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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005987-23 | EudraCT Number | ||
| 77242113PSO2003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis.
The population of people living with moderate to severe psoriasis is approximately 3.5 billion who are mostly managed with topical and conventional therapies. JNJ-77242113, investigational drug, targets the immune responses in the body and skin which impacts diseases, such as psoriasis and psoriatic arthritis and this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. The hypothesis of this study is that an oral tablet formulation of JNJ-77242113 will result in superior efficacy compared with placebo as determined by the percentage of participants achieving Psoriasis Area and Severity Index (PASI) 75 (greater than or equal to [>=] 75 percentage [%] improvement in PASI) (PASI 75) response at Week 16. The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week placebo- controlled treatment period, and a follow-up visit approximately 4 weeks after the last administration of study intervention. Safety assessments include adverse events (AEs) monitoring, clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs, physical examinations, concomitant medication monitoring, pregnancy testing, Columbia Suicide Severity Rating Scale (C-SSRS) and tuberculosis evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: JNJ-77242113 Dose 1 | Experimental | Participants will receive JNJ-77242113 Dose 1 as delayed release tablets orally once daily from Week 0 through Week 16. |
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| Group 2: JNJ-77242113 Dose 2 | Experimental | Participants will receive JNJ-77242113 Dose 2 as delayed release tablets orally once daily from Week 0 through Week 16. |
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| Group 3: Placebo | Placebo Comparator | Participants will receive oral dose of matching placebo once daily from Week 0 through Week 16. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-77242113 | Drug | JNJ-77242113 will be administered orally as delayed release tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16 | Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | Baseline (Week 0), Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PASI Total Score at Week 16 | Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoll Dermatology | Beverly Hills | California | 90212 | United States | ||
| Northshore University Healthsystem |
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
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A total of 90 subjects were randomized, out of which 1 subject was inadvertently randomized but never treated. Hence, 89 subjects started the study and received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants 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. Participants were then followed up for safety through Week 20. |
| FG001 | JNJ-77242113 10 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2022 | Mar 19, 2026 |
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| Placebo | Drug | Matching placebo will be administered orally as delayed release tablets. |
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| Baseline (Week 0), Week 16 |
| Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16 | Percentages of participants who achieved PASI 100- score (100% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | Baseline (Week 0), Week 16 |
| Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Week 16 |
| Percentages of Participants Who Achieved an IGA Score of Cleared (0) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | Week 16 |
| Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16 | 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 participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. | Baseline (Week 0), Week 16 |
| Number of Participants With 1 or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant 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 occurred at or after the initial administration of study intervention. Data included all TEAEs (both serious and non-serious). | From Week 0 through Week 20 |
| Number of Participants With Serious TEAEs | An AE is any untoward medical occurrence in a clinical study participant 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. | From Week 0 through Week 20 |
| Skokie |
| Illinois |
| 60077 |
| United States |
| Epiphany Dermatology of Kansas, LLC | Overland Park | Kansas | 66210 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40241 | United States |
| Lawrence J Green MD LLC | Rockville | Maryland | 20850 | United States |
| ActivMed Practices and Research | Beverly | Massachusetts | 01915 | United States |
| ActivMed Practices and Research | Portsmouth | New Hampshire | 03801 | United States |
| Windsor Dermatology, PC | East Windsor | New Jersey | 08520 | United States |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | United States |
| The Pennsylvania Centre for Dermatology, LLC | Exton | Pennsylvania | 19341 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| Dermatology Research Institute Inc | Calgary | Alberta | T2J 7E1 | Canada |
| The Guenther Dermatology Research Centre | London | Ontario | N6A 3H7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| DermEdge Research | Mississauga | Ontario | L4Y 4C5 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H 5Y8 | Canada |
| CHRU Brest - Hopital Morvan | Brest | 29200 | France |
| CHU de Grenoble Hopital Albert Michallon | La Tronche | 38700 | France |
| CHU de Nice Hopital de l Archet | Nice | 06200 | France |
| Polyclinique de Courlancy | Reims | 51100 | France |
| Hautarztpraxis | Bramsche | 49565 | Germany |
| Universitatsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Privatpraxis Dr. Hilton & Partner | Düsseldorf | 40212 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitatsklinikum Schleswig Holstein Campus Lubeck | Lübeck | 23538 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Universitaetsmedizin Rostock | Rostock | 18057 | Germany |
| Specderm Poznanska sp j | Bialystok | 15 375 | Poland |
| Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna | Krakow | 30 002 | Poland |
| Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna | Lodz | 90-338 | Poland |
| Hosp. Univ. de Cruces | Barakaldo | 48902 | Spain |
| Hosp. Univ. San Cecilio | Granada | 18016 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| FG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants 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. Participants were then followed up for safety through Week 20. |
| BG001 | JNJ-77242113 10 mg QD | Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| BG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentages of Participants Who Achieved at Least 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI 75) Score at Week 16 | Percentage of participants who achieved PASI-75 score (greater than or equal to [>=] 75% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | Full analysis set (FAS) included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. | Posted | Number | percentage of participants | Baseline (Week 0), Week 16 |
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| Secondary | Change From Baseline in PASI Total Score at Week 16 | Change from baseline in PASI total score at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. Here, 'N' (number of participants analyzed)= number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 0), Week 16 |
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| Secondary | Percentages of Participants Who Achieved at Least 90% Improvement From Baseline in PASI (PASI 90) Score at Week 16 | Percentage of participants who achieved PASI-90 score (>=90% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. | Posted | Number | percentage of participants | Baseline (Week 0), Week 16 |
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| Secondary | Percentages of Participants Who Achieved 100% Improvement From Baseline in PASI (PASI 100) Score at Week 16 | Percentages of participants who achieved PASI 100- score (100% improvement from baseline in PASI) at Week 16 were reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, 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 (indicated 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 the first study drug administration date. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. | Posted | Number | percentage of participants | Baseline (Week 0), Week 16 |
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| Secondary | Percentage of Participants Who Achieved an Investigator Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentages of Participants Who Achieved an IGA Score of Cleared (0) at Week 16 | The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>)1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percent Change From Baseline in Psoriasis-Affected Body Surface Area (BSA) at Week 16 | 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 participant's hand including the palm and all 5 digits was used as a guide to estimate 1% BSA. The baseline measurement was defined as the closest measurement taken prior to or at the time of the first study intervention administration date. | FAS included all participants who were randomized at Week 0 in the study, excluding the one participant that was inadvertently randomized. Here, 'N' (overall number of participants analysed) refers to the number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 0), Week 16 |
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| Secondary | Number of Participants With 1 or More Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant 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 occurred at or after the initial administration of study intervention. Data included all TEAEs (both serious and non-serious). | Safety analysis set included all randomized participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Week 0 through Week 20 |
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| Secondary | Number of Participants With Serious TEAEs | An AE is any untoward medical occurrence in a clinical study participant 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. | Safety analysis set included all randomized participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Week 0 through Week 20 |
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From Week 0 through Week 20
The safety analysis set included all randomized participants who took at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants 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. Participants were then followed up for safety through Week 20. | 0 | 24 | 0 | 24 | 10 | 24 |
| EG001 | JNJ-77242113 10 mg QD | Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. | 0 | 31 | 0 | 31 | 7 | 31 |
| EG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. | 0 | 34 | 2 | 34 | 11 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radius Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza Like Illness | General disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head Dermatology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2023 | Mar 19, 2026 | SAP_001.pdf |
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| FRANCE |
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| GERMANY |
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| POLAND |
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| SPAIN |
|
| UNITED STATES |
|
| Cochran-Mantel-Haenszel |
| <0.001 |
| Superiority |
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
| JNJ-77242113 10 mg QD |
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
| OG001 |
| JNJ-77242113 10 mg QD |
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
| JNJ-77242113 10 mg QD |
Participants with moderate to severe plaque psoriasis, received 10 milligrams (mg) of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
|
Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
|
| OG002 | JNJ-77242113 50 mg QD | Participants with moderate to severe plaque psoriasis, received 50 mg of JNJ-77242113 delayed release tablet, orally QD from Week 0 through Week 16. Participants were then followed up for safety through Week 20. |
|
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