Trial Outcomes & Findings for Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab (NCT NCT04533737)

Last Updated: 2025-03-14

Results Overview

Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Week 16, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

113 participants

Primary outcome timeframe

Week 16

Results posted on

2025-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Brodalumab + Dummy 1) Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Overall Study STARTED	56	57
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=57 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.	Total n=113 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	48 Participants n=7 Participants	101 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	51.1 years STANDARD_DEVIATION 13.6 • n=7 Participants	49.8 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	57 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Switzerland	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Greece	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Netherlands	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Sweden	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Denmark	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Italy	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment France	11 participants n=5 Participants	15 participants n=7 Participants	26 participants n=5 Participants
Region of Enrollment Germany	23 participants n=5 Participants	17 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: FAS

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having Psoriasis Area and Severity Index (PASI) 100 Response at Week 16	53.4 percentage of subjects Interval 40.0 to 66.8	35.9 percentage of subjects Interval 23.0 to 48.7

SECONDARY outcome

Timeframe: up to 28 weeks

Population: FAS

Time to having 100% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 100 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 1	0 percentage of subjects Interval 0.0 to 0.0	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 2	4.5 percentage of subjects Interval 0.8 to 13.7	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 4	22.7 percentage of subjects Interval 11.7 to 36.0	2.3 percentage of subjects Interval 0.2 to 10.7
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 6	34.1 percentage of subjects Interval 20.5 to 48.1	14.0 percentage of subjects Interval 5.6 to 26.1
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 8	40.9 percentage of subjects Interval 26.3 to 55.0	23.3 percentage of subjects Interval 11.9 to 36.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 10	45.5 percentage of subjects Interval 30.2 to 59.5	27.9 percentage of subjects Interval 15.4 to 41.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 12	61.4 percentage of subjects Interval 45.1 to 74.1	27.9 percentage of subjects Interval 15.4 to 41.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 14	61.4 percentage of subjects Interval 45.1 to 74.1	30.2 percentage of subjects Interval 17.2 to 44.3
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 16	63.6 percentage of subjects Interval 47.4 to 76.1	39.5 percentage of subjects Interval 24.9 to 53.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 18	63.6 percentage of subjects Interval 47.4 to 76.1	46.5 percentage of subjects Interval 31.0 to 60.6
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 20	65.9 percentage of subjects Interval 49.6 to 78.0	46.5 percentage of subjects Interval 31.0 to 60.6
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 22	65.9 percentage of subjects Interval 49.6 to 78.0	46.5 percentage of subjects Interval 31.0 to 60.6
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 24	68.2 percentage of subjects Interval 51.9 to 80.0	46.5 percentage of subjects Interval 31.0 to 60.6
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 26	68.2 percentage of subjects Interval 51.9 to 80.0	46.5 percentage of subjects Interval 31.0 to 60.6
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) <=100 kg Week 28	70.5 percentage of subjects Interval 54.2 to 81.9	48.8 percentage of subjects Interval 33.1 to 62.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 1	0 percentage of subjects Interval 0.0 to 0.0	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 2	8.3 percentage of subjects Interval 0.4 to 32.3	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 4	25.0 percentage of subjects Interval 5.5 to 51.6	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 6	25.0 percentage of subjects Interval 5.5 to 51.6	7.7 percentage of subjects Interval 0.4 to 30.3
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 8	41.7 percentage of subjects Interval 14.1 to 67.6	7.7 percentage of subjects Interval 0.4 to 30.3
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 10	50.0 percentage of subjects Interval 19.2 to 74.7	15.4 percentage of subjects Interval 2.2 to 39.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 12	50.0 percentage of subjects Interval 19.2 to 74.7	15.4 percentage of subjects Interval 2.2 to 39.8
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 14	58.3 percentage of subjects Interval 24.8 to 81.2	23.1 percentage of subjects Interval 5.1 to 48.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 16	58.3 percentage of subjects Interval 24.8 to 81.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 18	58.3 percentage of subjects Interval 24.8 to 81.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 20	58.3 percentage of subjects Interval 24.8 to 81.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 22	58.3 percentage of subjects Interval 24.8 to 81.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 24	66.7 percentage of subjects Interval 30.2 to 87.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 26	66.7 percentage of subjects Interval 30.2 to 87.2	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 100 Response (Summarized as the Cumulative Incidence for Achieving PASI 100 at Each Timepoint, Stratified by Weight) >100 kg Week 28	66.7 percentage of subjects Interval 30.2 to 87.2	30.8 percentage of subjects Interval 8.8 to 56.5

SECONDARY outcome

Timeframe: up to 28 weeks

Population: FAS

Time to having 90% improvement from baseline in PASI score. The outcome measure summarizes the cumulative percentage of subjects with PASI 90 response (stratified by weight) over time, based on the Aalen-Johansen estimator. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 1	0 percentage of subjects Interval 0.0 to 0.0	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 2	6.8 percentage of subjects Interval 1.7 to 16.9	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 4	27.3 percentage of subjects Interval 15.1 to 41.0	9.3 percentage of subjects Interval 2.9 to 20.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 6	56.8 percentage of subjects Interval 40.8 to 70.0	23.3 percentage of subjects Interval 11.9 to 36.8
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 8	65.9 percentage of subjects Interval 49.6 to 78.0	34.9 percentage of subjects Interval 21.0 to 49.1
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 10	68.2 percentage of subjects Interval 51.9 to 79.9	39.5 percentage of subjects Interval 24.9 to 53.8
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 12	72.7 percentage of subjects Interval 56.6 to 83.7	41.9 percentage of subjects Interval 26.9 to 56.1
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 14	72.7 percentage of subjects Interval 56.6 to 83.7	44.2 percentage of subjects Interval 29.0 to 58.4
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 16	75.0 percentage of subjects Interval 59.0 to 85.5	48.8 percentage of subjects Interval 33.1 to 62.8
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 18	75.0 percentage of subjects Interval 59.0 to 85.5	51.2 percentage of subjects Interval 35.3 to 65.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 20	81.8 percentage of subjects Interval 66.2 to 90.7	55.8 percentage of subjects Interval 39.6 to 69.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 22	81.8 percentage of subjects Interval 66.2 to 90.7	55.8 percentage of subjects Interval 39.6 to 69.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 24	81.8 percentage of subjects Interval 66.2 to 90.7	55.8 percentage of subjects Interval 39.6 to 69.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 26	81.8 percentage of subjects Interval 66.2 to 90.7	55.8 percentage of subjects Interval 39.6 to 69.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) <=100 kg Week 28	81.8 percentage of subjects Interval 66.2 to 90.7	55.8 percentage of subjects Interval 39.6 to 69.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 1	0 percentage of subjects Interval 0.0 to 0.0	0 percentage of subjects Interval 0.0 to 0.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 2	16.7 percentage of subjects Interval 2.4 to 42.4	7.7 percentage of subjects Interval 0.4 to 30.3
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 4	33.3 percentage of subjects Interval 9.4 to 60.0	15.4 percentage of subjects Interval 2.2 to 39.8
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 6	58.3 percentage of subjects Interval 25.1 to 81.1	23.1 percentage of subjects Interval 5.1 to 48.5
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 8	58.3 percentage of subjects Interval 25.1 to 81.1	23.1 percentage of subjects Interval 5.1 to 48.5
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 10	58.3 percentage of subjects Interval 25.1 to 81.1	23.1 percentage of subjects Interval 5.1 to 48.5
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 12	58.3 percentage of subjects Interval 25.1 to 81.1	23.1 percentage of subjects Interval 5.1 to 48.5
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 14	66.7 percentage of subjects Interval 30.8 to 87.0	30.8 percentage of subjects Interval 8.8 to 56.5
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 16	66.7 percentage of subjects Interval 30.8 to 87.0	46.2 percentage of subjects Interval 17.9 to 70.7
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 18	66.7 percentage of subjects Interval 30.8 to 87.0	46.2 percentage of subjects Interval 17.9 to 70.7
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 20	66.7 percentage of subjects Interval 30.8 to 87.0	46.2 percentage of subjects Interval 17.9 to 70.7
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 24	75.0 percentage of subjects Interval 35.5 to 92.3	53.8 percentage of subjects Interval 23.1 to 77.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 26	75.0 percentage of subjects Interval 35.5 to 92.3	53.8 percentage of subjects Interval 23.1 to 77.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 28	75.0 percentage of subjects Interval 35.5 to 92.3	53.8 percentage of subjects Interval 23.1 to 77.0
Time to PASI 90 Response (Summarized as the Cumulative Incidence for Achieving PASI 90 at Each Timepoint, Stratified by Weight) >100 kg Week 22	75.0 percentage of subjects Interval 35.5 to 92.3	46.2 percentage of subjects Interval 17.9 to 70.7

SECONDARY outcome

Timeframe: Weeks 4, 8, and 28

Population: FAS

Having 100% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 100 response at Weeks 4, 8, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses the extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. Week 4	23.3 percentage of participants Interval 12.0 to 34.6	1.9 percentage of participants Interval -1.8 to 5.6
Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. Week 8	40.8 percentage of participants Interval 27.5 to 54.1	16.5 percentage of participants Interval 6.5 to 26.4
Having PASI 100 Response, Assessed Separately at Weeks 4, 8, and 28. Week 28	61.4 percentage of participants Interval 48.3 to 74.5	36.8 percentage of participants Interval 23.9 to 49.8

