 Participants	107 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Psoriasis Area and Severity Index (PASI) Score at Baseline	20.11 units on a scale STANDARD_DEVIATION 10.031 • n=5 Participants	19.78 units on a scale STANDARD_DEVIATION 8.698 • n=7 Participants	20.58 units on a scale STANDARD_DEVIATION 8.489 • n=5 Participants	18.24 units on a scale STANDARD_DEVIATION 8.048 • n=4 Participants	19.68 units on a scale STANDARD_DEVIATION 8.806 • n=21 Participants
Static Physicians Global Assessment (sPGA)--No. of participants with score of 3 or 4 at Baseline Baseline score of 3	32 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	35 Participants n=4 Participants	132 Participants n=21 Participants
Static Physicians Global Assessment (sPGA)--No. of participants with score of 3 or 4 at Baseline Baseline score of 4	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=13 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving 75% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 75) at Week 16	0 percentage of participants Interval 0.0 to 0.0	28.6 percentage of participants Interval 4.9 to 52.2	7.7 percentage of participants Interval 0.0 to 22.2	41.7 percentage of participants Interval 13.8 to 69.6

SECONDARY outcome

Timeframe: At Week 16

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=13 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16	0 percentage of participants Interval 0.0 to 0.0	21.4 percentage of participants Interval 0.0 to 42.9	7.7 percentage of participants Interval 0.0 to 22.2	33.3 percentage of participants Interval 6.7 to 60.0

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=13 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving 50% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 50) at Week 16	8.3 percentage of participants Interval 0.0 to 24.0	57.1 percentage of participants Interval 31.2 to 83.1	38.5 percentage of participants Interval 12.0 to 64.9	66.7 percentage of participants Interval 40.0 to 93.3

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=13 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving 90% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 90) at Week 16	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.0 to 32.6	0 percentage of participants Interval 0.0 to 0.0	33.3 percentage of participants Interval 6.7 to 60.0

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=13 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving 100% Improvement in Psoriasis Area Severity Index (PASI) Score (PASI 100) at Week 16	0 percentage of participants Interval 0.0 to 0.0	7.1 percentage of participants Interval 0.0 to 20.6	0 percentage of participants Interval 0.0 to 0.0	8.3 percentage of participants Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: Baseline, Week 16

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=13 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=12 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=11 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 for Those With PSS >0 at Baseline	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	16.7 percentage of participants Interval 0.0 to 37.8	18.2 percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Baseline, Week 16

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."

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=14 Participants Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=10 Participants Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=12 Participants Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Percentage of Participants Achieving an Itch Numerical Rating Scale (NRS) ≥4-Point Improvement From Baseline at Week 16 for Participants With Itch NRS ≥4 at Baseline	50.0 percentage of participants Interval 15.4 to 84.6	42.9 percentage of participants Interval 16.9 to 68.8	60.0 percentage of participants Interval 29.6 to 90.4	66.7 percentage of participants Interval 40.0 to 93.3

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

75 mg Cedirogant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

150 mg Cedirogant

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

375 mg Cedirogant

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=39 participants at risk Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=39 participants at risk Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=39 participants at risk Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=39 participants at risk Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.

Other adverse events

Other adverse events
Measure	Placebo n=39 participants at risk Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.	75 mg Cedirogant n=39 participants at risk Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.	150 mg Cedirogant n=39 participants at risk Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.	375 mg Cedirogant n=39 participants at risk Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.
Gastrointestinal disorders CONSTIPATION	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Gastrointestinal disorders DIARRHOEA	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Gastrointestinal disorders NAUSEA	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	7.7% 3/39 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
General disorders FATIGUE	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Infections and infestations COVID-19	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	7.7% 3/39 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	7.7% 3/39 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Infections and infestations NASOPHARYNGITIS	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	7.7% 3/39 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Skin and subcutaneous tissue disorders PRURITUS	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	2.6% 1/39 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.
Skin and subcutaneous tissue disorders PSORIASIS	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	0.00% 0/39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.	5.1% 2/39 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 109.0, 121.0, 130.0, and 103.0 days for the placebo, 75 mg cedirogant, 150 mg cedirogant and 375 mg cedirogant groups, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after the last dose; mean time on treatment was 68.2 days for the placebo group, 71.6 days for the 75 mg cedirogant group, 71.2 days for the 150 mg cedirogant group, and 61.3 days for the 375 mg cedirogant group.

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