Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Janssen Research & Development, LLC78 enrolled

Overview

The purpose of the study is to evaluate the efficacy, safety, pharmacokinetics, immunogenicity, usability, and acceptability of guselkumab delivered using SelfDose device in participants with moderate to severe plaque-type psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

GuselkumabDRUG

Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.

PlaceboDRUG

Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A woman of childbearing potential must have a negative urine pregnancy test (beta-human chorionic gonadotropin) at screening and at Week 0 * Before randomization, a woman must be either: a) Not of childbearing potential: premenarchal; postmenopausal (greater than \[\>\] 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle-stimulating hormone level (FSH) \>40 International Units Per Liter \[IU/L\]); permanently sterile (example, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, b) Of childbearing potential and practicing a highly effective method of birth control, consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: example, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal foam/gel/ film/cream/suppository (if available in their locale); male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) * Agree not to receive a Bacillus Calmette Guerin (BCG) vaccination during the study, or within 12 months after the last administration of study drug * Have a Psoriasis Area and Severity Index (PASI) greater than or equal to \[\>=\] 12 at screening and at baseline * Have an involved body surface area (BSA) \>= 10 percent (%) at screening and at baseline Exclusion Criteria: * Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months * Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly * Has a transplanted organ (with exception of a corneal transplant \>3 months before the first administration of study drug) * Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) * Has received any anti-tumor necrosis factor alpha (TNF-alpha) biologic therapy within 3 months before the first administration of study drug

Locations (14)

Renstar Medical Research

Ocala, Florida, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Indiana Clinical Trial Center

Plainfield, Indiana, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.

Time frame: Week 16

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.

Time frame: Week 16

Secondary Outcomes

Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16

Data from ClinicalTrials.gov

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Dermatology Specialists

Louisville, Kentucky, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

University of Pittsburgh Department of Dermatology

Pittsburgh, Pennsylvania, United States

Clinical Partners

Johnston, Rhode Island, United States

Virginia Clinical Research

Norfolk, Virginia, United States

Dr. Chih ho Hong Medical

Surrey, British Columbia, Canada

Dermatrials Research

Hamilton, Ontario, Canada

...and 4 more locations

Percentage of Participants Who Achieve a PASI 100 Response at Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.

Time frame: Week 16

Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16

Time frame: Week 16

Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with \>=50% and \>= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.

Time frame: Week 16

Percent Improvement From Baseline in PASI Score at Week 16

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.

Time frame: Baseline and Week 16

Percent Improvement From Baseline in PASI Score Through Week 40

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.

Time frame: Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)

Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40

The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.

Time frame: Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)

Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses

PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with \>=50%, \>= 75%, \>=90% and \>= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.

Time frame: Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)