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, and 28

Population: FAS

Having 90% improvement from baseline in PASI score. The outcome measure is summarized using the least squares mean percentage of subjects having PASI 90 response at Weeks 4, 8, 16, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline PASI score. The PASI is the most widely used tool in clinical practice and clinical trials to assess psoriasis severity and extent. Assessment is done based on the condition of the disease at the time of evaluation, not in relation to the condition at a previous visit. The investigator assesses the severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions (head/neck, trunk, upper extremities, lower extremities) according to a severity scale. The investigator also assesses extent of psoriasis within each of the 4 body regions. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe/extensive condition.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. Week 4	28.7 percentage of participants Interval 16.7 to 40.8	9.2 percentage of participants Interval 1.4 to 16.9
Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. Week 8	60.2 percentage of participants Interval 46.8 to 73.7	24.9 percentage of participants Interval 13.1 to 36.7
Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. Week 16	69.1 percentage of participants Interval 56.7 to 81.5	45.2 percentage of participants Interval 31.8 to 58.6
Having PASI 90 Response, Assessed Separately at Weeks 4, 8, 16, and 28. Week 28	69.8 percentage of participants Interval 57.4 to 82.2	44.7 percentage of participants Interval 31.2 to 58.2

SECONDARY outcome

Timeframe: Weeks 16 and 28

Population: FAS

Having a score of 0 (clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. Week 16	55.5 percentage of participants Interval 42.3 to 68.7	35.6 percentage of participants Interval 22.8 to 48.3
Having Investigator's Global Assessment (IGA) of 0, Assessed Separately at Weeks 16 and 28. Week 28	62.4 percentage of participants Interval 49.5 to 75.3	41.2 percentage of participants Interval 28.1 to 54.3

SECONDARY outcome

Timeframe: Weeks 16 and 28

Population: FAS

Having a score of 0 (clear) or 1 (almost clear) in IGA. The outcome measure is summarized using the least squares mean percentage of subjects having an IGA score of 0 or 1 at Weeks 16 and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline IGA score. The IGA is an instrument used in clinical trials to rate the severity of psoriasis and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. Week 16	78.5 percentage of participants Interval 67.5 to 89.5	52.5 percentage of participants Interval 39.1 to 66.0
Having IGA of 0 or 1, Assessed Separately at Weeks 16 and 28. Week 28	82.1 percentage of participants Interval 71.8 to 92.4	65.4 percentage of participants Interval 52.7 to 78.2

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, and 28

Population: FAS

The outcome measure is summarized using the least squares mean percentage of subjects having a DLQI score of 0 or 1 at Weeks 4, 8, 12, 16, 20, 24, and 28, based on a logistic regression model adjusted for baseline body weight (\<=100 kg,\>100 kg) and baseline DLQI score. The DLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all/not relevant'; 1 = 'a little'; 2 = 'a lot'; 3 = 'very much'). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 4	67.8 percentage of participants Interval 54.9 to 80.8	34.3 percentage of participants Interval 21.1 to 47.6
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 8	68.8 percentage of participants Interval 56.2 to 81.3	66.8 percentage of participants Interval 53.7 to 79.8
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 12	78.4 percentage of participants Interval 66.8 to 89.9	66.0 percentage of participants Interval 52.7 to 79.2
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 16	80.2 percentage of participants Interval 69.7 to 90.8	71.6 percentage of participants Interval 59.7 to 83.4
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 28	79.3 percentage of participants Interval 68.3 to 90.3	66.6 percentage of participants Interval 53.9 to 79.3
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 20	80.0 percentage of participants Interval 69.0 to 90.9	68.9 percentage of participants Interval 56.3 to 81.4
Having Dermatology Life Quality Index (DLQI) Total Score of 0 or 1, Assessed Separately at Weeks 4, 8, 12, 16, 20, 24, and 28. Week 24	75.7 percentage of participants Interval 64.0 to 87.3	70.6 percentage of participants Interval 58.3 to 82.9

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, and 28

Population: FAS

The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The physical component summary score ranges from 5.1 to 79.7. Higher scores indicate better outcome.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 4	3.3 score on a scale Interval 1.9 to 4.7	1.9 score on a scale Interval 0.4 to 3.3
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 8	3.8 score on a scale Interval 2.5 to 5.1	3.0 score on a scale Interval 1.6 to 4.4
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 16	4.2 score on a scale Interval 2.7 to 5.6	3.7 score on a scale Interval 2.2 to 5.1
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 28	3.9 score on a scale Interval 2.5 to 5.3	3.9 score on a scale Interval 2.5 to 5.3

SECONDARY outcome

Timeframe: Weeks 4, 8, 16, and 28

Population: FAS

The SF-36v2 is a 36-item general health status assessment. Participants answer each question by selecting 1 of 3 to 6 categorical response options. The SF-36v2 yields scores for 8 health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) and 2 psychometrically derived summary scores (a physical component summary and a mental component summary). The mental component summary score ranges from -4.0 to 79.7. Higher scores indicate better outcome.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 4	2.7 score on a scale Interval 1.3 to 4.1	2.6 score on a scale Interval 1.2 to 4.0
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 8	3.8 score on a scale Interval 2.3 to 5.2	3.7 score on a scale Interval 2.2 to 5.2
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 16	3.0 score on a scale Interval 1.5 to 4.4	3.6 score on a scale Interval 2.1 to 5.1
Change in 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Component Score From Baseline, Assessed Separately at Weeks 4, 8, 16, and 28. Week 28	3.1 score on a scale Interval 1.3 to 4.9	4.0 score on a scale Interval 2.2 to 5.8

SECONDARY outcome

Timeframe: From baseline to Week 28

Population: Safety analysis set

An adverse event is considered treatment-emergent if the onset occurred after the first administration of IMP or if the event started prior to the first administration of IMP and worsened in severity after the first administration of IMP.

Outcome measures

Outcome measures
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 Participants Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 Participants Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Occurrence of Treatment-emergent Adverse Events (AEs) From Baseline to Week 28.	42 Participants	31 Participants

Adverse Events

Arm 1 (Brodalumab + Dummy 1)

Serious events: 4 serious events

Other events: 37 other events

Deaths: 0 deaths

Arm 2 (Guselkumab + Dummy 2)

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 participants at risk Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 participants at risk Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Nervous system disorders Syncope	3.6% 2/56 • Number of events 2 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Infections and infestations Infection	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Psychiatric disorders Suicidal ideation	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Psychiatric disorders Alcohol abuse	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events
Hepatobiliary disorders Hepatic mass	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events
Vascular disorders Arterial stenosis	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events

Other adverse events

Other adverse events
Measure	Arm 1 (Brodalumab + Dummy 1) n=56 participants at risk Participants receive: * Brodalumab 210 mg (1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. * Dummy 1 (placebo 1.0 ml) at Weeks 0, 4, and then every 8 weeks. Brodalumab: Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active guselkumab solution except that it does not contain any active substance.	Arm 2 (Guselkumab + Dummy 2) n=56 participants at risk Participants receive: * Guselkumab 100 mg (1.0 ml) at Weeks 0, 4, and then every 8 weeks. * Dummy 2 (placebo 1.5 ml) at Weeks 0, 1, 2, and then every 2 weeks. Guselkumab: Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection. Placebo: The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 10/56 • Number of events 14 • 28 Weeks Treatment-emergent adverse events	3.6% 2/56 • Number of events 4 • 28 Weeks Treatment-emergent adverse events
Musculoskeletal and connective tissue disorders Back pain	8.9% 5/56 • Number of events 5 • 28 Weeks Treatment-emergent adverse events	1.8% 1/56 • Number of events 1 • 28 Weeks Treatment-emergent adverse events
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 4/56 • Number of events 4 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Musculoskeletal and connective tissue disorders Myalgia	5.4% 3/56 • Number of events 4 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Infections and infestations COVID-19	14.3% 8/56 • Number of events 8 • 28 Weeks Treatment-emergent adverse events	10.7% 6/56 • Number of events 6 • 28 Weeks Treatment-emergent adverse events
Infections and infestations Nasopharyngitis	12.5% 7/56 • Number of events 7 • 28 Weeks Treatment-emergent adverse events	7.1% 4/56 • Number of events 4 • 28 Weeks Treatment-emergent adverse events
Skin and subcutaneous tissue disorders Psoriasis	5.4% 3/56 • Number of events 3 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
Gastrointestinal disorders Dyspepsia	5.4% 3/56 • Number of events 3 • 28 Weeks Treatment-emergent adverse events	0.00% 0/56 • 28 Weeks Treatment-emergent adverse events
General disorders Fatigue	3.6% 2/56 • Number of events 2 • 28 Weeks Treatment-emergent adverse events	5.4% 3/56 • Number of events 3 • 28 Weeks Treatment-emergent adverse events
Nervous system disorders Headache	8.9% 5/56 • Number of events 10 • 28 Weeks Treatment-emergent adverse events	5.4% 3/56 • Number of events 4 • 28 Weeks Treatment-emergent adverse events
Psychiatric disorders Depression	5.4% 3/56 • Number of events 3 • 28 Weeks Treatment-emergent adverse events	8.9% 5/56 • Number of events 5 • 28 Weeks Treatment-emergent adverse events
Vascular disorders Hypertension	8.9% 5/56 • Number of events 5 • 28 Weeks Treatment-emergent adverse events	3.6% 2/56 • Number of events 2 • 28 Weeks Treatment-emergent adverse events

Additional Information

Clinical Disclosure

LEO Pharma A/S

Phone: +45 44 94 58 88

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all phase 3 clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
Publication restrictions are in place

Restriction type: OTHER