IXORA-R: A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03573323
• Collaborator: (none)
• Enrollment: 1,027
• Locations: 124
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site: 8.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: Ixekizumab; Drug: Guselkumab; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1027 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis
• Actual Study Start Date: Nov 9, 2018
• Actual Primary Completion Date: Jul 15, 2019
• Actual Study Completion Date: Jan 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ixekizumab A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	Drug: Ixekizumab; Administered SC; Other Names: LY2439821
Experimental: Guselkumab During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	Drug: Guselkumab; Administered SC; Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) [Week 12]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Secondary Outcome Measures

1. Percentage of Participants Achieving PASI 75 [Week 2]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.

2. Percentage of Participants Achieving PASI 90 [Week 4]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

3. Percentage of Participants Achieving PASI 100 [Week 4]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

4. Percentage of Participants Achieving PASI 90 [Week 8]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.

5. Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0) [Week 12]

   The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.

6. Percentage of Participants Achieving PASI 50 [Week 1]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.

7. Percentage of Participants Achieving PASI 100 [Week 8]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

8. Percentage of Participants Achieving PASI 100 [Week 24]

   The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.

• Are a candidate for phototherapy and/or systemic therapy.

• Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.

• Have ≥10% body surface area (BSA) involvement at screening and baseline.

• If a male, agree to use a reliable method of birth control during the study.

• If female, agree to use highly effective method of contraception.

Exclusion Criteria:

• Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.

• Have a history of drug-induced psoriasis.

• Had a clinically significant flare of psoriasis during the 12 weeks before baseline.

• Use of tanning booths for at least 4 weeks before baseline.

• Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; secukinumab <5 months; or any other biologic agent (e.g., ustekinumab) <5 half lives.

• Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.

• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.

• Have previously failed to respond to an IL-17 antagonist, per investigator assessment.

• Have had a live vaccination within 12 weeks of baseline.

• Have a known allergy or hypersensitivity to any biologic therapy.

• Have had any major surgery within 8 weeks of baseline.

• Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.

• Are women who are pregnant, or who are lactating (breast-feeding).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Dermatology Center PC	Birmingham	Alabama	United States	35205
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
3	Alliance Dermatology and Mohs Center	Phoenix	Arizona	United States	85032
4	Perseverance Research Center	Scottsdale	Arizona	United States	85254
5	Johnson Dermatology	Fort Smith	Arkansas	United States	72916
6	Bakersfield Dermatology and Skin Cancer Medical Group	Bakersfield	California	United States	93309
7	Wallace Medical Group, Inc.	Beverly Hills	California	United States	90211
8	California Dermatology and Clinical Research Institute	Encinitas	California	United States	92024
9	Tien Q. Nguyen, MD inc. DBA First OC Dermatology	Fountain Valley	California	United States	92708
10	Center for Dermatology Clinical Research, Inc.	Fremont	California	United States	94538
11	Advanced Research Center	Los Alamitos	California	United States	90720
12	Axis Clinical Trials	Los Angeles	California	United States	90036
13	Dermatology Clinical Trials	Newport Beach	California	United States	92660
14	Quest Dermatology Research	Northridge	California	United States	91324
15	Northern California Research Corporation	Sacramento	California	United States	95821
16	Advanced Research Center	San Diego	California	United States	92103
17	Medical Center for Clinical Research	San Diego	California	United States	92108
18	University Clinical Trials, Inc.	San Diego	California	United States	92123
19	Synergy Dermatology	San Francisco	California	United States	94132
20	Southern California Dermatology	Santa Ana	California	United States	92701
21	Mosaic Dermatology	Santa Monica	California	United States	90403
22	Clinical Science Institute	Santa Monica	California	United States	90404
23	Unison Clinical Trials	Sherman Oaks	California	United States	91403
24	Care Access Research-Walnut Creek	Walnut Creek	California	United States	94598
25	Dermatology Physicians of Connecticut	Shelton	Connecticut	United States	06484
26	Florida Academic Dermatology Centers	Coral Gables	Florida	United States	33134
27	Olympian Clinical Research	Largo	Florida	United States	33770
28	Suncoast Research Group, LLC	Miami	Florida	United States	33135
29	Miami Dermatology & Laser Research	Miami	Florida	United States	33173
30	Suncoast Clinical Research	New Port Richey	Florida	United States	34652
31	Renstar Medical Research	Ocala	Florida	United States	34470
32	Sensible Healthcare	Ocoee	Florida	United States	34761
33	Park Avenue Dermatology	Orange Park	Florida	United States	32073
34	International Clinical Research	Sanford	Florida	United States	32771
35	MOORE Clinical Research	Tampa	Florida	United States	33609
36	ForCare Clinical Research	Tampa	Florida	United States	33613
37	Olympian Clinical Research	Tampa	Florida	United States	33614
38	Atlanta Dermatology, Vein Research Center, PC	Alpharetta	Georgia	United States	30022
39	Skin Care Physicians of Georgia	Macon	Georgia	United States	31217
40	Arlington Dermatology	Rolling Meadows	Illinois	United States	60008
41	Dermatology Institute of Dupage Medical Group	Wheaton	Illinois	United States	60189
42	Qualmedica Research LLC	Evansville	Indiana	United States	47715
43	Dawes Fretzin Clinical Research	Indianapolis	Indiana	United States	46250
44	Dermatology Specialists Research Indiana	New Albany	Indiana	United States	47150
45	The Indiana Clinical Trials Center, PC	Plainfield	Indiana	United States	46168
46	The South Bend Clinic	South Bend	Indiana	United States	46617
47	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa	United States	50265
48	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
49	Dermatology Specialist	Louisville	Kentucky	United States	40241
50	Owensboro Dermatology Associates	Owensboro	Kentucky	United States	42303
51	Lawrence J Green, M.D, LLC	Rockville	Maryland	United States	20850
52	ActivMed Practices & Research, Inc	Beverly	Massachusetts	United States	01915
53	Fivenson Dermatology	Ann Arbor	Michigan	United States	48103
54	Great Lakes Research Group, Inc.	Bay City	Michigan	United States	48706
55	Clarkston Skin Research	Clarkston	Michigan	United States	48346
56	Henry Ford Medical Center- New Center One	Detroit	Michigan	United States	48202
57	St Joseph Dermatology and Vein Clinic	Saint Joseph	Michigan	United States	49085
58	Central Dermatology PC	Saint Louis	Missouri	United States	63117
59	Impact Clinical Trials	Las Vegas	Nevada	United States	89106
60	ActivMed Practices & Research, Inc	Portsmouth	New Hampshire	United States	03801
61	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey	United States	08520
62	Forest Hills Dermatology Group	Forest Hills	New York	United States	11375
63	Sadick Research Group	New York	New York	United States	10075
64	Piedmont Plastic Surgery and Dermatology	Charlotte	North Carolina	United States	28277
65	Dermatology Consulting Services	High Point	North Carolina	United States	27262
66	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina	United States	27804
67	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28411
68	Bexley Dermatology Research	Bexley	Ohio	United States	43209
69	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
70	Wright State Univ School of Medicine	Fairborn	Ohio	United States	45324
71	Ohio State Univ College Of Medicine	Gahanna	Ohio	United States	43230
72	Dermatologists of Southwest Ohio, Inc.	Mason	Ohio	United States	45040
73	Oregon Medical Research Center	Portland	Oregon	United States	97223
74	Dermatology and Skin Surgery Center	Exton	Pennsylvania	United States	19341
75	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
76	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
77	Yardley Dermatology	Yardley	Pennsylvania	United States	19067
78	Clinical Partners LLC	Johnston	Rhode Island	United States	02919
79	Clinical Research Center of the Carolinas	Charleston	South Carolina	United States	29407
80	International Clinical Research	Murfreesboro	Tennessee	United States	37130
81	Arlington Research Center, Inc	Arlington	Texas	United States	76011
82	Austin Institute for Clinical Research, Inc.	Austin	Texas	United States	78705
83	Bellaire Dermatology	Bellaire	Texas	United States	77401
84	Dermatology Treatment and Research Center	Dallas	Texas	United States	75230
85	Modern Research Associates PLLC	Dallas	Texas	United States	75231
86	Center for Clinical Studies	Houston	Texas	United States	77004
87	Suzanne Bruce and Associates, PA	Houston	Texas	United States	77056
88	Progressive Clinical Research	San Antonio	Texas	United States	78213
89	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
90	Stephen L Miller, MD, PA	San Antonio	Texas	United States	78249
91	University of Utah MidValley Dematology	Murray	Utah	United States	84107
92	Virginia Clinical Research	Norfolk	Virginia	United States	23502
93	Virginia Dermatology & Skin Cancer Center	Norfolk	Virginia	United States	23502
94	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
95	National Clinical Research - Richmond	Richmond	Virginia	United States	23294
96	Dermatology Associates	Seattle	Washington	United States	98101
97	West Virginia Research Institute	Morgantown	West Virginia	United States	26505
98	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
99	Dermatology Research Institute Inc.	Calgary	Alberta	Canada	T1Y 0B4
100	Kirk Barber Research	Calgary	Alberta	Canada	T2G 1B1
101	Stratica Medical	Edmonton	Alberta	Canada	T5K 1X3
102	Dr. Chih-ho Hong Medical Inc.	Surrey	British Columbia	Canada	V3R 6A7
103	Enverus Medical Research	Surrey	British Columbia	Canada	V3V 0C6
104	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba	Canada	R3M 3Z4
105	Karma Clinical Trials Inc	St. John's	Newfoundland and Labrador	Canada	A1A 4Y3
106	Eastern Canada Cutaneous Research Assoicates Ltd	Halifax	Nova Scotia	Canada	B3H1Z2
107	Dermatrials Research Inc.	Hamilton	Ontario	Canada	L8N 1Y2
108	Mediprobe Research Inc	London	Ontario	Canada	N5X 2P1
109	The Guenther Dermatology Research Centre	London	Ontario	Canada	N6A 3H7
110	Lynderm Research Inc	Markham	Ontario	Canada	L3P1X2
111	DermEdge Research Inc	Mississauga	Ontario	Canada	L5H 1G9
112	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
113	SKiN Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
114	The Centre for Dermatology	Richmond Hill	Ontario	Canada	L4B 1A5
115	K. Papp Clinical Research Inc	Waterloo	Ontario	Canada	N2J 1C4
116	Dr Isabelle Delorme Inc.	Drummondville	Quebec	Canada	J2B 5L4
117	Innovaderm Research Inc	Montreal	Quebec	Canada	H2K4L5
118	Q&T Research Sherbrooke Inc	Sherbrooke	Quebec	Canada	J1J 2G2
119	Santa Cruz Behavioral PSC	Bayamón		Puerto Rico	00961-6911
120	Centro Reumatologico de Caguas	Caguas		Puerto Rico	00725
121	Office of Dr. Samuel Sanchez PSC	Caguas		Puerto Rico	00727
122	Ponce School of Medicine CAIMED Center	Ponce		Puerto Rico	00716
123	GCM Medical Group PSC	San Juan		Puerto Rico	00909
124	Mindful Medical Research	San Juan		Puerto Rico	00918

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Dec 7, 2018
• Statistical Analysis Plan - Jul 31, 2019

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03573323
• Other Study ID Numbers: 17119; I1F-MC-RHCR
• First Posted: Jun 29, 2018
• Last Update Posted: Jul 28, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: biologic; biologic therapy
• Additional relevant MeSH terms: Psoriasis; Ixekizumab

Study Results

Participant Flow

Pre-assignment Detail	The study consists of a combined blinded treatment (trt) period with a 24-week duration followed by a post treatment follow-up (PTFU) period with a minimum of a 12-week duration. The Induction Dosing Period (12 Weeks) and Extension Period (12 Weeks) were combined for analysis and referred to as the blinded treatment periods.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Period Title: Blinded Treatment Period (Weeks 0-24)
STARTED	520	507
Received at Least One Dose of Study Drug	519	506
COMPLETED	465	459
NOT COMPLETED	55	48
Period Title: Blinded Treatment Period (Weeks 0-24)
STARTED	465	456
COMPLETED	406	399
NOT COMPLETED	59	57

Baseline Characteristics

Arm/Group Title	Ixekizumab	Guselkumab	Total
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	Total of all reporting groups
Overall Participants	520	507	1027
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.0 (13.90)	49.0 (14.88)	49.0 (14.39)
Sex: Female, Male (Count of Participants)
Female	182 35%	193 38.1%	375 36.5%
Male	338 65%	314 61.9%	652 63.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	127 24.4%	120 23.7%	247 24.1%
Not Hispanic or Latino	383 73.7%	379 74.8%	762 74.2%
Unknown or Not Reported	10 1.9%	8 1.6%	18 1.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	7 1.3%	6 1.2%	13 1.3%
Asian	31 6%	35 6.9%	66 6.4%
Native Hawaiian or Other Pacific Islander	2 0.4%	2 0.4%	4 0.4%
Black or African American	38 7.3%	29 5.7%	67 6.5%
White	439 84.4%	431 85%	870 84.7%
More than one race	2 0.4%	4 0.8%	6 0.6%
Unknown or Not Reported	1 0.2%	0 0%	1 0.1%
Region of Enrollment (Count of Participants)
Canada	103 19.8%	106 20.9%	209 20.4%
United States	417 80.2%	401 79.1%	818 79.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period and study visit.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	41.3 7.9%	24.9 4.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving PASI 75
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	22.9 4.4%	5.1 1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving PASI 90
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	21.0 4%	7.9 1.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving PASI 100
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	6.7 1.3%	1.4 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

5. Secondary Outcome

Title	Percentage of Participants Achieving PASI 90
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	58.5 11.3%	35.9 7.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

6. Secondary Outcome

Title	Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)
Description	The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	41.9 8.1%	25.2 5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

7. Secondary Outcome

Title	Percentage of Participants Achieving PASI 50
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	27.5 5.3%	9.3 1.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

8. Secondary Outcome

Title	Percentage of Participants Achieving PASI 100
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	29.6 5.7%	13.6 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

9. Secondary Outcome

Title	Percentage of Participants Achieving PASI 100
Description	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

All randomized participants. Participants who did not meet clinical response criteria or have missing data at Week 12 were considered as non-responders for the Non-Responder Imputation (NRI) analysis.

