Back to results

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis (GUIDE)

Primary Purpose

Psoriasis

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Guselkumab

Placebo Injection

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

Has a disease duration of plaque psoriasis of either less than or equal to (<=2) years or (greater than (>2) years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40 percent (%) participants must have a disease duration <=2 years
Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >10 or affected body surface area (BSA) >10%) and additionally a Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0)
Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination
Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug

Exclusion Criteria:

Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066])
Has received any systemic immunosuppressant (for example (e.g.) methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus), or anakinra within 4 weeks of the first administration of study drug
Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline
Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug
Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part 1: Guselkumab

Part 2: Guselkumab q8w and Guselkumab q16w

Part 2: Guselkumab q8w

Part 3: Guselkumab Withdrawal

Arm Description

Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.

Eligible participants from Part 1 will continue to participate in Part 2. Participants (super responder [SRe]) with a Psoriasis Area and Severity Index (PASI) score = 0 at weeks 20 and 28 will be randomized to guselkumab 100 mg every 8 weeks (q8w) (group 2a) or guselkumab 100 mg q16w (group 2b), at weeks 28 to 60. Group 2b will receive placebo injection at weeks 28, 44 and 60 to keep the comparison double blind. Participants losing control of disease (PASI score >5) during study Part 2 (until week 60), will enter the re-treatment arm (group 2d) and receive guselkumab 100mg q8w (at re-treatment week 0), followed by administration at re-treatment-weeks 8 and 16.

Participants (Non SRe) in group 2c with a PASI score greater than (>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.

Participants from groups 2a and 2b with a PASI score <3 at week 68 will be included in Part 3 (group 3a and 3b) and be withdrawn from guselkumab. Study visits will be conducted every 12 weeks until week 220 (follow-up). Participants with fluctuating disease (PASI score greater than or equal to [>=] 3) at week 68 or PASI >5 (participants losing control of disease) at any visit during part 3 after week 68 will get an opportunity to enter the re-treatment-arm (group 3c) in which participants will receive three guselkumab injections of 100 mg q8w.

Outcomes

Primary Outcome Measures

Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68

Percentage of participants who achieved an absolute PASI <3 at Week 68 were reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the body surface area involved, which translates to a numeric score that ranged from 0 (indicated 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) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis.

Secondary Outcome Measures

Time to Improvement From Baseline (Week 0) in PASI Score

Time to improvement from baseline in PASI (PASI 75/90/100 response and absolute PASI score =0) for participants with short disease duration (SDD) (less than or equal to [<=] 2 years) and longer disease duration (LDD) (greater than [>] 2 years) was reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75/90/100 responders were defined as participants with >= 75%, >= 90%, 100% improvement in PASI respectively.

Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 120

Percentage of participants with short (<=2 years) and longer (>2 years) disease duration who achieved an absolute PASI Score of 0, <=1 and less than (<) 3 will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.

Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3)

Percentage of participants who retain disease control (that is, absolute PASI score <3 from week 68 through week 116 for participants with short (<= 2 years) and longer (>2 years) disease duration will be reported. Control of disease was defined as participants with a PASI score <3. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease

Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220

Percentage of participants who achieved PASI 75/90/100 response were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. PASI 75 responders were defined as participants with >= 75% improvement in PASI from baseline. PASI 90 responders were defined as participants with >= 90% improvement in PASI from baseline. PASI 100 responders were defined as participants with 100% improvement in PASI from baseline.

Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal

Time to loss of disease control (absolute PASI score >5) after treatment withdrawal beyond Week 68 up to Week 116 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.

Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28

Percentage of participants with an absolute PASI score = 0 at Weeks 12, 16, 20 and 28 were reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translated to numeric score that ranged from 0 (indicated no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.

Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220

Change from baseline (Week 0) in DLQI score at Weeks 28, 68, 116, 164 and 220 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5

Percentage of participants who achieved a DLQI score 0/1 and <5 will be reported. DLQI was a 10-item instrument questionnaire designed to assess the impact of the disease on a participant's quality of life. Each question was evaluated on a 4-point scale ranged from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.

Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220

Change from baseline in the psoriasis affected BSA (%) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220 will be reported. The percentage of the psoriasis-affected BSA percentage is a system used for assessing the severity of psoriasis. The plaque coverage is estimated using the rule of palm (1 palm of the hand = 1% BSA).

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220

Change from baseline in NAPPA-QOL at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-QOL was a 20-item nail-specific QoL questionnaire covering past week. Signs, stigma and everyday life were rated on a 5-point scale, ranged from 0 (no suffering) to 4 (high suffering). A global score was computed by averaging all items which ranged from 0 (no suffering) to 4 (high suffering). A decrease in NAPPA QoL score indicated improvement.

Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220

Change from baseline in NAPPA-PBI at Weeks 28, 68, 116, 164 and 220 will be reported. The NAPPA was an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-PBI was a 24-item questionnaire to assess participant-defined needs before and participant-rated benefits after treatment. The answers were given on a scale from 0 to 4, and a global score was calculated as follows: Each benefit item was multiplied with the respective importance item, and the product is divided by the sum of all importance items. The results were summed up over all items. The resulting global score ranged from 0 (no benefit) to 4 (highest possible benefit). Higher score indicated more benefit.

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220

Change from baseline in NAPPA-CLIN at Weeks 28, 68, 116 164, and 220 will be reported. The NAPPA is an instrument for assessing clinical and patient-reported outcomes in nail psoriasis. NAPPA-CLIN is an instrument used by the physician to assess the least and the worst involved nail of both hands or both feet with scores ranging from 0 (no involvement) to 16 (worst involvement). A higher score indicated a worst involvement.

Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Change From Baseline (Week 0) in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) at Weeks 28, 68, 116, 164 and 220

Change from baseline (Week 0) in the signs and symptoms aggregate scores of the PSSD at Weeks 28, 68, 116, 164 and 220 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).

Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28

Percentage of participants who achieved a PSSD sign score = 0 at Week 68 in participants with a PSSD sign score >= 1 at Week 28 will be reported. The PSSD was a questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a participant self-administered outcomes instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores each ranging from 0 to 100 were derived: the psoriasis symptom score and the psoriasis sign score. A higher score indicated more severe disease. A change of >= 40 points in PSSD symptom score or sign score, and a >= 3-point change in individual PSSD item scale scores will be defined as clinically meaningful change (response).

Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level

The potential association between trough serum guselkumab concentration and efficacy or serum biomarker level will be analyzed by immunoassays. For the analyses the trough serum guselkumab concentration will be set into relation with the efficacy (e.g. PASI response) or with serum biomarker (e.g. serum IL-17A, IL-17F, IL-22) concentration. Guselkumab and all biomarker concentrations will be measured in the unit of picogram/milliliter (pg/mL). In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score <3 at Week 68

The potential association between trough serum guselkumab levels at weeks 20, 28, 36 and 68 and achieving a PASI score <3 at Week 68 will be analyzed. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.

Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment

Percentage of participants who were re-treated due to loss of disease control (PASI >5) and regain control of disease (PASI <3) 24 Weeks after start of re-treatment will be reported. PASI was a system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to numeric score that ranged from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. PASI produced a numeric score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease.

Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities

Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) were reported.

Full Information

NCT ID

NCT03818035

First Posted

January 11, 2019

Last Updated

October 10, 2023

Sponsor

Janssen-Cilag International NV

1. Study Identification

Unique Protocol Identification Number

NCT03818035

Brief Title

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Acronym

GUIDE

Official Title

A Phase 3b, Randomized, Double-blind, Parallel Group, Multicenter Study to Evaluate Further Therapeutic Strategies With Guselkumab in Patients With Moderate-to-Severe Plaque-Type Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 8, 2019 (Actual)

Primary Completion Date

March 7, 2022 (Actual)

Study Completion Date

July 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen-Cilag International NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).

6. Conditions and Keywords

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

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

880 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Guselkumab

Arm Type

Experimental

Arm Description

Participants in group 1 (Part 1) will receive 100 milligram (mg) guselkumab subcutaneously (SC) at Weeks 0, 4, 12 and 20.

Arm Title

Part 2: Guselkumab q8w and Guselkumab q16w

Arm Type

Experimental

Arm Description

Arm Title

Part 2: Guselkumab q8w

Arm Type

Experimental

Arm Description

Participants (Non SRe) in group 2c with a PASI score greater than (>) 0 at week 20 and/or 28 will continue to receive guselkumab 100 mg q8w until week 60.

Arm Title

Part 3: Guselkumab Withdrawal

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Guselkumab

Other Intervention Name(s)

TREMFYA

Intervention Description

Participants will receive 100 mg guselkumab subcutaneously at Weeks 0, 4, 12 and 20 (group 1), at weeks 28, 36, 44, 52, 60 (group 2a and 2c), and at weeks 36 and 52 (group 2b). Group 2d and 3c are the re-treatment groups and will receive three injections after loss of disease control.

Intervention Type

Drug

Intervention Name(s)

Placebo Injection

Intervention Description

Participants of group 2b will receive matching placebo injection subcutaneously at weeks 28, 44 and 60.

Primary Outcome Measure Information:

Title

Group 2a and Group 2b: Percentage of Participants Who Achieved an Absolute Psoriasis Area and Severity Index (PASI) Score Less Than (<) 3 at Week 68

Description

Time Frame

Week 68

Secondary Outcome Measure Information:

Title

Time to Improvement From Baseline (Week 0) in PASI Score

Description

Time Frame

Group 1: Week 0 up to Week 28; Group 2a, 2b, 2c: Week 28 up to Week 68

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieved an Absolute PASI Score of 0, <=1 and <3 at Weeks 20, 28, 68, 116, 164 and 120

Description

Time Frame

Weeks 20, 28, 68, 116, 164 and 120

Title

Group 3a and Group 3b: Percentage of Participants Who Retain Disease Control (Absolute PASI Score < 3)

Description

Time Frame

Week 68 up to Week 116

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 3a and Group 3b: Percentage of Participants Who Achieve a PASI 75/90/100 Response at Weeks 20, 28, 68, 116, 164, and 220

Description

Time Frame

Weeks 20, 28, 68, 116, 164, and 220

Title

Group 3a and Group 3b: Time to Loss of Disease Control (Absolute PASI Score >5) After Treatment Withdrawal

Description

Time Frame

Week 68 up to Week 220

Title

Group 1: Percentage of Participants With an Absolute PASI Score = 0 at Weeks 12, 16, 20 and 28

Description

Time Frame

Weeks 12, 16, 20 and 28

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Change From Baseline (Week 0) in Dermatology Life Quality Index (DLQI) Score at Weeks 28, 68, 116, 164 and 220

Description

Time Frame

Baseline (Week 0), Weeks 28, 68, 116, 164 and 220

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 3a, Group 3b and Group 3c: Percentage of Participants Who Achieved a DLQI Score 0/1 and <5

Description

Time Frame

Weeks 28, 68, 116, 164 and 220

Title

Groups 1, 2a, 2b, 2c, 2d, 3a, 3b, and 3c: Percent Change From Baseline (Week 0) in Psoriasis- Affected Body Surface Area (BSA) at Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220

Description

Time Frame

Baseline (Week 0), Weeks 12, 28, 52, 68, 80, 104, 116, 140, 164, 188, 212 and 220

Title

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis-Quality of Life (NAPPA-QOL) at Weeks 28, 68, 116, 164 and 220

Description

Time Frame

Baseline (Week 0), 28, 68, 116, 164 and 220

Title

Groups 1, 2a, 2b, 2c, 3a, and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Patient Benefit Index (NAPPA-PBI) at Weeks 28, 68, 116, 164 and 220

Description

Time Frame

Baseline (Week 0), Weeks 28, 68, 116, 164 and 220

Title

Groups 1, 2a, 2b, 2c, 3a and 3b: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis- Clinical (NAPPA-CLIN) at Weeks 28, 68, 116, 164 and 220

Description

Time Frame

Baseline (Week 0), Weeks 28, 68, 116, 164 and 220

Title

Description

Time Frame

Baseline (Week 0), Weeks 28, 68, 116, 164 and 220

Title

Group 2a, Group 2b and Group 2c: Percentage of Participants Who Achieved a PSSD Sign Score = 0 at Week 68 in Participants With a PSSD Sign Score >= 1 at Week 28

Description

Time Frame

Week 68

Title

Group 1, Group 2a, Group 2b and Group 2c: Relationship Between Trough Serum Concentration and Efficacy or Serum Biomarker Level

Description

Time Frame

Up to Week 80

Title

Group 2a and Group 2b: Relationship Between Trough Serum Guselkumab Levels at Weeks 20, 28, 36 and 68 and Achieving PASI Score <3 at Week 68

Description

Time Frame

Weeks 20, 28, 36, 68

Title

Group 2d and Group 3c: Percentage of Participants Who Were Re-Treated Due to Loss of Disease Control (PASI >5) and Regain Control of Disease (PASI <3) 24 Weeks After Start of Re-Treatment

Description

Time Frame

Start of re-treatment up to 24 weeks

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b, and Group 3c: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Description

Time Frame

Up to Week 220

Title

Group 1, Group 2a, Group 2b, Group 2c, Group 2d, Group 3a, Group 3b and Group 3c): Number of Participants With Clinically Significant Laboratory Abnormalities

Description

Number of participants with laboratory abnormalities (hematology, serum chemistry and serology) were reported.

Time Frame

Week 220

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a disease duration of plaque psoriasis of either less than or equal to (<=2) years or (greater than (>2) years calculated from date at which first symptoms [plaque] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration <=2 years Has moderate-to-severe plaque-psoriasis defined by a Psoriasis Area and Severity Index (PASI) score >10 or affected body surface area (BSA) >10%) and additionally a Dermatology Life Quality Index (DLQI) score >10 at baseline (week 0) Have no signs or symptoms suggestive of active tuberculosis (TB) upon medical history and/or physical examination Agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug Agrees not to receive a Bacille Calmette-Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug Exclusion Criteria: Has previously received any therapeutic agent directly targeted to interleukin (IL) -23 (including but not limited to guselkumab, tildrakizumab [MK3222], risankizumab [BI-655066]) Has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug. Tests positive for hepatitis B virus (HBV) infection or who are seropositive for antibodies to hepatitis C virus (HCV), unless they have 2 negative HCV RNA test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative HCV RNA test result at baseline Has received natalizumab, belimumab, or agents that modulate B cells or T cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug Has received any anti - tumor necrosis factor (TNF)-α biologic therapy within 3 months before the first administration of study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen-Cilag International NV Clinical Trial

Organizational Affiliation

Janssen-Cilag International NV

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Prive d'Antony

City

Antony

ZIP/Postal Code

92160

Country

France

Facility Name

Centre Hospitalier d'Auxerre

City

Auxerre

ZIP/Postal Code

89011

Country

France

Facility Name

Polyclinique Reims Bezanne - De Courlancy

City

Bezanne

ZIP/Postal Code

51430

Country

France

Facility Name

Centre Hospitalier Le Mans

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Hôpital Edouard Herriot

City

Lyon Cedex 03

ZIP/Postal Code

69437

Country

France

Facility Name

Le Bateau Blanc

City

Martigues

ZIP/Postal Code

13500

Country

France

Facility Name

CHU Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

CHU de Nice Hopital de l Archet

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

CHU Rouen

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

HIA se Sainte-Anne - Toulon

City

Toulon

ZIP/Postal Code

83041

Country

France

Facility Name

CHU Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Universitätsklinikum Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

DermaManagement Augsburg GmbH

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Klinikum Augsburg

City

Augsburg

ZIP/Postal Code

86179

Country

Germany

Facility Name

Fachklinik Bad Bentheim

City

Bad Bentheim

ZIP/Postal Code

48455

Country

Germany

Facility Name

Hautmedizin Bad Soden

City

Bad Soden am Taunus

ZIP/Postal Code

65812

Country

Germany

Facility Name

Charite CCM, Dermatologie

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Vivantes Klinikum Im Friedrichshain

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Rothhaar Studien GmbH

City

Berlin

ZIP/Postal Code

10783

Country

Germany

Facility Name

ISA - Interdisciplinary Study Association GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Hautarztpraxis

City

Berlin

ZIP/Postal Code

12459

Country

Germany

Facility Name

Hautarztpraxis Dr.Wildfeuer

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Hautarztpraxis

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Praxis 'Haut Pur'

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Klinikum Bielefeld Rosenhoehe

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

Katholisches Klinikum Bochum gGmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Niesmann & Othlinghaus GbR

City

Bochum

ZIP/Postal Code

44793

Country

Germany

Facility Name

MVZ Dermatologisches Zentrum Bonn GmbH

City

Bonn

ZIP/Postal Code

53111

Country

Germany

Facility Name

Universitatsklinikum Bonn

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Hautarztpraxis

City

Borna

ZIP/Postal Code

04552

Country

Germany

Facility Name

Hautarztpraxis

City

Bramsche

ZIP/Postal Code

49565

Country

Germany

Facility Name

Derma Nord

City

Bremen

ZIP/Postal Code

28779

Country

Germany

Facility Name

Rosenpark Research GmbH

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Klinikum Darmstadt GmbH - Hautklinik

City

Darmstadt

ZIP/Postal Code

64297

Country

Germany

Facility Name

Klinische Forschung Dresden GmbH

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Praxis für Dermatologie und Venerologie

City

Dresden

ZIP/Postal Code

01097

Country

Germany

Facility Name

University Hospital Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Pro Derma

City

Duelmen

ZIP/Postal Code

48249

Country

Germany

Facility Name

Privatpraxis Dr. Hilton & Partner

City

Dusseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Universitätsklinikum Düsseldorf

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Universitaetsklinik Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitaetsklinikum Essen

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Universitatsklinikum Frankfurt

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Universitatsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79104

Country

Germany

Facility Name

Derma-Study-Center Friedrichshafen GmbH

City

Friedrichshafen

ZIP/Postal Code

88045

Country

Germany

Facility Name

SRH Waldklinikum Gera GmbH

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Hautarztpraxis Brau/Groß

City

Giessen

ZIP/Postal Code

35390

Country

Germany

Facility Name

Universitätsmedizin Göttingen

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitaetsklinik Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Klinische Forschung Hamburg

City

Hamburg

ZIP/Postal Code

20253

Country

Germany

Facility Name

Dermatologikum Hamburg Gmbh

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

SCIderm GmbH

City

Hamburg

ZIP/Postal Code

20537

Country

Germany

Facility Name

MensingDerma research GmbH

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Die Hautklinik Hanau

City

Hanau

ZIP/Postal Code

63450

Country

Germany

Facility Name

Haut- und Laserzentrum Heidelberg

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

Universitaetsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Hautarztpraxis Offers/Adamini

City

Ibbenbüren

ZIP/Postal Code

49477

Country

Germany

Facility Name

Universitätsklinikum Jena

City

Jena

ZIP/Postal Code

07745

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein - Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

MVZ DermaKiel GmbH

City

Kiel

ZIP/Postal Code

24148

Country

Germany

Facility Name

Universitaetsklinikum Koeln

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Praxis Dr. med. Beate Schwarz - Germany

City

Langenau

ZIP/Postal Code

89129

Country

Germany

Facility Name

Universitätsklinikum Leipzig AÖR

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Hautarztpraxis

City

Lingen

ZIP/Postal Code

49809

Country

Germany

Facility Name

Otto Von Guericke Universität Magdeburg

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Gemeinschaftspraxis Scholz/Sebastian/Schilling

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Hautarztzentrum am MDZ

City

Mainz

ZIP/Postal Code

55128

Country

Germany

Facility Name

Universitaetsmedizin Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitaetsklinikum Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Hautarztpraxis

City

Memmingen

ZIP/Postal Code

87700

Country

Germany

Facility Name

Zentderma BAG Dres. Ostendorf - Bohm - Jo GbR

City

Moenchengladbach

ZIP/Postal Code

41061

Country

Germany

Facility Name

Technische Universitaet Muenchen

City

Muenchen

ZIP/Postal Code

80802

Country

Germany

Facility Name

Universitaetsklinikum Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinikum Oldenburg

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Klinische Forschung Osnabrück

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Hautarztpraxis

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Harzklinikum Dorothea Christiane Erxleben GmbH - Germnay

City

Quedlinburg

ZIP/Postal Code

06484

Country

Germany

Facility Name

Universitaetsklinikum Regensburg

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Hautarztpraxis Mortazawi

City

Remscheid

ZIP/Postal Code

42897

Country

Germany

Facility Name

Klinische Forschung Schwerin GmbH

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Company for Medical Study & Service Selters

City

Selters

ZIP/Postal Code

56242

Country

Germany

Facility Name

Hautarztpraxis Dr. Leitz & Kollegen

City

Stuttgart

ZIP/Postal Code

70178

Country

Germany

Facility Name

Hautarztpraxis am Loewenmarkt

City

Stuttgart

ZIP/Postal Code

70499

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Universitatsklinikum Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Hautarztpraxis Kock

City

Vechta

ZIP/Postal Code

49377

Country

Germany

Facility Name

Centrovital

City

Witten

ZIP/Postal Code

58453

Country

Germany

Facility Name

HELIOS Klinikum Wuppertal GmbH

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

CentroDerm GmbH

City

Wuppertal

ZIP/Postal Code

42287

Country

Germany

Facility Name

Universitätsklinikum Würzburg

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Citations:

PubMed Identifier

34518264

Citation

Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.

Results Reference

derived

Learn more about this trial

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

We'll reach out to this number within 24 hrs

A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis (GUIDE)

Psoriasis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial