A Phase 2 interventional study of JNJ-77242113 in Plaque Psoriasis, sponsored by Janssen Research & Development, LLC. Completed at 60 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate long-term clinical response of JNJ-77242113 treatment in participants with moderate-to-severe plaque psoriasis.
The populations of people living with moderate to severe psoriasis is approximately 3.5 billion which 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 this study evaluates JNJ-77242113 as options of advanced therapies in moderate to severe plaque psoriasis. This is a long-term extension study of JNJ-77242113 in eligible participants who have completed the Week 16 visit of the originating Study 77242113PSO2001. The total duration of this study will be up to 40 weeks which will include a 36-week treatment period, and a 4-week safety follow-up period after the last study intervention administration. Safety will be assessed by adverse events (AEs), clinical safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical examinations.
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Exclusion Criteria:
Participants originally randomized to JNJ-77242113 Dose 1 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 QD from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
Participants originally randomized to JNJ-77242113 Dose 2 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 2 QD from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
Participants originally randomized to JNJ-77242113 Dose 3 QD in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
Participants originally randomized to JNJ-77242113 Dose 1 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 1 BID from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
Participants originally randomized to JNJ-77242113 Dose 3 BID in originating study 77242113PSO2001 will continue to receive JNJ-77242113 Dose 3 BID from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
Participants originally randomized to placebo in originating Study 77242113PSO2001 will receive JNJ-77242113 Dose 3 QD from Week 0 through Week 36 in this study.
Drug: JNJ-77242113
JNJ-77242113 tablet will be administered orally.
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36
Percentage of participants who achieved \>=75% improvement from baseline in PASI score at LTE Week 36 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, 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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36
Percentage of participants who achieved \>=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36
Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, 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 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 on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PASI Total Score at LTE Week 36
Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36
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.
Time frame: At LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36
Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value\*10, where, 0=least severe and 100=most severe. Higher score indicated more severe disease. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Change From Baseline in PSSD Signs Score at LTE Week 36
Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that symptom score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
Time frame: Baseline (Week 0 of originating study 77242113PSO2001), LTE Week 36 (52 weeks from originating study baseline)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.
Time frame: From LTE Week 0 up to LTE Week 40
| Milestone | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Started | 35 | 35 | 39 | 40 | 40 | 38 |
| Completed | 29 | 27 | 33 | 30 | 33 | 35 |
| Not completed | 6 | 8 | 6 | 10 | 7 | 3 |
| Withdrew: Withdrawal by subject | 5 | 4 | 3 | 7 | 4 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 | 2 | 1 | 1 |
| Withdrew: Other | 1 | 2 | 2 | 1 | 2 | 1 |
Percentage of participants who achieved \>=75% improvement from baseline in PASI score at LTE Week 36 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, 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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Greater Than or Equal to (>=) 75 Percent (%) Improvement From Baseline in Psoriasis Area Severity Index Score (PASI-75) at LTE Week 36 | 65.7 | 48.8 | 69.8 | 58.5 | 65.1 | 76.2 |
Percentage of participants who achieved \>=90% improvement from baseline in PASI score at LTE Week 36 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In 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, 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 more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved at Least 90% Improvement From Baseline in PASI Score (PASI-90) at LTE Week 36 | 57.1 | 27.9 | 41.9 | 36.6 | 51.2 | 64.3 |
Percentage of participants who achieved 100% improvement from baseline in PASI score at LTE Week 36 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, 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 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 on a scale of 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved 100% Improvement From Baseline in PASI Score (PASI-100) at LTE Week 36 | 34.3 | 14.0 | 20.9 | 17.1 | 25.6 | 40.5 |
Change from baseline in PASI total score at LTE Week 36 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 first study drug administration date in 77242113PSO2001 study.
| Units on a scale | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Change From Baseline in PASI Total Score at LTE Week 36 | -14.15 ± 8.068 | -13.55 ± 8.232 | -14.45 ± 6.878 | -13.24 ± 8.981 | -15.81 ± 8.908 | -18.46 ± 7.892 |
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.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at LTE Week 36 | 65.7 | 37.2 | 60.5 | 46.3 | 60.5 | 73.8 |
Change from baseline in PSSD symptoms scores at LTE Week 36 was reported. PSSD was a patient-reported outcome (PRO) questionnaire designed to measure severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD: self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value\*10, where, 0=least severe and 100=most severe. Higher score indicated more severe disease. Baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Units on a scale | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Scores at LTE Week 36 | -29.5 ± 25.59 | -30.1 ± 28.09 | -35.2 ± 30.81 | -31.2 ± 28.48 | -29.4 ± 27.41 | -47.7 ± 28.04 |
Change from baseline in PSSD sign scores at LTE Week 36 was reported. PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales were answered. The average value was converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Units on a scale | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Change From Baseline in PSSD Signs Score at LTE Week 36 | -42.8 ± 28.65 | -35.2 ± 29.02 | -39.2 ± 31.64 | -36.6 ± 29.16 | -43.1 ± 26.87 | -53.1 ± 22.03 |
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily symptom score when at least 3 items (\>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that symptom score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved PSSD Symptoms Score Equal (=) 0 at LTE Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Symptoms Score >=1 | 34.3 | 18.6 | 21.4 | 17.1 | 30.2 | 26.2 |
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the daily sign score when at least 3 items (\>=50 percentage of 6 items) on these scales are answered. The average value is converted into 0-100 scoring, such that sign score = average value\*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of first study drug administration date in 77242113PSO2001 study.
| Percentage of participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Percentage of Participants Achieving PSSD Signs Score=0 at Week 36 Among Participants With a Baseline (Week 0 of the Originating Study) Signs Score >=1 | 22.9 | 16.3 | 11.6 | 12.2 | 14.0 | 16.7 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any AE that occurred after receiving the treatment in originating study (77242113PSO2001). TEAEs and TESAEs that occurred during this study are reported.
| Participants | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| TEAEs | 23 | 18 | 19 | 27 | 27 | 19 |
| TESAEs | 1 | 0 | 2 | 3 | 2 | 1 |
Collected over From LTE Week 0 up to LTE Week 40. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Then JNJ-77242113 100 mg QD | 0/35 (0%) | 1/35 (2.9%) | 14/35 (40%) |
| JNJ-77242113 25 mg QD | 0/35 (0%) | 0/35 (0%) | 13/35 (37.1%) |
| JNJ-77242113 50 mg QD | 0/39 (0%) | 2/39 (5.1%) | 15/39 (38.5%) |
| JNJ-77242113 25 mg BID | 0/40 (0%) | 3/40 (7.5%) | 17/40 (42.5%) |
| JNJ-77242113 100 mg QD | 0/40 (0%) | 2/40 (5%) | 20/40 (50%) |
| JNJ-77242113 100 mg BID | 0/38 (0%) | 1/38 (2.6%) | 15/38 (39.5%) |
| Event | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| Cerebrovascular AccidentNervous system disorders | 1/35 | 0/35 | 0/39 | 0/40 | 0/40 | 0/38 |
| Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/35 | 0/35 | 0/39 | 0/40 | 0/40 | 1/38 |
