ECLIPSE: A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03090100
• Collaborator: (none)
• Enrollment: 1,048
• Locations: 142
• Arms: 2
• Actual Duration (Months): 16.8
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Guselkumab; Drug: Placebo; Drug: Secukinumab	Phase 3

Detailed Description

The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1048 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
• Actual Study Start Date: Apr 27, 2017
• Actual Primary Completion Date: Aug 2, 2018
• Actual Study Completion Date: Sep 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group I: Guselkumab Plus Placebo Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind.	Drug: Guselkumab; Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.; Drug: Placebo; Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
Active Comparator: Group II: Secukinumab Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.	Drug: Secukinumab; Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.; Other Names: Cosentyx

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 [Week 48]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.

Secondary Outcome Measures

1. Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 [Week 12 and 48]

   Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

2. Percentage of Participants Who Achieved a PASI-90 Response at Week 12 [Week 12]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.

3. Percentage of Participants Who Achieved a PASI-75 Response at Week 12 [Week 12]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

4. Percentage of Participants Who Achieved a PASI-100 Response at Week 48 [Week 48]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.

5. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 [Week 48]

   The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

6. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 [Week 48]

   The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

7. Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 [Week 16 and 48]

   Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.

8. Percentage of Participants Who Achieved a PASI-75 Response at Week 16 [Week 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

9. Percentage of Participants Who Achieved a PASI-90 Response at Week 16 [Week 16]

   The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.

10. Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 [Week 24 up to Week 48]

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.

11. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 [Week 16]

    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

12. Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 [Week 12]

    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

13. Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 [Week 48]

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.

14. Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 [Week 48]

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.

15. Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 [Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56]

    PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.

16. Percentage of Participants With IGA Responses Through Week 56 [Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56]

    The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

17. Percent Improvement From Baseline in PASI Through Week 56 [Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56]

    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA) for at least 6 months before the first administration of study drug

• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections

• Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug

• Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

• Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

• Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

• Has previously received guselkumab or secukinumab

• Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

• Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

• Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35233
2	Southern California Permanente Medical Group	Los Angeles	California	United States	90027
3	Dermatology Specialists	Oceanside	California	United States	92056
4	MedDerm Associates	San Diego	California	United States	92103
5	San Luis Dermatology & Laser Clinic, Inc	San Luis Obispo	California	United States	93405
6	Southern California Dermatology	Santa Ana	California	United States	92701
7	Clinical Research Center of Connecticut	Danbury	Connecticut	United States	06810
8	Olympian Clinical Research	Clearwater	Florida	United States	33757
9	Florida Academic Dermatology Centers	Coral Gables	Florida	United States	33134
10	Renstar Medical Research	Ocala	Florida	United States	34470
11	Park Avenue Dermatology	Orange Park	Florida	United States	32073
12	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia	United States	30022
13	Advanced Medical Research	Atlanta	Georgia	United States	30328
14	Marietta Dermatology Clinical Research	Marietta	Georgia	United States	30060
15	Arlington Dermatology	Rolling Meadows	Illinois	United States	60008
16	Northshore Universite Healthsystem	Skokie	Illinois	United States	60077
17	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana	United States	46256
18	Indiana Clinical Trial Center	Plainfield	Indiana	United States	46168
19	Dermatology Specialists	Louisville	Kentucky	United States	40241
20	DermAssociates, PC	Rockville	Maryland	United States	20850
21	Great Lakes Research Group	Bay City	Michigan	United States	48706
22	Henry Ford Medical Center	Detroit	Michigan	United States	49202
23	Hamzavi Dermatology	Fort Gratiot	Michigan	United States	48059
24	Somerset Skin Centre	Troy	Michigan	United States	48084
25	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
26	Central Dermatology	Saint Louis	Missouri	United States	63117
27	Windsor Dermatology	East Windsor	New Jersey	United States	08520-2505
28	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
29	Dermatology Consulting Services, PLLC	High Point	North Carolina	United States	27262
30	Dermatologists of Greater Columbus	Bexley	Ohio	United States	43209
31	The Ohio State University	Gahanna	Ohio	United States	43230
32	Central Sooner Research	Norman	Oklahoma	United States	73071
33	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
34	Oregon Medical Research Center	Portland	Oregon	United States	97223
35	University of Pittsburgh Department of Dermatology	Pittsburgh	Pennsylvania	United States	15213
36	Clinical Partners	Johnston	Rhode Island	United States	02919
37	Austin Dermatology Associates	Austin	Texas	United States	78705
38	Modern Research Associates	Dallas	Texas	United States	75231
39	Menter Dermatology Research Institute	Dallas	Texas	United States	75246-1615
40	Suzanne Bruce and Associates - The Center for Skin Research	Houston	Texas	United States	77056-4132
41	Progressive Clinical Research	San Antonio	Texas	United States	78213
42	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
43	Virginia Clinical Research	Norfolk	Virginia	United States	23322
44	Dermatology Associates of Seattle	Seattle	Washington	United States	98101-1498
45	The Skin Centre	Benowa		Australia	4217
46	Sinclair Dermatology	East Melbourne		Australia	3002
47	Fremantle Dermatology	Fremantle		Australia	6160
48	Clinical Trials SA Pty Ltd	Hectorville		Australia	5073
49	Premier Specialists	Kogarah		Australia	2217
50	St George Dermatology & Skin Cancer Centre	Kogarah		Australia	2217
51	Skin&Cancer Foundation Inc	Melbourne		Australia	3053
52	Royal Melbourne Hospital	Parkville		Australia	3050
53	Westmead Hospital	Westmead		Australia	2145
54	Woden Dermatology	Woden		Australia	2606
55	Veracity Clinical Research	Woolloongabba		Australia	4102
56	Dermatrials Research	Hamilton	Ontario	Canada	L8N 1Y2
57	Guenther Dermatology Research Centre	London	Ontario	Canada	N6A 3H7
58	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
59	Skin Centre for Dermatology	Peterborough	Ontario	Canada	K9J 5K2
60	Toronto Research Centre	Toronto	Ontario	Canada	M3H5Y8
61	CCA Medical Research Corporation	Ajax		Canada	L1S7K8
62	Stratica Medical	Edmonton		Canada	T5K 1X3
63	Eastern Canada Research Associates	Halifax		Canada	B3H 1Z2
64	DermEdge Research	Mississauga		Canada	L5H 1G9
65	Innovaderm Research	Montreal		Canada	H2K4L5
66	Centre Dermatologique	Quebec		Canada	G1V 4X7
67	Dr. Chih-ho Hong Medical	Surrey		Canada	V3R 6A7
68	K. Papp Clinical Research	Waterloo		Canada	N2J 1C4
69	XLR8 Medical Research	Windsor		Canada	N8W 1E6
70	Nemocnice Jihlava	Jihlava		Czechia	586 33
71	Kozni ambulance Kutna Hora, s.r.o.	Kutna Hora		Czechia	248 01
72	DERMAMEDICA s.r.o.	Nachod		Czechia	547 01
73	Nemocnice Novy Jicin a.s.	Novy Jicin		Czechia	741 01
74	Fakultni nemocnice Ostrava	Ostrava- Poruba		Czechia	708 52
75	Fakultni nemocnice Kralovske Vinohrady	Praha		Czechia	775 20
76	Dermatologicka ambulance	Svitavy		Czechia	568 02
77	Masarykova nemocnice v Usti nad Labem	Usti Nad Labem		Czechia
78	CHU Bordeaux - Hopital St Andre	Bordeaux		France	33000
79	ICH Hopital A. Morvan	Brest		France	29200
80	Groupe Hospitalier La Rochelle - Re - Aunis	La Rochelle		France	17019
81	Le Bateau Blanc	Martigues		France	13500
82	CHU Nantes - Hotel Dieu	Nantes		France	44093
83	CHU de Nice Hopital de l Archet	Nice		France	06200
84	Hopital Charles Nicolle	Rouen		France	76031
85	Hopital Larrey CHU de Toulouse	Toulouse		France	31000
86	Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center	Berlin		Germany	10117
87	ISA GmbH	Berlin		Germany	10789
88	Universitatsklinikum Bonn	Bonn		Germany	53105
89	Klinische Forschung Dresden GmbH	Dresden		Germany	01069
90	University Hospital Dresden	Dresden		Germany	01307
91	Universitatsklinikum Essen	Essen		Germany	45122
92	Universitatsklinikum Frankfurt	Frankfurt am Main		Germany	60590
93	Universitaetsklinik Hamburg-Eppendorf	Hamburg		Germany	20246
94	SCIderm GmbH	Hamburg		Germany	20354
95	MensingDerma research GmbH	Hamburg		Germany	22391
96	Universitatsklinikum Schleswig-Holstein - Kiel	Kiel		Germany	24105
97	Universitaetsklinik Luebeck	Luebeck		Germany	23538
98	Hautarztpraxis	Mahlow		Germany	15831
99	Technische Universitaet Muenchen	Muenchen		Germany	80802
100	Universitaetsklinikum Muenster	Muenster		Germany	48149
101	Universitaetsklinik Tuebingen	Tuebingen		Germany	72076
102	Centrovital	Witten		Germany	58453
103	Semmelweis Egyetem	Budapest		Hungary	1085
104	Debreceni Egyetem Klinikai Kozpont	Debrecen		Hungary	4032
105	Somogy Megyei Kaposi Mor Oktatokorhaz	Kaposvar		Hungary	7400
106	Bacs-kiskun Megyei Korhaz	Kecskemet		Hungary	6000
107	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc		Hungary	3529
108	Pecsi Tudomanyegyetem	Pecs		Hungary	7632
109	Szegedi Tudomanyegyetem	Szeged		Hungary	6720
110	Markusovszky Egyetemi Oktatokorhaz	Szombathely		Hungary	9700
111	Medmare Egeszsegugyi Es Szolgaltato Bt.	Veszprem		Hungary	8200
112	NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik	Bialystok		Poland	15-351
113	Specderm Poznańska sp. j.	Bialystok		Poland	15-375
114	Szpital Uniwersytecki nr 1 im. Dr A. Jurasza	Bydgoszcz		Poland	85-094
115	Centrum Kliniczno Badawcze	Elblag		Poland	82-300
116	Copernicus Podmiot Leczniczy Sp. z o.o	Gdansk		Poland	80-298
117	Malopolskie Centrum Medyczne	Krakow		Poland	30-510
118	Centrum Badawcze Wspolczesnej Terapii	Lodz		Poland	90-242
119	Dermed Centrum Medyczne Sp. z o.o	Lodz		Poland	90-265
120	Solumed S.C.	Poznan		Poland	60-529
121	CRC Sp. z o.o.	Poznan		Poland	60-848
122	Lubelskie Centrum Diagnostyczne	Swidnik		Poland	21-040
123	NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm	Torun		Poland	87-100
124	Przychodnia Specjalistyczna High-Med	Warszawa		Poland	01-817
125	Wojskowy Instytut Medyczny	Warszawa		Poland	04-141
126	DermMedica Sp. z o.o.	Wroclaw		Poland	51-318
127	Centrum Medyczne WroMedica	Wroclaw		Poland	51-685
128	Hosp. Univ. Fundacion Alcorcon	Alcorcon		Spain	28922
129	Hosp. Gral. Univ. de Alicante	Alicante		Spain	03010
130	Hosp. Univ. Germans Trias I Pujol	Badalona		Spain	08916
131	Hosp. Univ. de Cruces	Barakaldo		Spain	48903
132	Hosp. Del Mar	Barcelona		Spain	08003
133	Hosp. de La Santa Creu I Sant Pau	Barcelona		Spain	8041
134	Hosp. Univ. de Basurto	Bilbao Vizcaya		Spain	48009
135	Hosp. Reina Sofia	Cordoba		Spain	14004
136	Hosp. Univ. Infanta Leonor	Madrid		Spain	28031
137	Hosp. Univ. 12 de Octubre	Madrid		Spain	28041
138	Hosp. Univ. La Paz	Madrid		Spain	28046
139	Hosp. Univ. de Torrejon	Madrid		Spain	28850
140	Hosp. de Manises	Manises		Spain	46940
141	Hosp. Provincial de Pontevedra	Pontevedra		Spain	36003
142	Hosp. Univ. I Politecni La Fe	Valencia		Spain	046026

