Trial Outcomes & Findings for A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NCT NCT02203032)

NCT ID: NCT02203032

Last Updated: 2017-09-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

872 participants

Primary outcome timeframe

Week 28 through Week 40

Results posted on

2017-09-12

Participant Flow

Study consists of 2 periods: Open label run-in (Period 1) and blinded phase (Period 2). Participants were enrolled in open label run-in period only. Participants completed the open label run-in period entered into blinded phase period.

Participant milestones

Participant milestones
Measure	Ustekinumab (Open Label Run-in) All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to \[\<=\]100 kilogram \[kg\]) or 90 mg (participants weighing \>100 kg) at Weeks 0 and 4. At Week 16, participants with IGA \>=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.	100 mg Guselkumab (Randomized) Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.	Ustekinumab (Nonrandomized Open Label Continuation) Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight \[Week 0\]) at Weeks 16, 28, and 40.
Open Label Run-in (Week 0 to Week 16) STARTED	872	0	0	0
Open Label Run-in (Week 0 to Week 16) Treated	871	0	0	0
Open Label Run-in (Week 0 to Week 16) COMPLETED	853	0	0	0
Open Label Run-in (Week 0 to Week 16) NOT COMPLETED	19	0	0	0
Blinded Phase (Week 16 to Week 44) STARTED	0	135	133	585
Blinded Phase (Week 16 to Week 44) COMPLETED	0	120	107	539
Blinded Phase (Week 16 to Week 44) NOT COMPLETED	0	15	26	46

Reasons for withdrawal

Reasons for withdrawal
Measure	Ustekinumab (Open Label Run-in) All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to \[\<=\]100 kilogram \[kg\]) or 90 mg (participants weighing \>100 kg) at Weeks 0 and 4. At Week 16, participants with IGA \>=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.	100 mg Guselkumab (Randomized) Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.	Ustekinumab (Nonrandomized Open Label Continuation) Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight \[Week 0\]) at Weeks 16, 28, and 40.
Open Label Run-in (Week 0 to Week 16) Adverse Event	2	0	0	0
Open Label Run-in (Week 0 to Week 16) Lack of Efficacy	1	0	0	0
Open Label Run-in (Week 0 to Week 16) Lost to Follow-up	3	0	0	0
Open Label Run-in (Week 0 to Week 16) Withdrawal by Subject	6	0	0	0
Open Label Run-in (Week 0 to Week 16) Protocol Violation	4	0	0	0
Open Label Run-in (Week 0 to Week 16) Other	2	0	0	0
Open Label Run-in (Week 0 to Week 16) Enrolled but not treated	1	0	0	0
Blinded Phase (Week 16 to Week 44) Lost to Follow-up	0	2	3	8
Blinded Phase (Week 16 to Week 44) Withdrawal by Subject	0	8	19	20
Blinded Phase (Week 16 to Week 44) Other	0	4	1	15
Blinded Phase (Week 16 to Week 44) Death	0	0	0	1
Blinded Phase (Week 16 to Week 44) Completed Safety follow-up	0	1	3	2

Baseline Characteristics

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ustekinumab (Open Label Run-in) n=871 Participants All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to \[\<=\]100 kilogram \[kg\]) or 90 mg (participants weighing \>100 kg) at Weeks 0 and 4. At Week 16, participants with IGA \>=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.
Age, Categorical <=18 years	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	814 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants
Age, Continuous	43.1 years STANDARD_DEVIATION 13.21 • n=5 Participants
Sex: Female, Male Female	305 Participants n=5 Participants
Sex: Female, Male Male	566 Participants n=5 Participants
Region of Enrollment Germany	96 participants n=5 Participants
Region of Enrollment Poland	294 participants n=5 Participants
Region of Enrollment Russia	88 participants n=5 Participants
Region of Enrollment Spain	24 participants n=5 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants
Region of Enrollment Canada	61 participants n=5 Participants
Region of Enrollment United States	194 participants n=5 Participants
Region of Enrollment Australia	19 participants n=5 Participants
Region of Enrollment Korea, Republic Of	29 participants n=5 Participants
Region of Enrollment Taiwan, Province Of China	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 28 through Week 40

Population: Randomized population included all enrolled participants with IGA \>=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.

Outcome measures

Outcome measures
Measure	Guselkumab (Randomized) n=135 Participants Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) n=133 Participants Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40	1.5 visits Standard Deviation 1.57	0.7 visits Standard Deviation 1.26

SECONDARY outcome

Timeframe: Week 28 through Week 40

Population: Randomized population included all enrolled participants with IGA \>=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.

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.

Outcome measures

Outcome measures
Measure	Guselkumab (Randomized) n=135 Participants Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) n=133 Participants Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40	2.2 visits Standard Deviation 1.69	1.1 visits Standard Deviation 1.53

SECONDARY outcome

Timeframe: Week 28 through Week 40

Population: Randomized population included all enrolled participants with IGA \>=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.

Outcome measures

Outcome measures
Measure	Guselkumab (Randomized) n=135 Participants Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) n=133 Participants Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40	0.9 visits Standard Deviation 1.34	0.4 visits Standard Deviation 1.06

SECONDARY outcome

Timeframe: Week 28

Population: Randomized population included all enrolled participants with IGA \>=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.

Outcome measures

Outcome measures
Measure	Guselkumab (Randomized) n=135 Participants Participants from open label Run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) n=133 Participants Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.
Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28	31.1 percentage of participants	14.3 percentage of participants

Adverse Events

Ustekinumab (Open Label Run-in)

Serious events: 11 serious events

Other events: 80 other events

Deaths: 0 deaths

100 mg Guselkumab (Randomized)

Serious events: 9 serious events

Other events: 37 other events

Deaths: 0 deaths

Ustekinumab (Randomized)

Serious events: 6 serious events

Other events: 33 other events

Deaths: 0 deaths

Ustekinumab (Nonrandomized Open Label Continuation)

Serious events: 20 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ustekinumab (Open Label Run-in) n=871 participants at risk All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to \[\<=\]100 kilogram \[kg\]) or 90 mg (participants weighing \>100 kg) at Weeks 0 and 4. At Week 16, participants with IGA \>=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w.	100 mg Guselkumab (Randomized) n=135 participants at risk Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40.	Ustekinumab (Randomized) n=133 participants at risk Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44.	Ustekinumab (Nonrandomized Open Label Continuation) n=585 participants at risk Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight \[Week 0\]) at Weeks 16, 28, and 40.
Infections and infestations Nasopharyngitis	5.4% 47/871 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	17.0% 23/135 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	17.3% 23/133 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	5.6% 33/585 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
Infections and infestations Upper Respiratory Tract Infection	3.8% 33/871 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	11.1% 15/135 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	8.3% 11/133 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.	4.6% 27/585 • Up to Week 60 Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.

Additional Information

Senior Director

Janssen Research & Development, LLC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER