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

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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Guselkumab 100 mg; Drug: Placebo for guselkumab; Drug: Placebo for adalimumab; Drug: Adalimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 992
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Benowa, Australia
  • Hectorville, Australia
  • Melbourne, Australia
  • Parkville, Australia
  • Westmead, Australia
  • Woolloongabba, Australia
• Canada
  • Ontario
    • Barrie, Ontario, Canada
    • Hamilton, Ontario, Canada
    • Mississauga, Ontario, Canada
    • Ottawa, Ontario, Canada
    • Richmond Hill, Ontario, Canada
    • Toronto, Ontario, Canada
    • Waterloo, Ontario, Canada
    • Windsor, Ontario, Canada
• Czechia
  • Jihlava, Czechia
  • Nachod, Czechia
  • Pardubice, Czechia
  • Plzen, Czechia
  • Praha 10, Czechia
  • Praha 5, Czechia
  • Usti nad Labem, Czechia
• Germany
  • Dresden, Germany
  • Gera, Germany
  • Hamburg, Germany
  • Kiel, Germany
  • Leipzig, Germany
  • Lubeck, Germany
  • Munster, Germany
  • Tübingen, Germany
  • Witten, Germany
• Korea, Republic of
  • Busan, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Incheon, Korea, Republic of
  • Seongnam, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
• Poland
  • Bialystok, Poland
  • Bydgoszcz, Poland
  • Gdansk, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Olsztyn, Poland
  • Poznan, Poland
  • Poznań, Poland
  • Torun, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
• Russian Federation
  • Chelyabinsk, Russian Federation
  • Cherepovets, Russian Federation
  • Moscow, Russian Federation
  • Rostov-on-Don, Russian Federation
  • Ryazan, Russian Federation
  • St-Petersburg, Russian Federation
  • St. Petersburg, Russian Federation
  • Yaroslavl, Russian Federation
• Spain
  • Badalona, Spain
  • Barcelona, Spain
  • Bilbao Vizcaya, Spain
  • Madrid, Spain
  • Murcia, Spain
  • Pontevedra, Spain
  • Valencia, Spain
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Bakersfield, California, United States
    • Los Angeles, California, United States
    • San Diego, California, United States
    • Santa Monica, California, United States
  • Colorado
    • Aurora, Colorado, United States
  • Florida
    • Coral Gables, Florida, United States
    • Tampa, Florida, United States
  • Georgia
    • Newnan, Georgia, United States
    • Sandy Springs, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Rolling Meadows, Illinois, United States
    • Skokie, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
    • Plainfield, Indiana, United States
  • Kentucky
    • Louisville, Kentucky, United States
  • Massachusetts
    • Andover, Massachusetts, United States
  • Michigan
    • Fort Gratiot, Michigan, United States
    • Troy, Michigan, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • New York, New York, United States
  • Ohio
    • Gahanna, Ohio, United States
  • Oklahoma
    • Norman, Oklahoma, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States
  • Rhode Island
    • Johnston, Rhode Island, United States
  • Texas
    • Arlington, Texas, United States
    • Houston, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Washington
    • Seattle, Washington, United States
    • Spokane, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; 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.	Drug: Guselkumab 100 mg; 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.; Other Names: CNTO 1959; Drug: Placebo for guselkumab; 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).; Drug: Placebo for adalimumab; 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).
Placebo Comparator: Group II; 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.	Drug: Guselkumab 100 mg; 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.; Other Names: CNTO 1959; Drug: Placebo for guselkumab; 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).; Drug: Placebo for adalimumab; 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).
Active Comparator: Group III; 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.	Drug: Guselkumab 100 mg; 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.; Other Names: CNTO 1959; Drug: Placebo for guselkumab; 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).; Drug: Adalimumab; 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.; Other Names: HUMIRA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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	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 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.	Week 24
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.	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	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 scores indicate more impact on quality of life of participants.	Baseline, Week 16
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	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 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.	Week 16
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.	Week 16
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.	Week 16
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.	Baseline and Week 16
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	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.	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.	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.	Week 252
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.	Week 252
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.	Week 252
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.	Week 252
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.	Week 252
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.	Week 252

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Psoriasis; Adalimumab; Plaque-type psoriasis; Guselkumab; CNTO 1959
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Immunologic Factors; Adalimumab; Antibodies, Monoclonal
• Other Study ID Numbers: CR105048; CNTO1959PSO3002 (Other Identifier: Janssen Research & Development, LLC); 2014-000720-18 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No