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Oct 5, 2017
• Statistical Analysis Plan - Feb 8, 2018

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03090100
• Other Study ID Numbers: CR108278; 2016-002995-29; CNTO1959PSO3009
• First Posted: Mar 24, 2017
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Pre-assignment Detail	Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Period Title: Overall Study
STARTED	534	514
Treated	534	511
COMPLETED	507	466
NOT COMPLETED	27	48

Baseline Characteristics

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg	Total
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.	Total of all reporting groups
Overall Participants	534	514	1048
Age (Count of Participants)
<=18 years	6 1.1%	2 0.4%	8 0.8%
Between 18 and 65 years	474 88.8%	467 90.9%	941 89.8%
>=65 years	54 10.1%	45 8.8%	99 9.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.3 (13.67)	45.3 (13.57)	45.8 (13.63)
Sex: Female, Male (Count of Participants)
Female	169 31.6%	172 33.5%	341 32.5%
Male	365 68.4%	342 66.5%	707 67.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	27 5.1%	36 7%	63 6%
Not Hispanic or Latino	502 94%	472 91.8%	974 92.9%
Unknown or Not Reported	5 0.9%	6 1.2%	11 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.4%	2 0.4%	4 0.4%
Asian	18 3.4%	12 2.3%	30 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	3 0.6%	3 0.3%
Black or African American	5 0.9%	11 2.1%	16 1.5%
White	499 93.4%	480 93.4%	979 93.4%
More than one race	4 0.7%	0 0%	4 0.4%
Unknown or Not Reported	6 1.1%	6 1.2%	12 1.1%
Region of Enrollment (Count of Participants)
AUSTRALIA	35 6.6%	36 7%	71 6.8%
CANADA	81 15.2%	77 15%	158 15.1%
CZECH REPUBLIC	27 5.1%	28 5.4%	55 5.2%
FRANCE	28 5.2%	30 5.8%	58 5.5%
GERMANY	66 12.4%	56 10.9%	122 11.6%
HUNGARY	25 4.7%	20 3.9%	45 4.3%
POLAND	119 22.3%	119 23.2%	238 22.7%
SPAIN	35 6.6%	33 6.4%	68 6.5%
UNITED STATES	118 22.1%	115 22.4%	233 22.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	84.5 15.8%	70.0 13.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority margin of 10%
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	z-test
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	14.2
	Confidence Interval	(2-Sided) 95%; 9.2 to 19.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	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 Who Achieved a PASI-75 Response at Both Week 12 and 48
Description	Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame	Week 12 and 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	84.6 15.8%	80.2 15.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority margin of 10%
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	z-test
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	4.3
	Confidence Interval	(2-Sided) 95%; -0.2 to 8.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments

3. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-90 Response at Week 12
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	69.1 12.9%	76.1 14.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -12.2 to -1.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-75 Response at Week 12
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	89.3 16.7%	91.6 17.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-2.3
	Confidence Interval	(2-Sided) 95%; -6.0 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-100 Response at Week 48
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	58.2 10.9%	48.4 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.7
	Confidence Interval	(2-Sided) 95%; 3.8 to 15.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
Description	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	62.2 11.6%	50.4 9.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	11.6
	Confidence Interval	(2-Sided) 95%; 5.8 to 17.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
Description	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	85.0 15.9%	74.9 14.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.7
	Confidence Interval	(2-Sided) 95%; 4.9 to 14.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
Description	Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time Frame	Week 16 and 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	72.3 13.5%	64.4 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.8
	Confidence Interval	(2-Sided) 95%; 2.3 to 13.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-75 Response at Week 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	92.7 17.4%	92.8 18.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -3.5 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-90 Response at Week 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	78.5 14.7%	79.6 15.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -6.2 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
Time Frame	Week 24 up to Week 48

Outcome Measure Data

Analysis Population Description

FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	71.0 13.3%	61.5 12%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.8
	Confidence Interval	(2-Sided) 95%; 4.2 to 15.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
Description	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	86.7 16.2%	86.6 16.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -4.2 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
Description	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Number [Percentage of participants]	85.6 16%	86.4 16.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guselkumab 100 mg + Placebo, Secukinumab 300 mg
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -5.0 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	477	471
Number [Percentage of participants]	94.8 17.8%	87.5 17%

15. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	419	409
Number [Percentage of participants]	92.1 17.2%	80.9 15.7%

