Clinical Trial Results:
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Oral Tablet Formulation of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Summary
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EudraCT number |
2021-005987-23 |
Trial protocol |
FR ES |
Global end of trial date |
11 Apr 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Apr 2024
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First version publication date |
25 Apr 2024
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
77242113PSO2003
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05357755 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
920 Route 202, South Raritan, New Jersey, United States, 08869
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Apr 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Apr 2023
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this trial was to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in subjects with moderate-to-severe plaque psoriasis.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Jun 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 13
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Country: Number of subjects enrolled |
Germany: 12
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Country: Number of subjects enrolled |
Spain: 4
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Country: Number of subjects enrolled |
France: 5
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Country: Number of subjects enrolled |
Poland: 21
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Country: Number of subjects enrolled |
United States: 34
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Worldwide total number of subjects |
89
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EEA total number of subjects |
42
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
84
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 118 subjects were screened, out of which 28 subjects were screen failure. A total of 90 subjects were randomised, out of which 1 subject was inadvertently randomised but never treated. Hence, 89 subjects started the study and received study treatment. | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||
Arm description |
Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received placebo delayed release tablet once daily.
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Arm title
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JNJ-77242113 10 mg QD | ||||||||||||||||||||||||||||
Arm description |
Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-77242113
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-77242113 10 mg delayed release tablet once daily.
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Arm title
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JNJ-77242113 50 mg QD | ||||||||||||||||||||||||||||
Arm description |
Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
JNJ-77242113
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-77242113 50 mg delayed release tablet once daily.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-77242113 10 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-77242113 50 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||
Reporting group title |
JNJ-77242113 10 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||
Reporting group title |
JNJ-77242113 50 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. |
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End point title |
Percentages of Subjects who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index Score (PASI 75) at Week 16 | ||||||||||||||||
End point description |
Percentages of subjects who achieved PASI 75 (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were reported. PASI score: used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: head, trunk, upper and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline: the closest measurement taken prior to or at the time of first study intervention administration date. Full analysis set (FAS): all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Primary
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End point timeframe |
Baseline, Week 16
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Statistical analysis title |
Statistical Analysis 2 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Statistical Analysis 1 | ||||||||||||||||
Comparison groups |
JNJ-77242113 10 mg QD v Placebo
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.002 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | ||||||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. Data included all TEAEs (both serious and non-serious). The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
From baseline (Week 0) up to 4 weeks after last dose of study drug (up to 20 weeks)
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No statistical analyses for this end point |
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End point title |
Change From Baseline in PASI Total Score at Week 16 | ||||||||||||||||
End point description |
Change from baseline in PASI total score at Week 16 was reported. PASI score: used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI scores, the body was divided into 4 regions: head, trunk, upper extremities and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe, 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. Baseline was defined as the closest measurement taken prior to or at the time of first study agent administration date. FAS: all randomised subjects who took at least 1 dose of study intervention. Here, 'N' (number of subjects analysed)= number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16
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Statistical analysis title |
Statistical Analysis 4 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
54
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Statistical Analysis 3 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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Number of subjects included in analysis |
46
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.002 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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End point title |
Number of Subjects With Serious TEAEs | ||||||||||||
End point description |
An AE is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death, is life threatening, require inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. TEAE was defined as any adverse event that occurs at or after the initial administration of study intervention. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
From baseline (Week 0) up to 4 weeks after last dose of study drug (up to 20 weeks)
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No statistical analyses for this end point |
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End point title |
Percentages of Subjects who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI 90) at Week 16 | ||||||||||||||||
End point description |
Percentages of subjects who achieved PASI 90 (>=90% improvement from baseline in PASI) at Week 16 were reported. The PASI score used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of first study intervention administration date. FAS: all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16
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Statistical analysis title |
Statistical Analysis 6 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Statistical Analysis 5 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.007 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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End point title |
Percentages of Subjects who Achieved 100% Improvement From Baseline in PASI Score (PASI 100) at Week 16 | ||||||||||||||||
End point description |
Percentages of subjects who achieved PASI 100 (100% improvement from baseline in PASI) at Week 16 were reported. The PASI score, used for assessing and grading the severity of psoriatic lesions and their response to therapy. To calculate PASI scores, the body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1=slight, 2=moderate, 3=severe and 4=very severe) and extent of involvement from 0 (no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of first study intervention administration date. FAS included all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16
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Statistical analysis title |
Statistical Analysis 8 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
58
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||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.011 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Statistical Analysis 7 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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Number of subjects included in analysis |
55
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.125 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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End point title |
Percentages of Subjects who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | ||||||||||||||||
End point description |
Percentages of subjects who achieved an IGA score of cleared (0) or minimal (1) at Week 16 was reported. The IGA documented the investigator’s assessment of the subject’s psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling. The subject’s psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. The FAS included all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Week 16
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|
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Statistical analysis title |
Statistical Analysis 10 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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||||||||||||||||
Number of subjects included in analysis |
58
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
|||||||||||||||||
Statistical analysis title |
Statistical Analysis 9 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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||||||||||||||||
Number of subjects included in analysis |
55
|
||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||
Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.002 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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End point title |
Percentages of Subjects Who Achieved an IGA Score of Cleared (0) at Week 16 | ||||||||||||||||
End point description |
Percentages of subjects who achieved an IGA score of cleared (0) at Week 16 was reported. The IGA documented the investigator’s assessment of the subject’s psoriasis at a given time point. Overall lesions were graded for induration, erythema, and scaling. The subject’s psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease. The FAS included all randomised subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
|
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End point timeframe |
Week 16
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Statistical analysis title |
Statistical Analysis 12 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.003 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Statistical Analysis 11 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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Number of subjects included in analysis |
55
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
= 0.071 | ||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||
Confidence interval |
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End point title |
Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16 | ||||||||||||||||
End point description |
Percent change from baseline in psoriasis-affected BSA at Week 16 was reported. BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using handprint method where the surface area of the subject’s hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. The FAS included all randomised subjects who took at least 1 dose of study intervention. Here, 'N' (number of subjects analysed) refers to the number of subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 16
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Statistical analysis title |
Statistical Analysis 14 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 50 mg QD
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Number of subjects included in analysis |
54
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Statistical analysis title |
Statistical Analysis 13 | ||||||||||||||||
Comparison groups |
Placebo v JNJ-77242113 10 mg QD
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Number of subjects included in analysis |
46
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
All cause mortality: From screening up to 4 weeks after last dose of study drug (up to Week 24); Serious AEs and non-serious AEs: From baseline (Week 0) up to 4 weeks after last dose of study drug (up to Week 20)
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Adverse event reporting additional description |
The safety analysis set included all randomised subjects who took at least 1 dose of study intervention.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received placebo delayed release tablet orally matching to JNJ-77242113 to maintain the blind once daily (QD) from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-77242113 50 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-77242113 10 mg QD
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Reporting group description |
Subjects with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Subjects were then followed up for safety up to 4 weeks after the last dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |