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A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (VOYAGE 2)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Guselkumab 100 mg

Placebo for guselkumab

Adalimumab

Placebo for adalimumab

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Plaque-type psoriasis, Guselkumab, Adalimumab, CNTO 1959, Monoclonal antibody

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis

Exclusion Criteria:

Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participants who have ever received guselkumab or adalimumab
History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20. Starting at Week 28, participants will receive guselkumab 100 mg or placebo through Week 72 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab [two 0.8 milliliter (mL) injections] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind. All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. Placebo for adalimumab (two 0.8 mL injections) at week 0, followed by one 0.8 mL injection at weeks 1, 3, and 5, and q2w through week 23. At week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg or placebo through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.

Participants will receive adalimumab 80 mg (two 40 mg [0.8 mL] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20. Participants will receive guselkumab or placebo starting at week 28 through week 72 depending upon PASI response. All participants will received guselkumab q8w starting at Week 76 through Week 252.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group 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 area was 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

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24

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.

Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response

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. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group 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.

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group 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 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group

The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.

Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group

The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.

Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response

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. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.

Percentage of Participants Who Achieved PASI 90 Response at Week 252

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. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Percentage of Participants Who Achieved PASI 75 Response at Week 252

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 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252

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). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Percentage of Participants With a DLQI Score of 0 or 1 at Week 252

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. The DLQI was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Full Information

NCT ID

NCT02207244

First Posted

July 31, 2014

Last Updated

June 29, 2021

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02207244

Brief Title

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

Acronym

VOYAGE 2

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

November 3, 2014 (Actual)

Primary Completion Date

October 1, 2015 (Actual)

Study Completion Date

July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).

Detailed Description

This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, Plaque-type psoriasis, Guselkumab, Adalimumab, CNTO 1959, Monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

992 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

Arm Title

Group II

Arm Type

Placebo Comparator

Arm Description

Arm Title

Group III

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Guselkumab 100 mg

Other Intervention Name(s)

CNTO 1959

Intervention Description

100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.

Intervention Type

Drug

Intervention Name(s)

Placebo for guselkumab

Intervention Description

Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

HUMIRA®

Intervention Description

80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.

Intervention Type

Drug

Intervention Name(s)

Placebo for adalimumab

Intervention Description

Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24

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 24

Title

Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response

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. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.

Time Frame

Through Week 48

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group

Description

Time Frame

Baseline, Week 16

Title

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16

Description

Time Frame

Week 16

Title

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16

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 16

Title

Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16

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 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.

Time Frame

Week 16

Title

Description

Time Frame

Week 16

Title

Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24

Description

Time Frame

Week 24

Title

Cumulative Maintenance Rate of PASI 90 Response in the Guselkumab Withdrawal Group Compared to the Guselkumab Maintenance Group Through Week 72 to Evaluate Loss of a PASI 90 Response

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. Cumulative maintenance rate was determined for participants who were withdrawn from study medication and who maintained guselkumab every 8 weeks dosing schedule and was defined as percentage of participants who maintained their PASI 90 response through Week 72.

Time Frame

Through Week 72

Title

Percentage of Participants Who Achieved PASI 90 Response at Week 252

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. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Time Frame

Week 252

Title

Percentage of Participants Who Achieved PASI 75 Response at Week 252

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 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Time Frame

Week 252

Title

Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252

Description

Time Frame

Week 252

Title

Percentage of Participants With a DLQI Score of 0 or 1 at Week 252

Description

Time Frame

Week 252

Title

Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252

Description

Time Frame

Week 252

Title

Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252

Description

The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.

Time Frame

Week 252

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline Must be a candidate for either systemic therapy or phototherapy for psoriasis Exclusion Criteria: Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) Participants who have ever received guselkumab or adalimumab History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