16. Secondary Outcome

Title	Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
Description	PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.
Time Frame	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Week 1: 100% improvement	0 0%	0 0%
Week 1: >=90% improvement	0 0%	0 0%
Week 1: >=75% improvement	2.1 0.4%	1.8 0.4%
Week 1: >=50% improvement	10.7 2%	12.8 2.5%
Week 2: 100% improvement	0.2 0%	0.6 0.1%
Week 2: >=90% improvement	1.1 0.2%	2.7 0.5%
Week 2: >=75% improvement	6.4 1.2%	11.5 2.2%
Week 2: >=50% improvement	30.9 5.8%	42.0 8.2%
Week 3: 100% improvement	1.7 0.3%	1.6 0.3%
Week 3: >=90% improvement	5.6 1%	8.6 1.7%
Week 3: >=75% improvement	19.5 3.7%	28.4 5.5%
Week 3: >=50% improvement	56.4 10.6%	66.9 13%
Week 4: 100% improvement	4.1 0.8%	5.1 1%
Week 4: >=90% improvement	13.1 2.5%	21.8 4.2%
Week 4: >=75% improvement	39.3 7.4%	50.2 9.8%
Week 4: >=50% improvement	73.4 13.7%	85.4 16.6%
Week 8: 100% improvement	20.0 3.7%	27.2 5.3%
Week 8: >=90% improvement	48.7 9.1%	62.1 12.1%
Week 8: >=75% improvement	76.4 14.3%	86.2 16.8%
Week 8: >=50% improvement	95.3 17.8%	96.9 18.9%
Week 12: 100% improvement	37.8 7.1%	42.0 8.2%
Week 12: >=90% improvement	69.1 12.9%	76.1 14.8%
Week 12: >=75% improvement	89.3 16.7%	91.6 17.8%
Week 12: >=50% improvement	96.8 18.1%	96.1 18.7%
Week 16: 100% improvement	47.8 9%	46.1 9%
Week 16: >=90% improvement	78.5 14.7%	79.6 15.5%
Week 16: >=75% improvement	92.7 17.4%	92.8 18.1%
Week 16: >=50% improvement	97.6 18.3%	96.3 18.7%
Week 20: 100% improvement	51.3 9.6%	48.6 9.5%
Week 20: >=90% improvement	80.1 15%	81.1 15.8%
Week 20: >=75% improvement	93.6 17.5%	92.4 18%
Week 20: >=50% improvement	97.6 18.3%	95.1 18.5%
Week 24: 100% improvement	54.7 10.2%	50.4 9.8%
Week 24: >=90% improvement	83.1 15.6%	78.2 15.2%
Week 24: >=75% improvement	94.2 17.6%	90.3 17.6%
Week 24: >=50% improvement	97.8 18.3%	93.0 18.1%
Week 28: 100% improvement	57.1 10.7%	51.0 9.9%
Week 28: >=90% improvement	85.4 16%	77.2 15%
Week 28: >=75% improvement	94.0 17.6%	90.3 17.6%
Week 28: >=50% improvement	97.2 18.2%	93.0 18.1%
Week 32: 100% improvement	57.5 10.8%	50.2 9.8%
Week 32:>=90 % improvement	84.8 15.9%	77.4 15.1%
Week 32: >=75% improvement	94.0 17.6%	89.3 17.4%
Week 32: >=50% improvement	97.0 18.2%	93.0 18.1%
Week 36: 100% improvement	58.6 11%	50.0 9.7%
Week 36: >=90% improvement	84.5 15.8%	75.7 14.7%
Week 36: >=75% improvement	93.6 17.5%	87.0 16.9%
Week 36: >=50% improvement	97.2 18.2%	92.2 17.9%
Week 40: 100% improvement	58.2 10.9%	48.6 9.5%
Week 40: >=90% improvement	84.6 15.8%	73.7 14.3%
Week 40: >=75% improvement	92.9 17.4%	85.8 16.7%
Week 40: >=50% improvement	95.9 18%	90.9 17.7%
Week 44: 100% improvement	58.6 11%	49.4 9.6%
Week 44: >=90% improvement	84.1 15.7%	72.6 14.1%
Week 44: >=75% improvement	92.3 17.3%	85.2 16.6%
Week 44: >=50% improvement	94.2 17.6%	91.4 17.8%
Week 48: 100% improvement	58.2 10.9%	48.4 9.4%
Week 48: >=90% improvement	84.5 15.8%	70.0 13.6%
Week 48: >=75% improvement	92.1 17.2%	83.5 16.2%
Week 48: >=50% improvement	94.0 17.6%	89.3 17.4%
Week 56: 100% improvement	50.4 9.4%	27.0 5.3%
Week 56: >=90% improvement	77.3 14.5%	51.4 10%
Week 56: >=75% improvement	88.0 16.5%	70.4 13.7%
Week 56: >=50% improvement	91.0 17%	82.1 16%

17. Secondary Outcome

Title	Percentage of Participants With IGA Responses Through Week 56
Description	The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Week 1: cleared (0)	0 0%	0 0%
Week 1: cleared (0) or minimal (1)	3.4 0.6%	2.5 0.5%
Week 1: mild or better (=<2)	27.2 5.1%	34.2 6.7%
Week 2: cleared (0)	0.2 0%	0.8 0.2%
Week 2: cleared (0) or minimal (1)	12.4 2.3%	20.2 3.9%
Week 2: mild or better (=<2)	54.1 10.1%	63.8 12.4%
Week 3: cleared (0)	2.6 0.5%	3.3 0.6%
Week 3: cleared (0) or minimal (1)	27.2 5.1%	39.9 7.8%
Week 3: mild or better (=<2)	75.3 14.1%	82.5 16.1%
Week 4: cleared (0)	6.7 1.3%	9.7 1.9%
Week 4: cleared (0) or minimal (1)	44.2 8.3%	59.3 11.5%
Week 4: mild or better (=<2)	85.6 16%	92.2 17.9%
Week 8: cleared (0)	29.2 5.5%	35.8 7%
Week 8: cleared (0) or minimal (1)	76.6 14.3%	83.5 16.2%
Week 8: mild or better (=<2)	96.3 18%	96.3 18.7%
Week 12: cleared (0)	46.3 8.7%	50.2 9.8%
Week 12: cleared (0) or minimal (1)	85.6 16%	86.4 16.8%
Week 12: mild or better (=<2)	96.8 18.1%	95.3 18.5%
Week 16: cleared (0)	55.4 10.4%	53.5 10.4%
Week 16: mild or better (=<2)	96.8 18.1%	94.7 18.4%
Week 16: cleared (0) or minimal (1)	86.7 16.2%	86.6 16.8%
Week 20: cleared (0)	56.9 10.7%	53.9 10.5%
Week 20: cleared (0) or minimal (1)	87.8 16.4%	85.6 16.7%
Week 20: mild or better (=<2)	95.3 17.8%	93.2 18.1%
Week 24: cleared (0)	61.0 11.4%	56.0 10.9%
Week 24: cleared (0) or minimal (1)	88.6 16.6%	82.7 16.1%
Week 24: mild or better (=<2)	96.3 18%	91.6 17.8%
Week 28: cleared (0)	62.2 11.6%	56.2 10.9%
Week 28: cleared (0) or minimal (1)	87.8 16.4%	82.9 16.1%
Week 28: mild or better (<=2)	95.5 17.9%	90.9 17.7%
Week 32: cleared (0)	63.1 11.8%	54.5 10.6%
Week 32: cleared (0) or minimal (1)	88.6 16.6%	81.5 15.9%
Week 32: mild or better (=<2)	95.5 17.9%	90.5 17.6%
Week 36: cleared (0)	60.7 11.4%	53.7 10.4%
Week 36: cleared (0) or minimal (1)	86.5 16.2%	79.6 15.5%
Week 36: mild or better (=<2)	95.5 17.9%	88.9 17.3%
Week 40: cleared (0)	63.1 11.8%	52.3 10.2%
Week 40: cleared (0) or minimal (1)	86.3 16.2%	78.0 15.2%
Week 40: mild or better (=<2)	93.6 17.5%	87.9 17.1%
Week 44: cleared (0)	62.2 11.6%	51.9 10.1%
Week 44: cleared (0) or minimal (1)	86.0 16.1%	76.5 14.9%
Week 44: mild or better (=<2)	92.3 17.3%	87.5 17%
Week 48: cleared (0)	62.2 11.6%	50.4 9.8%
Week 48: cleared (0) or minimal (1)	85.0 15.9%	74.9 14.6%
Week 48: mild or better (=<2)	92.7 17.4%	86.8 16.9%
Week 56: cleared (0)	54.3 10.2%	29.4 5.7%
Week 56: cleared (0) or minimal (1)	78.8 14.8%	58.2 11.3%
Week 56: mild or better (=<2)	87.5 16.4%	76.3 14.8%

18. Secondary Outcome

Title	Percent Improvement From Baseline in PASI Through Week 56
Description	The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame	Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56

Outcome Measure Data

Analysis Population Description

Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied.

Arm/Group Title	Guselkumab 100 mg + Placebo	Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.	Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
Measure Participants	534	514
Week 1	20.30 (20.743)	24.72 (20.711)
Week 2	37.85 (23.567)	44.56 (23.600)
Week 3	52.76 (24.186)	60.57 (21.871)
Week 4	64.63 (22.862)	72.80 (19.478)
Week 8	84.36 (17.278)	89.40 (13.579)
Week 12	90.85 (14.484)	92.60 (13.703)
Week 16	93.65 (12.849)	93.94 (12.123)
Week 20	94.35 (11.525)	94.41 (12.152)
Week 24	95.27 (9.848)	93.75 (14.314)
Week 28	95.58 (9.663)	92.96 (16.835)
Week 32	95.74 (9.336)	92.95 (16.641)
Week 36	95.45 (11.119)	92.40 (17.125)
Week 40	95.78 (10.456)	91.77 (17.733)
Week 44	95.45 (12.293)	91.34 (18.246)
Week 48	95.76 (11.629)	90.87 (19.181)
Week 56	93.35 (16.116)	81.67 (27.627)

Adverse Events

Time Frame	Up to Week 56
Adverse Event Reporting Description	Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Arm/Group Title	Guselkumab 100 mg + Placebo		Secukinumab 300 mg
Arm/Group Description	Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56.		Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56.
All Cause Mortality
	Guselkumab 100 mg + Placebo		Secukinumab 300 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/534 (0%)		0/511 (0%)
Serious Adverse Events
	Guselkumab 100 mg + Placebo		Secukinumab 300 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/534 (6.2%)		37/511 (7.2%)
Cardiac disorders
Atrial Fibrillation	1/534 (0.2%)		1/511 (0.2%)
Atrioventricular Block Complete	0/534 (0%)		1/511 (0.2%)
Cardiac Failure Congestive	0/534 (0%)		1/511 (0.2%)
Coronary Artery Occlusion	1/534 (0.2%)		0/511 (0%)
Wolff-Parkinson-White Syndrome	1/534 (0.2%)		0/511 (0%)
Eye disorders
Macular Fibrosis	1/534 (0.2%)		0/511 (0%)
Gastrointestinal disorders
Constipation	1/534 (0.2%)		0/511 (0%)
Crohn's Disease	0/534 (0%)		1/511 (0.2%)
Haemorrhoids	0/534 (0%)		1/511 (0.2%)
Leukoplakia Oral	1/534 (0.2%)		0/511 (0%)
Umbilical Hernia	1/534 (0.2%)		0/511 (0%)
General disorders
Chest Pain	0/534 (0%)		1/511 (0.2%)
Exercise Tolerance Decreased	0/534 (0%)		1/511 (0.2%)
General Physical Health Deterioration	1/534 (0.2%)		0/511 (0%)
Non-Cardiac Chest Pain	1/534 (0.2%)		1/511 (0.2%)
Hepatobiliary disorders
Cholecystitis	0/534 (0%)		1/511 (0.2%)
Cholecystitis Acute	1/534 (0.2%)		0/511 (0%)
Cholelithiasis	1/534 (0.2%)		1/511 (0.2%)
Drug-Induced Liver Injury	0/534 (0%)		1/511 (0.2%)
Immune system disorders
Anaphylactoid Reaction	0/534 (0%)		1/511 (0.2%)
Infections and infestations
Abscess Limb	0/534 (0%)		1/511 (0.2%)
Appendicitis	1/534 (0.2%)		0/511 (0%)
Cellulitis	1/534 (0.2%)		1/511 (0.2%)
Labyrinthitis	1/534 (0.2%)		0/511 (0%)
Neuroborreliosis	0/534 (0%)		1/511 (0.2%)
Pneumonia	1/534 (0.2%)		1/511 (0.2%)
Pyelonephritis	0/534 (0%)		1/511 (0.2%)
Injury, poisoning and procedural complications
Clavicle Fracture	1/534 (0.2%)		0/511 (0%)
Femoral Neck Fracture	0/534 (0%)		1/511 (0.2%)
Foot Fracture	0/534 (0%)		1/511 (0.2%)
Ligament Rupture	1/534 (0.2%)		0/511 (0%)
Meniscus Injury	1/534 (0.2%)		0/511 (0%)
Skull Fracture	1/534 (0.2%)		0/511 (0%)
Tendon Rupture	0/534 (0%)		1/511 (0.2%)
Upper Limb Fracture	0/534 (0%)		1/511 (0.2%)
Investigations
Electrocardiogram Repolarisation Abnormality	1/534 (0.2%)		0/511 (0%)
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion	0/534 (0%)		2/511 (0.4%)
Osteoarthritis	1/534 (0.2%)		1/511 (0.2%)
Rotator Cuff Syndrome	1/534 (0.2%)		0/511 (0%)
Spinal Column Stenosis	0/534 (0%)		1/511 (0.2%)
Spinal Osteoarthritis	0/534 (0%)		1/511 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma	1/534 (0.2%)		0/511 (0%)
Non-Small Cell Lung Cancer	0/534 (0%)		1/511 (0.2%)
Nervous system disorders
Cerebrovascular Accident	0/534 (0%)		1/511 (0.2%)
Headache	1/534 (0.2%)		0/511 (0%)
Syncope	0/534 (0%)		1/511 (0.2%)
Psychiatric disorders
Anxiety	1/534 (0.2%)		1/511 (0.2%)
Depression	0/534 (0%)		1/511 (0.2%)
Mixed Anxiety and Depressive Disorder	0/534 (0%)		1/511 (0.2%)
Renal and urinary disorders
Acute Kidney Injury	1/534 (0.2%)		1/511 (0.2%)
Nephrolithiasis	0/534 (0%)		1/511 (0.2%)
Reproductive system and breast disorders
Bartholin's Cyst	1/534 (0.2%)		0/511 (0%)
Benign Prostatic Hyperplasia	0/534 (0%)		1/511 (0.2%)
Endometriosis	1/534 (0.2%)		0/511 (0%)
Prostatomegaly	0/534 (0%)		1/511 (0.2%)
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease	1/534 (0.2%)		0/511 (0%)
Nasal Cyst	1/534 (0.2%)		0/511 (0%)
Nasal Polyps	1/534 (0.2%)		0/511 (0%)
Pneumonia Aspiration	1/534 (0.2%)		0/511 (0%)
Pulmonary Embolism	0/534 (0%)		1/511 (0.2%)
Skin and subcutaneous tissue disorders
Chronic Cutaneous Lupus Erythematosus	1/534 (0.2%)		0/511 (0%)
Drug Eruption	1/534 (0.2%)		0/511 (0%)
Psoriasis	0/534 (0%)		1/511 (0.2%)
Rash Morbilliform	1/534 (0.2%)		0/511 (0%)
Surgical and medical procedures
Finger Amputation	0/534 (0%)		1/511 (0.2%)
Vascular disorders
Arteriosclerosis	1/534 (0.2%)		0/511 (0%)
Deep Vein Thrombosis	0/534 (0%)		1/511 (0.2%)
Hypotension	1/534 (0.2%)		0/511 (0%)
Other (Not Including Serious) Adverse Events
	Guselkumab 100 mg + Placebo		Secukinumab 300 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	249/534 (46.6%)		254/511 (49.7%)
Gastrointestinal disorders
Diarrhoea	27/534 (5.1%)		20/511 (3.9%)
Infections and infestations
Nasopharyngitis	118/534 (22.1%)		125/511 (24.5%)
Upper Respiratory Tract Infection	83/534 (15.5%)		92/511 (18%)
Musculoskeletal and connective tissue disorders
Arthralgia	30/534 (5.6%)		25/511 (4.9%)
Back Pain	29/534 (5.4%)		18/511 (3.5%)
Nervous system disorders
Headache	48/534 (9%)		48/511 (9.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.