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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03090100
Registration number
NCT03090100
Ethics application status
Date submitted
22/03/2017
Date registered
24/03/2017
Date last updated
1/10/2019
Titles & IDs
Public title
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
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Secondary ID [1]
0
0
2016-002995-29
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Secondary ID [2]
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0
CR108278
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Universal Trial Number (UTN)
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Trial acronym
ECLIPSE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo
Treatment: Drugs - Secukinumab
Experimental: Group I: Guselkumab Plus Placebo - Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind.
Active Comparator: Group II: Secukinumab - Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
Treatment: Drugs: Guselkumab
Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
Treatment: Drugs: Placebo
Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
Treatment: Drugs: Secukinumab
Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48
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Assessment method [1]
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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.
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48
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Assessment method [1]
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Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was 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 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. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [1]
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Week 12 and 48
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Secondary outcome [2]
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Percentage of Participants Who Achieved a PASI-90 Response at Week 12
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Assessment method [2]
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0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.
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Timepoint [2]
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0
Week 12
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Secondary outcome [3]
0
0
Percentage of Participants Who Achieved a PASI-75 Response at Week 12
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Assessment method [3]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [3]
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0
Week 12
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Secondary outcome [4]
0
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Percentage of Participants Who Achieved a PASI-100 Response at Week 48
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Assessment method [4]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 100 response was defined as 100% reduction in PASI relative to baseline.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48
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Assessment method [5]
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The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [5]
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Week 48
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Secondary outcome [6]
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Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48
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Assessment method [6]
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The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [6]
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Week 48
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Secondary outcome [7]
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Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48
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Assessment method [7]
0
0
Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was 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 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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
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Timepoint [7]
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0
Week 16 and 48
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Secondary outcome [8]
0
0
Percentage of Participants Who Achieved a PASI-75 Response at Week 16
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Assessment method [8]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [8]
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0
Week 16
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Secondary outcome [9]
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Percentage of Participants Who Achieved a PASI-90 Response at Week 16
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Assessment method [9]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.
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Timepoint [9]
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0
Week 16
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Secondary outcome [10]
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Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48
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Assessment method [10]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.
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Timepoint [10]
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0
Week 24 up to Week 48
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Secondary outcome [11]
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Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16
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Assessment method [11]
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0
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [11]
0
0
Week 16
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Secondary outcome [12]
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Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12
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Assessment method [12]
0
0
The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [12]
0
0
Week 12
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Secondary outcome [13]
0
0
Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12
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Assessment method [13]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [13]
0
0
Week 48
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Secondary outcome [14]
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Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16
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Assessment method [14]
0
0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.
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Timepoint [14]
0
0
Week 48
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Secondary outcome [15]
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Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56
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Assessment method [15]
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0
PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.
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Timepoint [15]
0
0
Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
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Secondary outcome [16]
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Percentage of Participants With IGA Responses Through Week 56
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Assessment method [16]
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The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [16]
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Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56
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Secondary outcome [17]
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Percent Improvement From Baseline in PASI Through Week 56
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Assessment method [17]
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0
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-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.
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Timepoint [17]
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Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56
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Eligibility
Key inclusion criteria
- Have a diagnosis of plaque-type psoriasis (with or without [Psoriatic Arthritis]PsA)
for at least 6 months before the first administration of study drug
- A woman of childbearing potential must have a negative urine pregnancy test at
screening and at Week 0 and agree to urine pregnancy testing before receiving
injections
- Agree not to receive a live virus or live bacterial vaccination during the study, or
within 3 months after the last administration of study drug
- Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or
within 12 months after the last administration of study drug
- Agree to avoid prolonged sun exposure and avoid use of tanning booths or other
ultraviolet light sources during study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled
renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has previously received guselkumab or secukinumab
- Has a history of chronic or recurrent infectious disease, including but not limited to
chronic renal infection, chronic chest infection (example bronchiectasis), recurrent
urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis),
fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin
wounds or ulcers
- Has a history of lymphoproliferative disease, including lymphoma; a history of
monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive
of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
- Is unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access to veins
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/09/2018
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Sample size
Target
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Accrual to date
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Final
1048
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Skin Centre - Benowa
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Recruitment hospital [2]
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Sinclair Dermatology - East Melbourne
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Recruitment hospital [3]
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Fremantle Dermatology - Fremantle
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Recruitment hospital [4]
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Clinical Trials SA Pty Ltd - Hectorville
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Recruitment hospital [5]
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Premier Specialists - Kogarah
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Recruitment hospital [6]
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St George Dermatology & Skin Cancer Centre - Kogarah
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Recruitment hospital [7]
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0
Skin&Cancer Foundation Inc - Melbourne
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Recruitment hospital [8]
0
0
Royal Melbourne Hospital - Parkville
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Recruitment hospital [9]
0
0
Westmead Hospital - Westmead
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Recruitment hospital [10]
0
0
Woden Dermatology - Woden
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Recruitment hospital [11]
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Veracity Clinical Research - Woolloongabba
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Recruitment postcode(s) [1]
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0
4217 - Benowa
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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6160 - Fremantle
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Recruitment postcode(s) [4]
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5073 - Hectorville
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Recruitment postcode(s) [5]
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2217 - Kogarah
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Recruitment postcode(s) [6]
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3053 - Melbourne
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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2145 - Westmead
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Recruitment postcode(s) [9]
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2606 - Woden
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Recruitment postcode(s) [10]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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United States of America
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California
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0
United States of America
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Connecticut
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0
0
United States of America
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0
Florida
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0
0
United States of America
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Georgia
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0
United States of America
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Illinois
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0
0
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Indiana
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0
0
United States of America
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Kentucky
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United States of America
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Maryland
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0
0
United States of America
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Michigan
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0
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Minnesota
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Missouri
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New Jersey
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New Mexico
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United States of America
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North Carolina
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0
0
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Texas
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Washington
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Canada
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Ontario
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Canada
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Ajax
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Canada
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Edmonton
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Canada
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Halifax
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Canada
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Mississauga
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Canada
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Montreal
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Canada
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Quebec
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Canada
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Surrey
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Canada
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Waterloo
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0
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Canada
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Windsor
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Czechia
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Jihlava
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Czechia
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Kutna Hora
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Czechia
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Nachod
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Czechia
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Novy Jicin
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Czechia
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Ostrava- Poruba
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Praha
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Svitavy
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Czechia
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Usti Nad Labem
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Brest
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France
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La Rochelle
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France
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Martigues
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France
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Nantes
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France
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Nice
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France
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Rouen
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France
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Essen
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Germany
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Frankfurt am Main
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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Mahlow
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Germany
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Muenchen
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Germany
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Muenster
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Germany
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Tuebingen
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Germany
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Witten
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Hungary
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Budapest
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Debrecen
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Kaposvar
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Hungary
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Kecskemet
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Hungary
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Miskolc
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Hungary
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Pecs
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Hungary
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Szeged
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Hungary
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Szombathely
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Veszprem
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Poland
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Bialystok
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Lodz
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Poznan
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Swidnik
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Torun
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Warszawa
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Wroclaw
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Spain
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Alcorcon
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Alicante
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Badalona
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Spain
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Barcelona
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Bilbao Vizcaya
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Spain
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Cordoba
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Madrid
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Manises
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Spain
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Pontevedra
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab
for the treatment of participants with moderate to severe plaque-type psoriasis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03090100
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03090100
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