NCT02325219

An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

Completed Phase 3 Results posted Last updated 22 May 2020

What this trial tests

Phase 3 trial testing CNTO 1959 50 mg in Psoriasis in 192 participants. Completed in 8 February 2019.

Timeline

19 December 2014

Primary endpoint
2 March 2016

8 February 2019

Quick facts

Lead sponsor	Janssen Pharmaceutical K.K.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	192
Start date	19 December 2014
Primary completion	2 March 2016
Estimated completion	8 February 2019
Sites	27 locations across Japan

Drugs / interventions tested

• CNTO 1959 50 mg — full drug profile →
• CTNO 1959 100 mg — full drug profile →
• Placebo 50 mg
• Placebo 100 mg

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Janssen Pharmaceutical K.K. — full company profile →

Who can join

20 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 Primary · Week 16

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

Group	Value	95% CI
Placebo (CP)	7.8
Guselkumab 50 mg (CP)	92.3
Guselkumab 100 mg (CP)	88.9

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 Primary · 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 percentage (%)-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) t

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	70.8
Guselkumab 100 mg (CP)	69.8

Percentage of Participants Who Achieved PASI 75 Response at Week 16 Secondary · 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 percentage (%)-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) t

Group	Value	95% CI
Placebo (CP)	6.3
Guselkumab 50 mg (CP)	89.2
Guselkumab 100 mg (CP)	84.1

Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Secondary · Baseline and Week 16

The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scor

Group	Value	95% CI
Placebo (CP)	-0.8	± 5.40
Guselkumab 50 mg (CP)	-8.3	± 5.87
Guselkumab 100 mg (CP)	-8.5	± 6.95

Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 2, 4, 8, 12, and 16 Secondary · Weeks 2, 4, 8, 12, and 16

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

Week 2: IGA 0 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	0
Guselkumab 100 mg (CP)	0

Week 2: IGA 0/1 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	3.1
Guselkumab 100 mg (CP)	9.5

Week 2: IGA 0/1/2 responders

Group	Value	95% CI
Placebo (CP)	10.9
Guselkumab 50 mg (CP)	47.7
Guselkumab 100 mg (CP)	46.0

Week 4: IGA 0 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	1.5
Guselkumab 100 mg (CP)	6.3

Week 4: IGA 0/1 responders

Group	Value	95% CI
Placebo (CP)	1.6
Guselkumab 50 mg (CP)	27.7
Guselkumab 100 mg (CP)	25.4

Week 4: IGA 0/1/2 responders

Group	Value	95% CI
Placebo (CP)	20.3
Guselkumab 50 mg (CP)	81.5
Guselkumab 100 mg (CP)	77.8

Week 8: IGA 0 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	16.9
Guselkumab 100 mg (CP)	20.6

Week 8: IGA 0/1 responders

Group	Value	95% CI
Placebo (CP)	1.6
Guselkumab 50 mg (CP)	76.9
Guselkumab 100 mg (CP)	65.1

Percentage of Participants With an IGA Score of Cleared (0), Cleared (0) or Minimal (1), and Cleared (0) or Minimal (1) or Mild (2) at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 Secondary · Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

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

Week 20: IGA 0 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	46.2
Guselkumab 100 mg (CP)	57.1
Placebo to Guselkumab 50 mg (After CP)	3.8
Placebo to Guselkumab 100 mg (After CP)	11.5

Week 20: IGA 0/1 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	89.2
Guselkumab 100 mg (CP)	92.1
Placebo to Guselkumab 50 mg (After CP)	57.7
Placebo to Guselkumab 100 mg (After CP)	46.2

Week 20: IGA 0/1/2 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	96.9
Guselkumab 100 mg (CP)	96.8
Placebo to Guselkumab 50 mg (After CP)	84.6
Placebo to Guselkumab 100 mg (After CP)	88.5

Week 24: IGA 0 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	53.8
Guselkumab 100 mg (CP)	57.1
Placebo to Guselkumab 50 mg (After CP)	15.4
Placebo to Guselkumab 100 mg (After CP)	38.5

Week 24: IGA 0/1 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	90.8
Guselkumab 100 mg (CP)	88.9
Placebo to Guselkumab 50 mg (After CP)	88.5
Placebo to Guselkumab 100 mg (After CP)	80.8

Week 24: IGA 0/1/2 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	98.5
Guselkumab 100 mg (CP)	96.8
Placebo to Guselkumab 50 mg (After CP)	96.2
Placebo to Guselkumab 100 mg (After CP)	100.0

Week 28: IGA 0 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	53.8
Guselkumab 100 mg (CP)	49.2
Placebo to Guselkumab 50 mg (After CP)	50.0
Placebo to Guselkumab 100 mg (After CP)	46.2

Week 28: IGA 0/1 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	90.8
Guselkumab 100 mg (CP)	88.9
Placebo to Guselkumab 50 mg (After CP)	100.0
Placebo to Guselkumab 100 mg (After CP)	88.5

Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 2, 4, 8, 12, and 16 Secondary · Weeks 2, 4, 8, 12, and 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 percentage (%)-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) t

Week 2: PASI 50 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	4.6
Guselkumab 100 mg (CP)	17.5

Week 2: PASI 75 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	0
Guselkumab 100 mg (CP)	1.6

Week 2: PASI 90 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	0
Guselkumab 100 mg (CP)	0

Week 2: PASI 100 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	0
Guselkumab 100 mg (CP)	0

Week 4: PASI 50 responders

Group	Value	95% CI
Placebo (CP)	1.6
Guselkumab 50 mg (CP)	49.2
Guselkumab 100 mg (CP)	49.2

Week 4: PASI 75 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	15.4
Guselkumab 100 mg (CP)	17.5

Week 4: PASI 90 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	4.6
Guselkumab 100 mg (CP)	4.8

Week 4: PASI 100 responders

Group	Value	95% CI
Placebo (CP)	0
Guselkumab 50 mg (CP)	1.5
Guselkumab 100 mg (CP)	1.6

Percentage of Participants Who Achieved PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52 Secondary · Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

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 percentage (%)-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) t

Week 20: PASI 50 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	95.4
Guselkumab 100 mg (CP)	96.8
Placebo to Guselkumab 50 mg (After CP)	57.7
Placebo to Guselkumab 100 mg (After CP)	65.4

Week 20: PASI 75 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	90.8
Guselkumab 100 mg (CP)	88.9
Placebo to Guselkumab 50 mg (After CP)	46.2
Placebo to Guselkumab 100 mg (After CP)	30.8

Week 20: PASI 90 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	70.8
Guselkumab 100 mg (CP)	71.4
Placebo to Guselkumab 50 mg (After CP)	19.2
Placebo to Guselkumab 100 mg (After CP)	15.4

Week 20: PASI 100 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	33.8
Guselkumab 100 mg (CP)	34.9
Placebo to Guselkumab 50 mg (After CP)	3.8
Placebo to Guselkumab 100 mg (After CP)	0

Week 24: PASI 50 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	98.5
Guselkumab 100 mg (CP)	98.4
Placebo to Guselkumab 50 mg (After CP)	92.3
Placebo to Guselkumab 100 mg (After CP)	84.6

Week 24: PASI 75 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	90.8
Guselkumab 100 mg (CP)	90.5
Placebo to Guselkumab 50 mg (After CP)	80.8
Placebo to Guselkumab 100 mg (After CP)	61.5

Week 24: PASI 90 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	78.5
Guselkumab 100 mg (CP)	76.2
Placebo to Guselkumab 50 mg (After CP)	42.3
Placebo to Guselkumab 100 mg (After CP)	46.2

Week 24: PASI 100 responders

Group	Value	95% CI
Guselkumab 50 mg (CP)	41.5
Guselkumab 100 mg (CP)	44.4
Placebo to Guselkumab 50 mg (After CP)	11.5
Placebo to Guselkumab 100 mg (After CP)	23.1

Percent Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 Secondary · Baseline and Weeks 2, 4, 8, 12, 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% to 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 can range from 0 (no psoriasis) to 72. A high

Week 2

Group	Value	95% CI
Placebo (CP)	0.4	± 18.55
Guselkumab 50 mg (CP)	20.1	± 20.85
Guselkumab 100 mg (CP)	23.6	± 23.76