| Coronary Artery DiseaseCardiac disorders | 0/35 | 0/35 | 1/39 | 0/40 | 0/40 | 0/38 |
| Non-Cardiac Chest PainGeneral disorders | 0/35 | 0/35 | 1/39 | 0/40 | 0/40 | 0/38 |
| Foot DeformityMusculoskeletal and connective tissue disorders | 0/35 | 0/35 | 1/39 | 0/40 | 0/40 | 0/38 |
| Ventricular DysfunctionCardiac disorders | 0/35 | 0/35 | 0/39 | 1/40 | 0/40 | 0/38 |
| DiverticulitisInfections and infestations | 0/35 | 0/35 | 0/39 | 0/40 | 1/40 | 0/38 |
| Ligament InjuryInjury, poisoning and procedural complications | 0/35 | 0/35 | 0/39 | 1/40 | 0/40 | 0/38 |
| Intervertebral Disc ProtrusionMusculoskeletal and connective tissue disorders | 0/35 | 0/35 | 0/39 | 0/40 | 1/40 | 0/38 |
| Tonsillar HypertrophyRespiratory, thoracic and mediastinal disorders | 0/35 | 0/35 | 0/39 | 1/40 | 0/40 | 0/38 |
| Event | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID |
|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 9/35 | 3/35 | 7/39 | 6/40 | 11/40 | 5/38 |
| Upper Respiratory Tract InfectionInfections and infestations | 4/35 | 6/35 | 3/39 | 3/40 | 2/40 | 4/38 |
| Covid-19Infections and infestations | 2/35 | 1/35 | 3/39 | 1/40 | 2/40 | 3/38 |
| BronchitisInfections and infestations | 1/35 | 1/35 | 3/39 | 1/40 | 0/40 | 0/38 |
| InfluenzaInfections and infestations | 1/35 | 0/35 | 1/39 | 3/40 | 1/40 | 1/38 |
| HeadacheNervous system disorders | 0/35 | 2/35 | 0/39 | 3/40 | 3/40 | 0/38 |
| Urinary Tract InfectionInfections and infestations | 2/35 | 1/35 | 1/39 | 1/40 | 0/40 | 2/38 |
| Alanine Aminotransferase IncreasedInvestigations | 2/35 | 1/35 | 1/39 | 0/40 | 0/40 | 2/38 |
| Aspartate Aminotransferase IncreasedInvestigations | 1/35 | 1/35 | 1/39 | 0/40 | 0/40 | 2/38 |
| VomitingGastrointestinal disorders | 0/35 | 0/35 | 0/39 | 0/40 | 2/40 | 0/38 |
| Age, Continuous(Years) | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID | Total |
|---|---|---|---|---|---|---|---|
| Mean | 44.3 ± 13.96 | 45.1 ± 12.43 | 44.6 ± 9.51 | 46.1 ± 11.75 | 43.8 ± 14.03 | 41.6 ± 11.71 | 44.2 ± 12.25 |
| Sex: Female, Male(Participants) | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID | Total |
|---|---|---|---|---|---|---|---|
| Female | 15 | 9 | 15 | 11 | 10 | 11 | 71 |
| Male | 20 | 26 | 24 | 29 | 30 | 27 | 156 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 4 | 3 | 3 | 2 | 17 |
| Not Hispanic or Latino | 32 | 32 | 34 | 36 | 37 | 36 | 207 |
| Unknown or Not Reported | 0 | 1 | 1 | 1 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 2 | 1 | 1 | 0 | 4 |
| Asian | 5 | 9 | 9 | 7 | 7 | 8 | 45 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 2 | 0 | 0 | 2 |
| Black or African American | 0 | 0 | 0 | 2 | 0 | 1 | 3 |
| White | 30 | 25 | 27 | 27 | 32 | 28 | 169 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 1 | 0 | 1 | 4 |
| Region of Enrollment(Participants) | Placebo Then JNJ-77242113 100 mg QD | JNJ-77242113 25 mg QD | JNJ-77242113 50 mg QD | JNJ-77242113 25 mg BID | JNJ-77242113 100 mg QD | JNJ-77242113 100 mg BID | Total |
|---|---|---|---|---|---|---|---|
| Canada | 7 | 6 | 4 | 7 | 5 | 5 | 34 |
| France | 0 | 1 | 2 | 1 | 0 | 1 | 5 |
| Germany | 6 | 6 | 5 | 7 | 9 | 5 | 38 |
| Japan | 3 | 2 | 3 | 3 | 4 | 4 | 19 |
| Poland | 6 | 9 | 11 | 9 | 12 | 10 | 57 |
| Korea, South | 1 | 2 | 3 | 1 | 1 | 3 | 11 |
| Spain | 2 | 1 | 1 | 2 | 1 | 1 | 8 |
| Taiwan | 1 | 4 | 3 | 3 | 2 | 0 | 13 |
| United Kingdom | 2 | 0 | 0 | 0 | 0 | 1 | 3 |
| United States | 7 | 4 | 7 | 7 | 6 | 8 | 39 |
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Plan to share: Yes — 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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