Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis

Moderate Plaque Psoriasis Clinical Trial

— SPECTREM  

Official title:

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039189
• Other study ID #: CR109328
• Secondary ID: CNTO1959PSO3017
• Status: Recruiting
• Phase: Phase 3
• Start date: August 24, 2023
• Est. completion date: May 26, 2025

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 26, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention

• All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (>=) 3, face with facial psoriasis IGA >=3, intertriginous with intertriginous psoriasis IGA >=3, or genital with static physician global assessment of genitalia (sPGA-G) >=3

• All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening

• All participants be a candidate for phototherapy or systemic treatment for psoriasis

Exclusion Criteria:

• Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization

• Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

• For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded

• Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)

• Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Related Conditions & MeSH terms

• Moderate Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Guselkumab
Guselkumab will be administered as subcutaneous injection.
• Placebo
Placebo will be administered as subcutaneous injection.

Locations

Country	Name	City	State
Canada	CCA Medical Research Corporation	Ajax	Ontario
Canada	Beacon Dermatology	Calgary	Alberta
Canada	Rejuvenation Dermatology Clinic Edmonton Downtown	Edmonton	Alberta
Canada	Brunswick Dermatology Center	Fredericton	New Brunswick
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Dr Wei Jing Loo Medicine Professional Corporation	London	Ontario
Canada	North York Research Inc	North York	Ontario
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Ontario
Canada	JRB Research Inc	Ottawa	Ontario
Canada	The Centre de recherche Saint-Louis	Quebec
Canada	Dr. Chih-ho Hong Medical	Surrey	British Columbia
Canada	Enverus Medical	Surrey	British Columbia
Canada	Canadian Dermatology Center	Toronto	Ontario
Canada	FACET Dermatology	Toronto	Ontario
Canada	Research Toronto	Toronto	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario
Canada	Winnipeg Clinic	Winnipeg	Manitoba
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Atlanta Biomedical Clinical Research	Atlanta	Georgia
United States	Bellair Dermatology	Bellaire	Texas
United States	Bexley dermatology research	Bexley	Ohio
United States	Cahaba Research Inc	Birmingham	Alabama
United States	Total Dermatology	Birmingham	Alabama
United States	TrueBlue Clinical Research	Brandon	Florida
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	Accellacare Research of Cary	Cary	North Carolina
United States	Dermatology and Laser Center of Charleston	Charleston	South Carolina
United States	Darst Dermatology	Charlotte	North Carolina
United States	Kindred Hair and Skin Center	Columbia	Maryland
United States	Remington Davis Inc	Columbus	Ohio
United States	Florida Academic Dermatology Centers	Coral Gables	Florida
United States	Bare Dermatology	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Modern Research Associates PLLC	Dallas	Texas
United States	Revival Research	Doral	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	University of Conn Health Center	Farmington	Connecticut
United States	Palmetto Clinical Trial Services, LLC	Fountain Inn	South Carolina
United States	First OC Dermatology	Fountain Valley	California
United States	Center for Clinical Studies	Houston	Texas
United States	Suzanne Bruce and Associates - The Center for Skin Research	Houston	Texas
United States	Piedmont Plastic Surgery and Dermatology	Huntersville	North Carolina
United States	Glick Research Institute	Margate	Florida
United States	Apex Dermatology Mayfield Heights	Mayfield Heights	Ohio
United States	Miami VA Healthcare System	Miami	Florida
United States	Frontier Derm Partners CRO, LLC	Mill Creek	Washington
United States	Nashville Skin: Comprehensive Dermatology Center	Nashville	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Markowitz Medical OptiSkin	New York	New York
United States	Tory P. Sullivan, M.D., PA	North Miami Beach	Florida
United States	DermCare, LLC	Quincy	Massachusetts
United States	Practice Wang	Riverside	California
United States	DermAssociates, PC	Rockville	Maryland
United States	Lawrence J Green MD LLC	Rockville	Maryland
United States	Progressive Clinical Research	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Rehlen, Bartlow, Goodman and Baron Dermatology Group	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Acclaim Dermatology	Sugar Land	Texas
United States	Henry Ford Medical Center	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16	Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. 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).	Week 16
Secondary	Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16	Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).	Baseline, Week 16
Secondary	Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16	Change from baseline in PASI score at Week 16 will be reported. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.	Baseline, Week 16
Secondary	Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) at Week 16	Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. 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).	Week 16
Secondary	Percentage of Participants who Achieve a PASI 90 Response at Week 16	Percentage of participants who achieve a PASI 90 response at Week 16 will be reported. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline.	Week 16
Secondary	Percentage of Participants who Achieve a PASI 100 Response at Week 16	Percentage of participants who achieve a PASI 100 response at Week 16 will be reported. 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 erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.	Week 16
Secondary	Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline	Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score >=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).	Week 16
Secondary	Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline	Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score >=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).	Week 16
Secondary	Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline	Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).	Week 16
Secondary	Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline	Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).	Week 16
Secondary	Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16	Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 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. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Baseline, Week 16
Secondary	Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline	Percentage of participants who achieve >=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score >=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 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. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Week 16
Secondary	Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline	Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD >0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 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. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.	Week 16
Secondary	Number of Participants With Adverse Events (AEs)	Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to Week 56
Secondary	Number of Participants With Serious Adverse Events (SAEs)	Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.	Up to Week 56