Week 4

Group	Value	95% CI
Placebo (CP)	0.0	± 27.74
Guselkumab 50 mg (CP)	45.3	± 26.72
Guselkumab 100 mg (CP)	44.9	± 30.80

Week 8

Group	Value	95% CI
Placebo (CP)	1.5	± 32.73
Guselkumab 50 mg (CP)	74.5	± 22.39
Guselkumab 100 mg (CP)	70.3	± 25.42

Week 12

Group	Value	95% CI
Placebo (CP)	0.5	± 38.28
Guselkumab 50 mg (CP)	83.7	± 20.00
Guselkumab 100 mg (CP)	82.9	± 18.56

Week 16

Group	Value	95% CI
Placebo (CP)	0.2	± 45.53
Guselkumab 50 mg (CP)	88.9	± 17.34
Guselkumab 100 mg (CP)	88.7	± 17.77

Percent Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52 Secondary · Baseline and Weeks 20, 24, 28, 22, 36, 40, 44, 48, and 52

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% to 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 can range from 0 (no psoriasis) to 72. A high

Week 20

Group	Value	95% CI
Guselkumab 50 mg (CP)	89.4	± 18.21
Guselkumab 100 mg (CP)	90.6	± 16.45
Placebo to Guselkumab 50 mg (After CP)	58.7	± 33.67
Placebo to Guselkumab 100 mg (After CP)	51.9	± 39.06

Week 24

Group	Value	95% CI
Guselkumab 50 mg (CP)	91.6	± 14.59
Guselkumab 100 mg (CP)	92.1	± 15.51
Placebo to Guselkumab 50 mg (After CP)	80.7	± 24.87
Placebo to Guselkumab 100 mg (After CP)	78.8	± 22.44

Week 28

Group	Value	95% CI
Guselkumab 50 mg (CP)	91.9	± 14.05
Guselkumab 100 mg (CP)	91.4	± 16.24
Placebo to Guselkumab 50 mg (After CP)	91.6	± 10.81
Placebo to Guselkumab 100 mg (After CP)	85.6	± 20.60

Week 32

Group	Value	95% CI
Guselkumab 50 mg (CP)	92.5	± 12.38
Guselkumab 100 mg (CP)	92.0	± 15.78
Placebo to Guselkumab 50 mg (After CP)	93.1	± 8.59
Placebo to Guselkumab 100 mg (After CP)	89.1	± 19.66

Week 36

Group	Value	95% CI
Guselkumab 50 mg (CP)	92.2	± 13.42
Guselkumab 100 mg (CP)	90.5	± 19.40
Placebo to Guselkumab 50 mg (After CP)	94.7	± 6.76
Placebo to Guselkumab 100 mg (After CP)	91.5	± 13.84

Week 40

Group	Value	95% CI
Guselkumab 50 mg (CP)	92.3	± 13.86
Guselkumab 100 mg (CP)	92.1	± 15.86
Placebo to Guselkumab 50 mg (After CP)	96.4	± 3.87
Placebo to Guselkumab 100 mg (After CP)	92.3	± 14.08

Week 44

Group	Value	95% CI
Guselkumab 50 mg (CP)	91.8	± 17.30
Guselkumab 100 mg (CP)	91.1	± 17.26
Placebo to Guselkumab 50 mg (After CP)	96.6	± 4.39
Placebo to Guselkumab 100 mg (After CP)	92.2	± 14.28

Week 48

Group	Value	95% CI
Guselkumab 50 mg (CP)	91.5	± 17.28
Guselkumab 100 mg (CP)	92.1	± 16.14
Placebo to Guselkumab 50 mg (After CP)	97.9	± 2.73
Placebo to Guselkumab 100 mg (After CP)	91.8	± 14.21

Change From Baseline in the PASI Total Score at Weeks 2, 4, 8, 12, 16 Secondary · Baseline and Weeks 2, 4, 8, 12, 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% to 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 can range from 0 (no psoriasis) to 72. A high

Week 2

Group	Value	95% CI
Placebo (CP)	0.0	± 4.44
Guselkumab 50 mg (CP)	-5.7	± 7.13
Guselkumab 100 mg (CP)	-6.3	± 7.17

Week 4

Group	Value	95% CI
Placebo (CP)	-0.2	± 7.13
Guselkumab 50 mg (CP)	-12.1	± 10.55
Guselkumab 100 mg (CP)	-12.5	± 11.00

Week 8

Group	Value	95% CI
Placebo (CP)	-1.0	± 8.99
Guselkumab 50 mg (CP)	-19.1	± 10.62
Guselkumab 100 mg (CP)	-19.2	± 11.80

Week 12

Group	Value	95% CI
Placebo (CP)	-0.6	± 10.62
Guselkumab 50 mg (CP)	-21.4	± 11.11
Guselkumab 100 mg (CP)	-22.4	± 11.86

Week 16

Group	Value	95% CI
Placebo (CP)	-0.5	± 12.39
Guselkumab 50 mg (CP)	-22.6	± 11.00
Guselkumab 100 mg (CP)	-23.9	± 12.27

Change From Baseline in the PASI Total Score at Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52 Secondary · Baseline and Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52

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% to 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 can range from 0 (no psoriasis) to 72. A high

Week 20

Group	Value	95% CI
Guselkumab 50 mg (CP)	-22.8	± 11.23
Guselkumab 100 mg (CP)	-24.3	± 12.52
Placebo to Guselkumab 50 mg (After CP)	-18.3	± 15.46
Placebo to Guselkumab 100 mg (After CP)	-11.3	± 10.33

Week 24

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.4	± 11.16
Guselkumab 100 mg (CP)	-24.7	± 12.35
Placebo to Guselkumab 50 mg (After CP)	-24.2	± 15.12
Placebo to Guselkumab 100 mg (After CP)	-18.2	± 9.56

Week 28

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.6	± 11.44
Guselkumab 100 mg (CP)	-24.5	± 12.56
Placebo to Guselkumab 50 mg (After CP)	-27.0	± 14.84
Placebo to Guselkumab 100 mg (After CP)	-20.1	± 10.52

Week 32

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.7	± 11.30
Guselkumab 100 mg (CP)	-24.7	± 12.58
Placebo to Guselkumab 50 mg (After CP)	-27.6	± 15.02
Placebo to Guselkumab 100 mg (After CP)	-21.0	± 11.05

Week 36

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.6	± 11.38
Guselkumab 100 mg (CP)	-24.3	± 12.72
Placebo to Guselkumab 50 mg (After CP)	-28.0	± 15.02
Placebo to Guselkumab 100 mg (After CP)	-21.5	± 10.37

Week 40

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.7	± 11.51
Guselkumab 100 mg (CP)	-24.6	± 12.29
Placebo to Guselkumab 50 mg (After CP)	-28.4	± 14.96
Placebo to Guselkumab 100 mg (After CP)	-21.7	± 10.65

Week 44

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.5	± 11.69
Guselkumab 100 mg (CP)	-24.3	± 12.29
Placebo to Guselkumab 50 mg (After CP)	-28.5	± 15.04
Placebo to Guselkumab 100 mg (After CP)	-21.6	± 10.55

Week 48

Group	Value	95% CI
Guselkumab 50 mg (CP)	-23.4	± 11.59
Guselkumab 100 mg (CP)	-24.6	± 12.27
Placebo to Guselkumab 50 mg (After CP)	-28.7	± 14.90
Placebo to Guselkumab 100 mg (After CP)	-21.6	± 10.78

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 52. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (CP)

Serious: 2/64 (3%)

Deaths: —

Guselkumab 50 mg (CP)

Serious: 1/65 (2%)

Deaths: —

Guselkumab 100 mg (CP)

Serious: 1/63 (2%)

Deaths: —

Guselkumab 50 mg (After CP)

Serious: 6/63 (10%)

Deaths: —

Guselkumab 100 mg (After CP)

Serious: 6/62 (10%)

Deaths: —

Placebo to Guselkumab 50 mg (After CP)

Serious: 4/26 (15%)

Deaths: —

Placebo to Guselkumab 100 mg (After CP)

Serious: 5/26 (19%)

Deaths: —

Serious adverse events (35 terms)

Reaction	System	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Guselkumab 50 mg (After CP)	Guselkumab 100 mg (After CP)	Placebo to Guselkumab 50 m…	Placebo to Guselkumab 100 …
Angina Pectoris	Cardiac disorders	—	—	—	—	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—
Cardiac Failure Congestive	Cardiac disorders	—	—	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—	—	—
Diabetic Retinopathy	Eye disorders	—	—	—	—	—	—	—
Glaucoma	Eye disorders	—	—	—	—	—	—	—
Macular Hole	Eye disorders	—	—	—	—	—	—	—
Rhegmatogenous Retinal Detachment	Eye disorders	—	—	—	—	—	—	—
Vitreous Haemorrhage	Eye disorders	—	—	—	—	—	—	—
Gastric Perforation	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—
Inguinal Hernia	Gastrointestinal disorders	—	—	—	—	—	—	—
Large Intestine Polyp	Gastrointestinal disorders	—	—	—	—	—	—	—
Cholecystitis Acute	Hepatobiliary disorders	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—
Bacterial Prostatitis	Infections and infestations	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—
Pancreatic Abscess	Infections and infestations	—	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—	—
Wrist Fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Gouty Tophus	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—

Other adverse events (166 terms — click to expand)

Reaction	System	Placebo (CP)	Guselkumab 50 mg (CP)	Guselkumab 100 mg (CP)	Guselkumab 50 mg (After CP)	Guselkumab 100 mg (After CP)	Placebo to Guselkumab 50 m…	Placebo to Guselkumab 100 …
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—
Psoriasis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Injection Site Erythema	General disorders	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—
Dental Caries	Gastrointestinal disorders	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—
Diabetes Mellitus	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—
Tinea Pedis	Infections and infestations	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Dermatitis Contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Abdominal Pain Upper	Gastrointestinal disorders	—	—	—	—	—	—	—
Injection Site Pruritus	General disorders	—	—	—	—	—	—	—
Hepatic Function Abnormal	Hepatobiliary disorders	—	—	—	—	—	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Injection Site Induration	General disorders	—	—	—	—	—	—	—
Injection Site Pain	General disorders	—	—	—	—	—	—	—
Injection Site Swelling	General disorders	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—
Seasonal Allergy	Immune system disorders	—	—	—	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—	—	—	—
Hordeolum	Infections and infestations	—	—	—	—	—	—	—
Skin Abrasion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—
Dyslipidaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hyperlipidaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Periarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—

Most-reported serious reactions: Angina Pectoris, Atrial Fibrillation, Cardiac Failure Congestive, Cataract, Diabetic Retinopathy, Glaucoma, Macular Hole, Rhegmatogenous Retinal Detachment.

Data from ClinicalTrials.gov NCT02325219 adverse events section.

Sponsor's own description

The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Do G, et al · · 2017 · cited 106× · PMID 29271481 · DOI 10.1002/14651858.cd011535.pub2
2. Interleukin 23 in the skin: role in psoriasis pathogenesis and selective interleukin 23 blockade as treatment.
   Chan TC, Hawkes JE, Krueger JG. · · 2018 · cited 103× · PMID 29796240 · DOI 10.1177/2040622318759282
3. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2022 · cited 84× · PMID 35603936 · DOI 10.1002/14651858.cd011535.pub5
4. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Afach S, Doney L, et al · · 2020 · cited 78× · PMID 31917873 · DOI 10.1002/14651858.cd011535.pub3
5. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study.
   Ohtsuki M, Kubo H, Morishima H, Goto R, et al · · 2018 · cited 77× · PMID 29905383 · DOI 10.1111/1346-8138.14504
6. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Guelimi R, Garcia-Doval I, et al · · 2023 · cited 67× · PMID 37436070 · DOI 10.1002/14651858.cd011535.pub6
7. Safety of selective IL-23p19 inhibitors for the treatment of psoriasis.
   Crowley JJ, Warren RB, Cather JC. · · 2019 · cited 58× · PMID 31054215 · DOI 10.1111/jdv.15653
8. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
   Sbidian E, Chaimani A, Garcia-Doval I, Doney L, et al · · 2021 · cited 54× · PMID 33871055 · DOI 10.1002/14651858.cd011535.pub4