A Long-term Extension Study of JNJ-77242113 in Participants With Moderate-to-Severe Plaque Psoriasis

Janssen Research & Development, LLC227 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

227

Conditions

Plaque Psoriasis

Interventions

JNJ-77242113DRUG

JNJ-77242113 tablet will be administered orally.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have completed the Week 16 visit in Protocol 77242113PSO2001 * In the opinion of the investigator, may benefit from inclusion in this long term extension (LTE) study * Must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study * Must agree to discontinue all topical therapies that could affect psoriasis or the psoriasis area severity index (PASI) or investigator's global assessment (IGA) evaluation, other than nonmedicated emollient and salicylic acid shampoos, prior to first administration of study intervention * Agree not to receive a live virus or live bacterial vaccination during the study, or within 4 weeks after the last administration of study intervention Exclusion Criteria: * Was permanently discontinued from study intervention in Protocol 77242113PSO2001 for any reason * Has received any biologic therapy or experimental therapy since completion of the originating study, 77242113PSO2001 * Has received any live virus or bacterial vaccination within 12 weeks before the first administration of study intervention * Has received the bacille Calmette-Guerin (BCG) vaccine within 12 months of the first administration of study intervention * Currently has hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or has other clinically active liver disease, or tests positive for HBsAg or anti-HCV

Locations (60)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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Fort Gratiot, Michigan, United States

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East Windsor, New Jersey, United States

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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