Country

United States

City

Bakersfield

State/Province

California

Country

United States

City

Los Angeles

State/Province

California

Country

United States

City

San Diego

State/Province

California

Country

United States

City

Santa Monica

State/Province

California

Country

United States

City

Aurora

State/Province

Colorado

Country

United States

City

Coral Gables

State/Province

Florida

Country

United States

City

Tampa

State/Province

Florida

Country

United States

City

Newnan

State/Province

Georgia

Country

United States

City

Sandy Springs

State/Province

Georgia

Country

United States

City

Chicago

State/Province

Illinois

Country

United States

City

Rolling Meadows

State/Province

Illinois

Country

United States

City

Skokie

State/Province

Illinois

Country

United States

City

Indianapolis

State/Province

Indiana

Country

United States

City

Plainfield

State/Province

Indiana

Country

United States

City

Louisville

State/Province

Kentucky

Country

United States

City

Andover

State/Province

Massachusetts

Country

United States

City

Fort Gratiot

State/Province

Michigan

Country

United States

City

Troy

State/Province

Michigan

Country

United States

City

Saint Louis

State/Province

Missouri

Country

United States

City

Albuquerque

State/Province

New Mexico

Country

United States

City

New York

State/Province

New York

Country

United States

City

Gahanna

State/Province

Ohio

Country

United States

City

Norman

State/Province

Oklahoma

Country

United States

City

Portland

State/Province

Oregon

Country

United States

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

City

Johnston

State/Province

Rhode Island

Country

United States

City

Arlington

State/Province

Texas

Country

United States

City

Houston

State/Province

Texas

Country

United States

City

Salt Lake City

State/Province

Utah

Country

United States

City

Seattle

State/Province

Washington

Country

United States

City

Spokane

State/Province

Washington

Country

United States

City

Benowa

Country

Australia

City

Hectorville

Country

Australia

City

Melbourne

Country

Australia

City

Parkville

Country

Australia

City

Westmead

Country

Australia

City

Woolloongabba

Country

Australia

City

Barrie

State/Province

Ontario

Country

Canada

City

Hamilton

State/Province

Ontario

Country

Canada

City

Mississauga

State/Province

Ontario

Country

Canada

City

Ottawa

State/Province

Ontario

Country

Canada

City

Richmond Hill

State/Province

Ontario

Country

Canada

City

Toronto

State/Province

Ontario

Country

Canada

City

Waterloo

State/Province

Ontario

Country

Canada

City

Windsor

State/Province

Ontario

Country

Canada

City

Jihlava

Country

Czechia

City

Nachod

Country

Czechia

City

Pardubice

Country

Czechia

City

Plzen

Country

Czechia

City

Praha 10

Country

Czechia

City

Praha 5

Country

Czechia

City

Usti nad Labem

Country

Czechia

City

Dresden

Country

Germany

City

Gera

Country

Germany

City

Hamburg

Country

Germany

City

Kiel

Country

Germany

City

Leipzig

Country

Germany

City

Lubeck

Country

Germany

City

Munster

Country

Germany

City

Tübingen

Country

Germany

City

Witten

Country

Germany

City

Busan

Country

Korea, Republic of

City

Daejeon

Country

Korea, Republic of

City

Gwangju

Country

Korea, Republic of

City

Incheon

Country

Korea, Republic of

City

Seongnam

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Suwon

Country

Korea, Republic of

City

Bialystok

Country

Poland

City

Bydgoszcz

Country

Poland

City

Gdansk

Country

Poland

City

Krakow

Country

Poland

City

Lodz

Country

Poland

City

Lublin

Country

Poland

City

Olsztyn

Country

Poland

City

Poznan

Country

Poland

City

Poznań

Country

Poland

City

Torun

Country

Poland

City

Warszawa

Country

Poland

City

Wroclaw

Country

Poland

City

Chelyabinsk

Country

Russian Federation

City

Cherepovets

Country

Russian Federation

City

Moscow

Country

Russian Federation

City

Rostov-on-Don

Country

Russian Federation

City

Ryazan

Country

Russian Federation

City

St-Petersburg

Country

Russian Federation

City

St. Petersburg

Country

Russian Federation

City

Yaroslavl

Country

Russian Federation

City

Badalona

Country

Spain

City

Barcelona

Country

Spain

City

Bilbao Vizcaya

Country

Spain

City

Madrid

Country

Spain

City

Murcia

Country

Spain

City

Pontevedra

Country

Spain

City

Valencia

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

34105767

Citation

Reich K, Gordon KB, Strober BE, Armstrong AW, Miller M, Shen YK, You Y, Han C, Yang YW, Foley P, Griffiths CEM. Five-year maintenance of clinical response and health-related quality of life improvements in patients with moderate-to-severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2. Br J Dermatol. 2021 Dec;185(6):1146-1159. doi: 10.1111/bjd.20568. Epub 2021 Sep 8.

Results Reference

derived

PubMed Identifier

32910434

Citation

Reich K, Armstrong AW, Foley P, Song M, Miller M, Shen YK, You Y, Han C, Gordon KB. Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study. Am J Clin Dermatol. 2020 Dec;21(6):881-890. doi: 10.1007/s40257-020-00555-7.

Results Reference

derived

PubMed Identifier

31207232

Citation

Gordon KB, Armstrong AW, Foley P, Song M, Shen YK, Li S, Munoz-Elias EJ, Branigan P, Liu X, Reich K. Guselkumab Efficacy after Withdrawal Is Associated with Suppression of Serum IL-23-Regulated IL-17 and IL-22 in Psoriasis: VOYAGE 2 Study. J Invest Dermatol. 2019 Dec;139(12):2437-2446.e1. doi: 10.1016/j.jid.2019.05.016. Epub 2019 Jun 15.

Results Reference

derived

PubMed Identifier

30485400

Citation

Reich K, Papp KA, Armstrong AW, Wasfi Y, Li S, Shen YK, Randazzo B, Song M, Kimball AB. Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies. Br J Dermatol. 2019 May;180(5):1039-1049. doi: 10.1111/bjd.17454.

Results Reference

derived

PubMed Identifier

30417277

Citation

Armstrong AW, Reich K, Foley P, Han C, Song M, Shen YK, You Y, Papp KA. Improvement in Patient-Reported Outcomes (Dermatology Life Quality Index and the Psoriasis Symptoms and Signs Diary) with Guselkumab in Moderate-to-Severe Plaque Psoriasis: Results from the Phase III VOYAGE 1 and VOYAGE 2 Studies. Am J Clin Dermatol. 2019 Feb;20(1):155-164. doi: 10.1007/s40257-018-0396-z.

Results Reference

derived

PubMed Identifier

29799960

Citation

Foley P, Gordon K, Griffiths CEM, Wasfi Y, Randazzo B, Song M, Li S, Shen YK, Blauvelt A. Efficacy of Guselkumab Compared With Adalimumab and Placebo for Psoriasis in Specific Body Regions: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Dermatol. 2018 Jun 1;154(6):676-683. doi: 10.1001/jamadermatol.2018.0793.

Results Reference

derived

Learn more about this trial

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment

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