Arm/Group Title	Ixekizumab	Guselkumab
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Measure Participants	520	507
Number (95% Confidence Interval) [percentage of participants]	50.0 9.6%	52.3 10.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ixekizumab, Guselkumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.414
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

Time Frame	Up to 48 Weeks
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title	Ixekizumab		Guselkumab		Ixekizumab Post-Treatment Follow Up		Guselkumab Post-Treatment Follow Up
Arm/Group Description	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.		During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.		Participants who received ixekizumab in the blinded treatment periods entered the post treatment follow up period.		Participants who received guselkumab in the blinded treatment periods entered the post treatment follow up period.
All Cause Mortality
	Ixekizumab		Guselkumab		Ixekizumab Post-Treatment Follow Up		Guselkumab Post-Treatment Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/519 (0%)		0/506 (0%)		0/465 (0%)		0/456 (0%)
Serious Adverse Events
	Ixekizumab		Guselkumab		Ixekizumab Post-Treatment Follow Up		Guselkumab Post-Treatment Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/519 (3.5%)		16/506 (3.2%)		4/465 (0.9%)		4/456 (0.9%)
Cardiac disorders
Acute myocardial infarction	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Angina unstable	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Cardiac failure congestive	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Coronary artery disease	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Myocardial infarction	1/519 (0.2%)	1	2/506 (0.4%)	2	0/465 (0%)	0	0/456 (0%)	0
Ventricular tachycardia	0/519 (0%)	0	0/506 (0%)	0	0/465 (0%)	0	1/456 (0.2%)	1
Gastrointestinal disorders
Ascites	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Colitis ulcerative	0/519 (0%)	0	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Crohn's disease	1/519 (0.2%)	1	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Gastritis	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Pancreatitis acute	1/519 (0.2%)	1	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Salivary gland calculus	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Hepatobiliary disorders
Cholecystitis	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Cholelithiasis	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Immune system disorders
Anaphylactic reaction	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Infections and infestations
Cellulitis	0/519 (0%)	0	2/506 (0.4%)	3	0/465 (0%)	0	0/456 (0%)	0
Complicated appendicitis	0/519 (0%)	0	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Infection	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Pneumonia	0/519 (0%)	0	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Pyelonephritis	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Sepsis	0/519 (0%)	0	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Injury, poisoning and procedural complications
Concussion	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Fall	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Joint dislocation	0/519 (0%)	0	0/506 (0%)	0	0/465 (0%)	0	1/456 (0.2%)	1
Ulna fracture	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Upper limb fracture	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage iv	0/182 (0%)	0	1/193 (0.5%)	1	0/164 (0%)	0	0/170 (0%)	0
Oesophageal adenocarcinoma	0/519 (0%)	0	0/506 (0%)	0	1/465 (0.2%)	1	0/456 (0%)	0
Rhabdomyosarcoma	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Nervous system disorders
Ischaemic stroke	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Myxoedema coma	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Syncope	2/519 (0.4%)	2	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Transient ischaemic attack	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Psychiatric disorders
Major depression	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Suicidal ideation	1/519 (0.2%)	1	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Renal and urinary disorders
Ureterolithiasis	0/519 (0%)	0	0/506 (0%)	0	0/465 (0%)	0	1/456 (0.2%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/337 (0%)	0	0/313 (0%)	0	0/301 (0%)	0	1/286 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Skin and subcutaneous tissue disorders
Angioedema	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Pemphigoid	1/519 (0.2%)	1	0/506 (0%)	0	0/465 (0%)	0	0/456 (0%)	0
Psoriasis	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Vascular disorders
Deep vein thrombosis	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Hypertensive urgency	0/519 (0%)	0	1/506 (0.2%)	1	0/465 (0%)	0	0/456 (0%)	0
Other (Not Including Serious) Adverse Events
	Ixekizumab		Guselkumab		Ixekizumab Post-Treatment Follow Up		Guselkumab Post-Treatment Follow Up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	113/519 (21.8%)		73/506 (14.4%)		11/465 (2.4%)		9/456 (2%)
General disorders
Injection site reaction	49/519 (9.4%)	80	6/506 (1.2%)	9	0/465 (0%)	0	1/456 (0.2%)	2
Infections and infestations
Nasopharyngitis	34/519 (6.6%)	41	27/506 (5.3%)	29	5/465 (1.1%)	5	2/456 (0.4%)	2
Upper respiratory tract infection	40/519 (7.7%)	44	41/506 (8.1%)	50	6/465 (1.3%)	6	6/456 (1.3%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.